Drugs / Enzalutamide
Regulatory milestones approvals, filings & regulatory actions · 23 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed castration-resistant prostate carcinoma 4 milestones | |||||
| Filed | US (FDA) | TALZENNA plus XTANDI | castration-resistant prostate carcinoma | 2026-07-22 | “accepted for Priority Review a supplemental New Drug Application (sNDA) for TALZENNA ® (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with...” pfizer.com ↗ |
| Filed | US (FDA) | XTANDI | castration-resistant prostate carcinoma | 2018-03-19 | “a supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide) has been accepted for filing” astellas.com ↗ |
| Filed | EU (EMA) | XTANDI | castration-resistant prostate carcinoma | 2018-03-16 | “In March 2018, the European Medicines Agency (EMA) validated and started the review process for Astellas’ application for a Type II Variation” astellas.com ↗ “EMA has validated and started the review process for Astellas’ application for a Type II Variation for enzalutamide” astellas.com ↗ “application filed with the EMA for TALZENNA in combination with XTANDI for men with HRR gene-mutated mCSPC” pfizer.com ↗ “the European Medicines Agency (EMA) has validated the Type II Variation submitted for XTANDI” astellas.com ↗ |
| Filed | US (FDA) | XTANDI | castration-resistant prostate carcinoma | 2014-03-19 | “accepted for filing the supplemental New Drug Application (sNDA) to extend the indication for XTANDI® (enzalutamide) capsules” astellas.com ↗ |
| Filed progesterone-receptor positive breast cancer 2 milestones | |||||
| Filed | US (FDA) | XTANDI | progesterone-receptor positive breast cancer | 2019-08-21 | “has accepted for review the filing of a supplemental New Drug Application (sNDA) for XTANDI ® (enzalutamide) to add an indication” pfizer.com ↗ “has accepted for review the filing of a supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide) to add an indication” pfizer.com ↗ |
| Filed | EU (EMA) | XTANDI | progesterone-receptor positive breast cancer | 2019-07-24 | “acceptance by the European Medicines Agency (EMA) of a Type II Variation Application for regulatory review for the use of XTANDI™ (enzalutamide) in metastatic hormone-sensitive...” astellas.com ↗ |
| Filed prostate cancer, hereditary, X-linked 3 4 milestones | |||||
| Filed | China (NMPA) | XTANDI | prostate cancer, hereditary, X-linked 3 | 2023-09-19 | “NMPA) has accepted its New Drug Application (NDA) for XTANDI ® (enzalutamide)” astellas.com ↗ |
| Filed | EU (EMA) | XTANDI | prostate cancer, hereditary, X-linked 3 | 2023-09-12 | “EMA has validated its Type II variation for XTANDI ® (enzalutamide)” astellas.com ↗ |
| Filed | US (FDA) | XTANDI | prostate cancer, hereditary, X-linked 3 | 2023-08-23 | “FDA has accepted and granted Priority Review for the companies’ supplemental New Drug Application (sNDA) for XTANDI ® (enzalutamide)” astellas.com ↗ |
| Filed | Japan (PMDA) | — | prostate cancer, hereditary, X-linked 3 | 2013-05-24 | “has submitted an application for marketing approval of enzalutamide (generic name) to the Ministry of Health, Labour and Welfare in Japan” astellas.com ↗ |
| Approved Indication not stated 4 milestones | |||||
| Label expansions (10) | US (FDA) | XTANDI | — | 2014-09-10 – 2026-07-24 | fda.gov ↗ |
| Approved | EU (EMA) | Xtandi | — | 2013-06-21 | europa.eu ↗ |
| Refused (EMA) | EU (EMA) | Xtandi | — | 2013-04-26 | europa.eu ↗ |
| Approved | US (FDA) | XTANDI | — | 2012-08-31 | fda.gov ↗ |
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News releases announcing trial results or a regulatory action · 113
| Date | Issuer | Release |
|---|---|---|
| 2026-07-22 | Pfizer | Regulatory FDA Grants Priority Review for Pfizer’s TALZENNA Plus XTANDI for the Treatment of Metastatic Prostate Cancer pfizer.com ↗ |
| 2026-06-26 | Lupin Limited | Regulatory Lupin Receives Tentative Approval from U.S. FDA for Enzalutamide Tablets lupin.com ↗
Mumbai, India, Naples, Fla, June 26, 2026: Global pharma major Lupin Limited (Lupin) today announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Enzalutamide Tablets, 40 mg, 80 mg, 120 mg, and 160 mg. |
| 2026-05-30 | Pfizer | Results TALZENNA Plus XTANDI Improves Radiographic Progression-Free Survival by More Than 50% in Metastatic Prostate Cancer pfizer.com ↗
TALZENNA plus XTANDI demonstrated a 52% reduction in the risk of radiographic progression or death compared to placebo plus XTANDI (Hazard Ratio [HR] of 0.48; 95% Confidence Interval [CI], 0.36–0.65; p ˂ 0.0001). |
| 2026-05-29 | Alessa Therapeutics Inc. | Results Alessa Therapeutics Announces Enolen Phase 1 Study Presentation Receives “Best Poster” Award at the American Urological Association Annual Meeting alessatherapeutics.com ↗
These implantations achieved very high intraprostatic enzalutamide levels with minimal systemic drug exposure and resulted in no delay to surgery. |
| 2026-04-21 | Pfizer | Results Pfizer Showcases Oncology Innovation and Next-Generation Pipeline at ASCO 2026 pfizer.com ↗
These data follow the announcement of topline results in March 2026 and support the potential of TALZENNA plus XTANDI to deliver benefit earlier in the disease course. |
| 2026-03-19 | Pfizer | Results TALZENNA Plus XTANDI Significantly Improves Radiographic Progression-Free Survival in Metastatic Prostate Cancer pfizer.com ↗
The study met its primary endpoint, with TALZENNA plus XTANDI demonstrating a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS), compared to placebo plus XTANDI. |
| 2026-03-16 | Alessa Therapeutics Inc. | Results Alessa Therapeutics Announces Positive Preliminary Safety and Efficacy Data from Enolen Phase 1 Trial alessatherapeutics.com ↗
These implantations achieved very high intraprostatic enzalutamide levels with minimal systemic drug exposure and resulted in no delay to surgery. |
| 2026-02-27 | Evopoint Biosciences Inc. | Results 信诺维于ASCO GU公布依格美妥司他（XNW5004）治疗mCRPC最新数据，mrPFS超18个月 evopointbio.com ↗
疗效结果显示，整体阿比特龙治疗失败以及1200mg剂量组患者的中位影像学无进展生存期（mrPFS）均为18.6m，mOS均未达到（95% 置信区间：18.56 - 未达到）。 |
| 2026-02-26 | Bayer | Results Bayer’s radium-223 dichloride plus enzalutamide demonstrates significant overall survival benefit in the PEACE-3 trial in patients with metastatic castration-resistant prostate cancer with bone metastases bayer.com ↗
Final overall survival (OS) results from the PEACE-3 trial show enzalutamide in combination with radium-223 dichloride reduces the risk of death by 24% versus enzalutamide alone in men with metastatic castration-resistant prostate cancer (mCRPC) and bone metastases |
| 2026-01-08 | Alessa Therapeutics Inc. | Regulatory Alessa Therapeutics Announces FDA Fast Track Designation for Enolen, A First-Of-Its-Kind Treatment for Localized Prostate Cancer alessatherapeutics.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Enolen®, the Company’s lead product candidate for the treatment of low to intermediate risk, localized prostate cancer. |
| 2025-10-19 | Pfizer | Results XTANDI® Plus Leuprolide Reduced Risk of Death by 40% vs Leuprolide Alone in Men with a Type of Advanced Prostate Cancer pfizer.com ↗
The probability of survival at 8 years was an unprecedented 78.9% with XTANDI plus leuprolide versus 69.5% with leuprolide, in men with non-metastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence |
| 2025-08-21 | Nanoform Finland Plc | Results Nanoform Q2 2025 report: Continued progress on many fronts, supportive first preliminary pivotal nanoenzalutamide study results nanoform.com ↗
First preliminary pivotal study results supportive for project Nanoenzalutamide to continue to progress towards the markets. |
| 2025-07-10 | Pfizer | Results XTANDI® Plus Leuprolide Significantly Improves Survival Outcomes in Men with Non-Metastatic Hormone-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence pfizer.com ↗
For patients treated with XTANDI plus leuprolide versus placebo plus leuprolide, EMBARK met the key secondary endpoint with a statistically significant and clinically meaningful improvement in OS. |
| 2025-05-23 | Astellas Pharma Inc | Results Astellas and Pfizer’s XTANDI TM (enzalutamide) Shows Long-Term Overall Survival in Metastatic Hormone-Sensitive Prostate Cancer astellas.com ↗
Five-year follow-up data from the Phase 3 ARCHES trial shows XTANDI (enzalutamide) plus androgen deprivation therapy (ADT) reduces risk of death by 30% |
| 2025-05-22 | Pfizer | Results Astellas and Pfizer’s XTANDI™ (enzalutamide) Shows Long-Term Overall Survival in Metastatic Hormone-Sensitive Prostate Cancer pfizer.com ↗
Five-year follow-up data from the Phase 3 ARCHES trial shows XTANDI (enzalutamide) plus androgen deprivation therapy (ADT) reduces risk of death by 30% |
| 2025-05-20 | Astellas Pharma Inc | Results Astellas Presents New Data that Explores Potential of its Cancer Therapies at 2025 ASCO Annual Meeting astellas.com ↗
Abiraterone acetate is associated with shorter overall survival than enzalutamide in patients with chemotherapy naïve metastatic castration-resistant prostate cancer: Real world data from the Flatiron electronic health records database |
| 2025-02-13 | Pfizer | Results Pfizer’s TALZENNA® in Combination with XTANDI® Improves Survival Outcomes in Metastatic Castration Resistant Prostate Cancer pfizer.com ↗
TALZENNA + XTANDI improved median OS by almost 9 months in unselected patients (Cohort 1) and by 14 months in patients selected for HRR mutations (Cohort 2) versus standard of care XTANDI |
| 2025-01-28 | Pfizer | Results Pfizer to Showcase Advancements Across Genitourinary Cancers at ASCO GU Cancers Symposium pfizer.com ↗
Detailed overall survival (OS) results from the pivotal Phase 3 TALAPRO-2 trial of TALZENNA ® in combination with XTANDI ® in patients with metastatic castration-resistant prostate cancer (mCRPC) |
| 2024-10-31 | ESSA Pharmaceuticals | Results ESSA Pharma Announces Termination of Phase 2 Study Evaluating Masofaniten Combined with Enzalutamide in Patients with Metastatic Castration-Resistant Prostate Cancer essapharma.com ↗
Efficacy signals observed will not achieve ESSA's target product profile in patients with metastatic castration-resistant prostate cancer naïve to second-generation antiandrogens |
| 2024-10-10 | Pfizer | Results Pfizer’s TALZENNA® in Combination with XTANDI® Prolongs Overall Survival in Phase 3 TALAPRO-2 Trial pfizer.com ↗ |
| 2024-10-02 | Zydus Lifesciences Limited | Regulatory Zydus receives tentative approval from USFDA for Enzalutamide Tablets zyduslife.com ↗
Zydus receives tentative approval from USFDA for Enzalutamide Tablets, 40 mg and 80 mg |
| 2024-10-02 | Janssen Research & Development, LLC | Results ERLEADA® (apalutamide) demonstrates statistically significant and clinically meaningful improvement in overall survival compared to enzalutamide in patients with metastatic castration-sensitive prostate cancer jnj.com ↗
Johnson & Johnson (NYSE: JNJ) today announced the results of a landmark real-world, head-to-head study showing that ERLEADA®(apalutamide) provided a statistically significant overall survival benefit at 24 months compared to enzalutamide in patients with metastatic castration-sensitive prostate cancer (mCSPC). |
| 2024-10-02 | Janssen Research & Development, LLC | Results ERLEADA® (apalutamide) demonstrates statistically significant and clinically meaningful improvement in overall survival compared to enzalutamide in patients with metastatic castration-sensitive prostate cancer jnj.com ↗ |
| 2024-09-28 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from USFDA for Enzalutamide Capsules, 40 mg zyduslife.com ↗ |
| 2024-09-13 | ESSA Pharmaceuticals | Results ESSA Pharma Presents Updated Phase 1/2 Masofaniten (EPI-7386) Clinical Data at the 2024 ESMO Congress essapharma.com ↗
Across all dosing cohorts, 88% of patients achieved PSA90, 69% of patients achieved PSA90 in less than 90 days, and 63% of patients achieved PSA <0.2ng/mL. |
| 2024-09-11 | Astellas Pharma Inc | Results Astellas Presents Scientific Progress in Advanced and Hard-to-Treat Cancers at ESMO 2024 astellas.com ↗
These results support the benefits of enzalutamide both in combination with leuprolide and as monotherapy in patients aged <70 and ≥70 years. |
| 2024-07-02 | Astellas Pharma Inc | Regulatory China’s National Medical Products Administration Approves XTANDI ® (enzalutamide) in Metastatic Hormone-Sensitive Prostate Cancer astellas.com ↗
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has approved XTANDI® (enzalutamide) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). |
| 2024-04-23 | Astellas Pharma Inc | Regulatory Astellas’ XTANDI TM (Enzalutamide) Granted European Commission Approval for Use in Additional Recurrent Early Prostate Cancer Treatment Setting astellas.com ↗ |
| 2024-03-22 | Astellas Pharma Inc | Regulatory Astellas Receives Positive CHMP Opinion for XTANDI TM in Additional Recurrent Early Prostate Cancer Treatment Setting astellas.com ↗
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of XTANDI ™ (enzalutamide) as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high risk biochemical recurrent (BCR) non-metastatic hormone sensitive prostate cancer (nmHSPC) who are unsuitable for salvage radiotherapy. |
| 2024-01-26 | Nanoform Finland Plc | Results Inside information made public: Nanoform Announces Important Milestone with Promising Clinical Results for Patient-Centric Nanotechnology-Enhanced Enzalutamide nanoform.com ↗
Helsinki, Finland – January 26, 2024 – Nanoform Finland Plc (“Nanoform”), the medicine performance-enhancing company, today announced that one of its leading nanoformulation drug products had received promising clinical results. |
| 2024-01-25 | ESSA Pharmaceuticals | Results ESSA Pharma Presents Updated Phase 1 Masofaniten (EPI-7386) Clinical Data at the 2024 ASCO Genitourinary Cancers Symposium essapharma.com ↗
Combination of masofaniten plus enzalutamide continues to be well tolerated with deep and durable reductions in PSA in patients with mCRPC |
| 2024-01-08 | Pfizer | Regulatory European Commission Approves Pfizer’s TALZENNA® in Combination with XTANDI® for Adult Patients with Metastatic Castration-Resistant Prostate Cancer pfizer.com ↗
TALZENNA is the first and only PARP inhibitor approved in combination with standard of care XTANDI for mCRPC patients in the European Union |
| 2023-11-16 | Astellas Pharma Inc | Regulatory Pfizer and Astellas' XTANDI ® Approved by U.S. FDA in Earlier Prostate Cancer Treatment Setting astellas.com ↗
With this approval, XTANDI becomes the first and only androgen receptor signaling inhibitor approved by the FDA for the treatment of patients with nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR). |
| 2023-10-26 | ESSA Pharmaceuticals | Results ESSA Pharma Presents Updated Phase 1 Masofaniten (EPI-7386) Clinical Data at the 30th Annual Prostate Cancer Foundation Scientific Retreat essapharma.com ↗
Across all cohorts of patients including those recently enrolled into cohort four, 81% of patients achieved PSA90, 69% of patients achieved PSA90 in less than 90 days, and 56% of patients achieved PSA <0.2ng/mL |
| 2023-10-21 | ESSA Pharmaceuticals | Results ESSA Pharma Presents Updated Phase 1 Masofaniten (EPI-7386) Clinical Data at the European Society of Medical Oncology 2023 Congress essapharma.com ↗
Combination of masofaniten plus enzalutamide continues to be well tolerated with deep and durable reductions in PSA in patients with mCRPC |
| 2023-09-19 | Astellas Pharma Inc | Regulatory China’s National Medical Products Administration Accepts New Drug Application for XTANDI ® (enzalutamide) in Metastatic Hormone-Sensitive Prostate Cancer astellas.com ↗
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for XTANDI ® (enzalutamide) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). |
| 2023-09-12 | Astellas Pharma Inc | Regulatory European Medicines Agency Validates Type II Variation for Astellas' XTANDI ® (enzalutamide) for Treatment of Non-Metastatic Hormone-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence astellas.com ↗
European Medicines Agency Validates Type II Variation for Astellas' XTANDI ® (enzalutamide) for Treatment of Non-Metastatic Hormone-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence |
| 2023-08-23 | Astellas Pharma Inc | Regulatory FDA Grants Priority Review for XTANDI ® in Non-Metastatic Castration-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence astellas.com ↗
FDA Grants Priority Review for XTANDI ® in Non-Metastatic Castration-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence |
| 2023-06-20 | Pfizer | Regulatory Pfizer’s TALZENNA® in Combination with XTANDI® Receives U.S. FDA Approval pfizer.com ↗
TALZENNA is first and only PARP inhibitor approved for use with an existing standard of care (XTANDI) for adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration resistant prostate cancer (mCRPC) |
| 2023-04-29 | Pfizer | Results XTANDI® (enzalutamide) plus Leuprolide Reduced the Risk of Metastasis by 58% in Non-Metastatic Hormone-Sensitive Prostate Cancer versus Placebo plus Leuprolide pfizer.com ↗ |
| 2023-04-29 | Astellas Pharma Inc | Results XTANDI ® (enzalutamide) plus Leuprolide Reduced the Risk of Metastasis by 58% in Non-Metastatic Hormone-Sensitive Prostate Cancer versus Placebo plus Leuprolide astellas.com ↗ |
| 2023-03-17 | Astellas Pharma Inc | Results Phase 3 Study Shows XTANDI ® (enzalutamide) plus Leuprolide Significantly Improves Metastasis-Free Survival in Men with Non-Metastatic Prostate Cancer astellas.com ↗
The study met its primary endpoint with a statistically significant and clinically meaningful improvement in metastasis-free survival (MFS) for patients treated with XTANDI plus leuprolide versus placebo plus leuprolide. |
| 2023-03-16 | Pfizer | Results Phase 3 Study Shows XTANDI® (enzalutamide) plus Leuprolide Significantly Improves Metastasis-Free Survival in Men with Non-Metastatic Prostate Cancer pfizer.com ↗
The study met its primary endpoint with a statistically significant and clinically meaningful improvement in metastasis-free survival (MFS) for patients treated with XTANDI plus leuprolide versus placebo plus leuprolide. |
| 2023-03-14 | Astellas Pharma Inc | Results Astellas Announces Phase 3 China ARCHES Study of XTANDI ® Meets Primary Endpoint astellas.com ↗
The study met its primary endpoint, demonstrating a statistically significant improvement in time to prostate-specific antigen (PSA) progression (TTPP), defined as a ≥ 25% increase and an absolute increase of ≥ 2 µg/L (2 ng/mL) above the nadir (i.e., lowest PSA value observed post baseline or at baseline), which is confirmed by a second consecutive value at least 3 weeks later. |
| 2023-02-28 | Merck Sharp & Dohme LLC | Results Merck Provides Update on Phase 3 Trials KEYNOTE-641 and KEYNOTE-789 merck.com ↗
Merck is discontinuing the Phase 3 KEYNOTE-641 trial |
| 2023-02-16 | Pfizer | Results Pfizer Announces Positive TALZENNA® and XTANDI® Combination Data from Phase 3 TALAPRO-2 Study pfizer.com ↗
In the final rPFS analysis, TALZENNA plus XTANDI reduced the risk of disease progression or death by 37% versus placebo plus XTANDI (Hazard Ratio [HR]: 0.63; 95% Confidence Interval [CI], 0.51–0.78; P< 0.001). |
| 2023-02-13 | ESSA Pharmaceuticals | Results ESSA Pharma Announces Presentations at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) essapharma.com ↗
We are encouraged that EPI-7386 has continued to be well-tolerated and safe as well as demonstrate initial anti-tumor activity both as a monotherapy and in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer, |
| 2023-01-25 | Merck Sharp & Dohme LLC | Results Merck Announces KEYNOTE-991 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus Enzalutamide and Androgen Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer to Stop for Futility merck.com ↗
At the interim analysis, KEYTRUDA in combination with enzalutamide and ADT did not demonstrate an improvement in overall survival (OS) or radiographic progression-free survival (rPFS), the trial’s dual primary endpoints, compared to placebo plus enzalutamide and ADT. |
| 2022-10-26 | ESSA Pharmaceuticals | Results Updated Results from the Phase 1/2 Study of ESSA's Lead Candidate EPI-7386 in Combination with Enzalutamide Highlighted at the 29th Annual Prostate Cancer Foundation Scientific Retreat essapharma.com ↗
EPI-7386 in combination with enzalutamide was safe and well-tolerated at the doses tested with clinically relevant drug exposures and deep and durable prostate specific antigen ("PSA") reductions observed in five of six patients |
| 2022-10-04 | Pfizer | Results Pfizer Announces Positive Topline Results from Phase 3 TALAPRO-2 Trial pfizer.com ↗
The study met its primary endpoint with a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS) compared with placebo plus XTANDI. |
| 2022-06-27 | ESSA Pharmaceuticals | Results ESSA Pharma Presents Clinical Update on EPI-7386 Monotherapy and Combination Therapy Clinical Development essapharma.com ↗
the drugs can be combined safely and result in drug levels of both drugs which are predicted to be active based upon clinical and preclinical data. |
| 2022-02-14 | Janssen Research & Development, LLC | Results New ERLEADA® (apalutamide) Analysis Demonstrates Rapid, Deep Prostate-Specific Antigen (PSA) Response in Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC) jnj.com ↗
By six months, 69.3 percent of patients with mCSPC initiated on ERLEADA®attained PSA90 response and 55.6 percent for enzalutamide (HR=1.56; p=0.014). |
| 2021-09-17 | Pfizer | Results Astellas’ and Pfizer’s XTANDI® (enzalutamide) Reduced Risk of Death by 34% in Men with Metastatic Hormone-Sensitive Prostate Cancer in Phase 3 ARCHES Study pfizer.com ↗
In the study, XTANDI plus ADT reduced the risk of death by 34% (n=1,150; hazard ratio [HR]=0.66; [95% confidence interval [CI]: 0.53-0.81]; p<0.0001) compared to placebo plus ADT. |
| 2021-09-17 | Astellas Pharma Inc | Results Astellas’ and Pfizer’s XTANDI® (enzalutamide) Reduced Risk of Death by 34% in Men with Metastatic Hormone-Sensitive Prostate Cancer in Phase 3 ARCHES Study astellas.com ↗
In the study, XTANDI plus ADT reduced the risk of death by 34% (n=1,150; hazard ratio [HR]=0.66; [95% confidence interval [CI]: 0.53-0.81]; p<0.0001) compared to placebo plus ADT. |
| 2021-06-24 | Zenith Epigenetics | Results Zenith Epigenetics Announces a Publication Highlighting the Role of ZEN-3694 in Overcoming Resistance to Therapies in Metastatic Castration-Resistant Prostate Cancer zenithepigenetics.com ↗
High expression of BRD4 and E2F1 were also observed in the tumors of two patients with treatment emergent neuroendocrine prostate cancer, and both patients had a response to ZEN-3694 + enzalutamide, consistent with the role of ZEN-3694 in overcoming resistance to ARSi in this aggressive form of prostate cancer. |
| 2021-05-04 | Astellas Pharma Inc | Regulatory Astellas’ XTANDI™ (enzalutamide) Approved by European Commission for Men with Metastatic Hormone-Sensitive Prostate Cancer astellas.com ↗
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced today that the European Commission (EC) has approved an additional indication for the oral once-daily therapy XTANDI ™ (enzalutamide) for adult men with metastatic hormone-sensitive prostate cancer (mHSPC, also known as metastatic castration-sensitive prostate cancer or mCSPC). |
| 2021-04-06 | Bayer | Results Bayer to present new clinical data in indolent non-Hodgkin’s Lymphoma and additional research on its oncology portfolio at AACR Annual Meeting 2021 bayer.com ↗
In addition, preclinical data on the synergistic antitumor effect of radium-223 dichloride and enzalutamide will be presented. |
| 2021-03-29 | Astellas Pharma Inc | Regulatory Astellas Receives Positive CHMP Opinion for XTANDI TM (enzalutamide) for Patients with Metastatic Hormone-Sensitive Prostate Cancer astellas.com ↗ |
| 2021-02-08 | Bayer | Results New data presented at 2021 ASCO GU Cancers Symposium add to robustness of the overall survival benefit and favorable safety profile for Nubeqa™ bayer.com ↗
Radium-223 + enzalutamide resulted in significant long-term clinical benefit when compared to enzalutamide alone in mCRPC patients, without compromising safety. |
| 2020-11-06 | Astellas Pharma Inc | Regulatory XTANDI® (enzalutamide soft capsules) Approved by China NMPA for the Treatment of Non-Metastatic Castration-Resistant Prostate Cancer astellas.com ↗
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that the China National Medical Products Administration (NMPA) has approved XTANDI ® (enzalutamide soft capsules) for the treatment of adult men with non-metastatic castration-resistant prostate cancer (nmCRPC) with high risk of metastasis. |
| 2020-09-20 | Merck Sharp & Dohme LLC | Results LYNPARZA Reduced Risk of Death by 31% vs. Enzalutamide or Abiraterone for Men with BRCA1/2 or ATM-Mutated Metastatic Castration Resistant Prostate Cancer Who Progressed Following Enzalutamide or Abiraterone in Phase 3 PROfound Trial merck.com ↗
Median OS was 19.1 months for LYNPARZA vs. 14.7 months for enzalutamide or abiraterone, despite 66% of men on these treatments having crossed over to receive treatment with LYNPARZA following disease progression. |
| 2020-05-29 | Pfizer | Results Final PROSPER Results Show XTANDI® (enzalutamide) Significantly Extends Overall Survival in Men with Non-Metastatic Castration-Resistant Prostate Cancer pfizer.com ↗
In the trial, XTANDI plus ADT reduced the risk of death by 27% (n=1,401; hazard ratio [HR]=0.73; [95% confidence interval [CI]: 0.61-0.89]; p=0.001) compared to placebo plus ADT. |
| 2020-05-29 | Astellas Pharma Inc | Regulatory XTANDI® (enzalutamide) Approved by Japan MHLW for the Treatment of Prostate Cancer with Distant Metastasis astellas.com ↗
This is in addition to an existing indication for castration-resistant prostate cancer (CRPC). |
| 2020-05-29 | Astellas Pharma Inc | Results Final PROSPER Results Show XTANDI® (enzalutamide) Significantly Extends Overall Survival in Men with Non-Metastatic Castration-Resistant Prostate Cancer astellas.com ↗
In the trial, XTANDI plus ADT reduced the risk of death by 27% (n=1,401; hazard ratio [HR]=0.73; [95% confidence interval [CI]: 0.61-0.89]; p=0.001) compared to placebo plus ADT. |
| 2020-02-11 | Pfizer | Results XTANDI® (enzalutamide) Demonstrates Significant Improvement in Overall Survival in Phase 3 PROSPER Trial of Patients with nmCRPC pfizer.com ↗
The results demonstrated a statistically significant improvement in OS in patients with nmCRPC who were treated with XTANDI plus ADT. |
| 2020-02-11 | Astellas Pharma Inc | Results XTANDI® (enzalutamide) Demonstrates Significant Improvement in Overall Survival in Phase 3 PROSPER Trial of Patients with nmCRPC astellas.com ↗
The results demonstrated a statistically significant improvement in OS in patients with nmCRPC who were treated with XTANDI plus ADT. |
| 2019-12-19 | Zenith Epigenetics | Results Zenith Epigenetics Announces Clinical Advancement of ZEN-3694 zenithepigenetics.com ↗
In these poor prognosis patients, where there is no standard of care, the data show that ZEN-3694 + enzalutamide provided a significant and meaningful radiographic progression-free survival benefit of approximately 44 weeks compared to approximately 24 weeks for patients receiving only the AR antagonist. |
| 2019-12-17 | Astellas Pharma Inc | Regulatory XTANDI® (enzalutamide) Approved by U.S. FDA for the Treatment of Metastatic Castration-Sensitive Prostate Cancer astellas.com ↗
Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). |
| 2019-12-16 | Pfizer | Regulatory XTANDI® (enzalutamide) Approved by U.S. FDA for the Treatment of Metastatic Castration-Sensitive Prostate Cancer pfizer.com ↗
With this approval, XTANDI is now the first and only oral treatment approved by the FDA in three distinct types of advanced prostate cancer – non-metastatic and metastatic castration-resistant prostate cancer (CRPC) and mCSPC. |
| 2019-11-26 | Astellas Pharma Inc | Regulatory Astellas Announces the Approval of XTANDI® (enzalutamide) by the China National Medical Products Administration (NMPA) Approval based on Asian PREVAIL study of men with metastatic castration-resistant prostate cancer astellas.com ↗
Astellas Announces the Approval of XTANDI® (enzalutamide) by the China National Medical Products Administration (NMPA) |
| 2019-08-22 | Astellas Pharma Inc | Regulatory U.S. FDA Grants XTANDI® (enzalutamide) Application Priority Review for the Treatment of Men with Metastatic Hormone-Sensitive Prostate Cancer astellas.com ↗ |
| 2019-08-21 | Pfizer | Regulatory U.S. FDA Grants XTANDI® (enzalutamide) Application Priority Review for the Treatment of Men with Metastatic Hormone-Sensitive Prostate Cancer pfizer.com ↗
The application has also been granted Priority Review |
| 2019-07-30 | Astellas Pharma Inc | Regulatory Astellas Submits Supplemental New Drug Application for Approval of Additional Indication of XTANDI® for the Treatment of Men with Metastatic Hormone-Sensitive Prostate Cancer in Japan astellas.com ↗
Astellas Submits Supplemental New Drug Application for Approval of Additional Indication of XTANDI® for the Treatment of Men with Metastatic Hormone-Sensitive Prostate Cancer in Japan |
| 2019-07-24 | Astellas Pharma Inc | Regulatory Astellas Announces Acceptance by the European Medicines Agency of a Variation Application for Regulatory Review for Use of XTANDITM (enzalutamide) in metastatic Hormone-Sensitive Prostate Cancer astellas.com ↗
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced the acceptance by the European Medicines Agency (EMA) of a Type II Variation Application for regulatory review for the use of XTANDI™ (enzalutamide) in metastatic hormone-sensitive prostate cancer (mHSPC) patients. |
| 2019-02-14 | Merck Sharp & Dohme LLC | Results Merck Increases Focus on Advanced Prostate Cancer, Expanding Immuno-Oncology Program with Three New Phase 3 Trials merck.com ↗
Data from Three Cohorts of Phase 1b/2 KEYNOTE-365 Study to Be Presented Today at the 2019 Genitourinary Cancers Symposium (ASCO GU) |
| 2019-02-11 | Pfizer | Results Phase 3 ARCHES Trial Shows XTANDI® (enzalutamide) Significantly Improved Radiographic Progression-Free Survival in Men with Metastatic Hormone-Sensitive Prostate Cancer pfizer.com ↗
The results show that XTANDI ® (enzalutamide) plus androgen deprivation therapy (ADT) met the primary endpoint by significantly reducing the risk of radiographic progression or death by 61% versus ADT alone (n=1,150; HR=0.39 [95% CI: 0.30-0.50]; p<0.0001) . |
| 2019-02-11 | Astellas Pharma Inc | Results Phase 3 ARCHES Trial Shows XTANDI® (enzalutamide) Significantly Improved Radiographic Progression-Free Survival in Men with Metastatic Hormone-Sensitive Prostate Cancer astellas.com ↗
The results show that XTANDI® (enzalutamide) plus androgen deprivation therapy (ADT) met the primary endpoint by significantly reducing the risk of radiographic progression or death by 61% versus ADT alone (n=1,150; HR=0.39 [95% CI: 0.30-0.50]; p<0.0001). |
| 2018-12-20 | Pfizer | Results Astellas and Pfizer Announce Positive Top-Line Results from Phase 3 ARCHES Trial of XTANDI® (enzalutamide) in Men with Metastatic Hormone-Sensitive Prostate Cancer pfizer.com ↗
“The results from ARCHES demonstrate a statistically significant improvement in a key marker of disease progression – radiographic progression-free survival,” said Steven Benner, M.D., senior vice president and global therapeutic area head, Oncology Development, Astellas. |
| 2018-12-20 | Astellas Pharma Inc | Results Astellas and Pfizer Announce Positive Top-Line Results from Phase 3 ARCHES Trial of XTANDI® (enzalutamide) in Men with Metastatic Hormone-Sensitive Prostate Cancer astellas.com ↗ |
| 2018-10-29 | Astellas Pharma Inc | Regulatory Astellas Receives European Approval for XTANDI™ (enzalutamide) for Adult Men with High-Risk Non-Metastatic Castration-Resistant Prostate Cancer astellas.com ↗ |
| 2018-09-25 | Astellas Pharma Inc | Regulatory Astellas Receives Positive CHMP Opinion for XTANDI TM (enzalutamide) for Adult Men with High-Risk Non-Metastatic Castration-Resistant Prostate Cancer astellas.com ↗ |
| 2018-09-04 | Zenith Epigenetics | Results Zenith Epigenetics Announces Publication of a Case Study From its Ongoing mCRPC Clinical Study zenithepigenetics.com ↗
Using CURATE.AI-suggested dosing of ZEN-3694 and enzalutamide, the patient achieved a durable response now ongoing for > 16 months. |
| 2018-07-17 | Astellas Pharma Inc | Regulatory U.S. FDA Approves XTANDI® (enzalutamide) for the Treatment of Men with Non-Metastatic Castration-Resistant Prostate Cancer (CRPC) - First and Only Oral Treatment FDA-Approved for Both Non-Metastatic and Metastatic CRPC - astellas.com ↗
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide), following FDA Priority Review designation, based on results from the Phase 3 PROSPER trial. |
| 2018-07-13 | Pfizer | Regulatory U.S. FDA Approves XTANDI® (enzalutamide) for the Treatment of Men with Non-Metastatic Castration-Resistant Prostate Cancer (CRPC) pfizer.com ↗
This approval makes XTANDI the first and only oral medication FDA-approved for both non-metastatic and metastatic CRPC. |
| 2018-06-29 | Astellas Pharma Inc | Results Results from Pivotal Phase 3 PROSPER Trial of XTANDI® (enzalutamide) in Men with Non-Metastatic Castration-Resistant Prostate Cancer Published in New England Journal of Medicine astellas.com ↗
The primary endpoint of metastasis-free survival (MFS), was 36.6 months for men who received enzalutamide compared to 14.7 months with ADT alone (n=1401; HR=0.29 [95% CI: 0.24-0.35]; p<0.001). |
| 2018-03-19 | Pfizer | Regulatory U.S. FDA Grants Priority Review for a Supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide) in Non-Metastatic Castration-Resistant Prostate Cancer (CRPC) pfizer.com ↗
Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) announced today that a supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide) has been accepted for filing and granted Priority Review designation by the U.S. Food and Drug Administration (FDA). |
| 2018-03-19 | Astellas Pharma Inc | Regulatory U.S. FDA Grants Priority Review for a Supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide) in Non-Metastatic Castration-Resistant Prostate Cancer (CRPC) astellas.com ↗
Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) announced today that a supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide) has been accepted for filing and granted Priority Review designation by the U.S. Food and Drug Administration (FDA). |
| 2018-03-16 | Astellas Pharma Inc | Regulatory European Medicines Agency Accepts Type II Variation Application Filing for XTANDITM (enzalutamide) In Non-Metastatic Castration-resistant Prostate Cancer astellas.com ↗ |
| 2018-03-01 | Astellas Pharma Inc | Regulatory Astellas Receives Approval for XTANDI Tablets, a Treatment for Castration-Resistant Prostate Cancer, in Japan astellas.com ↗ |
| 2018-02-05 | Pfizer | Results Phase 3 PROSPER Trial Shows XTANDI® (enzalutamide) Significantly Reduced the Risk of Metastasis or Death by 71 Percent in Men with Non-Metastatic Castration-Resistant Prostate Cancer pfizer.com ↗
The results show that the use of XTANDI® (enzalutamide) plus androgen deprivation therapy (ADT) significantly reduced the risk of developing metastases or death by 71 percent compared to ADT alone. |
| 2018-02-05 | Astellas Pharma Inc | Results Phase 3 PROSPER Trial Shows XTANDI® (enzalutamide) Significantly Reduced the Risk of Metastasis or Death by 71 Percent in Men with Non-Metastatic Castration-Resistant Prostate Cancer astellas.com ↗
The results show that the use of XTANDI® (enzalutamide) plus androgen deprivation therapy (ADT) significantly reduced the risk of developing metastases or death by 71 percent compared to ADT alone. |
| 2017-09-14 | Pfizer | Results Pfizer and Astellas Announce Positive Top-Line Results from Phase 3 PROSPER Trial of XTANDI (enzalutamide) in Patients with Non-Metastatic Castration-Resistant Prostate Cancer pfizer.com ↗ |
| 2017-09-14 | Astellas Pharma Inc | Results Pfizer and Astellas Announce Positive Top-Line Results from Phase 3 PROSPER Trial of XTANDI (enzalutamide) in Patients with Non-Metastatic Castration-Resistant Prostate Cancer astellas.com ↗ |
| 2016-12-14 | Pfizer | Results Pfizer and Astellas Announce Top-Line Results from Phase 4 PLATO Trial of XTANDI® (enzalutamide) Capsules in Patients with Metastatic Castration-Resistant Prostate Cancer pfizer.com ↗
Pfizer Inc. (NYSE:PFE) and Astellas Pharma Inc. (TSE:4503) today announced the Phase 4 PLATO study, evaluating the efficacy and safety of continued treatment with XTANDI ® (enzalutamide), plus abiraterone acetate and prednisone as compared to treatment with abiraterone acetate and prednisone alone, did not meet its primary endpoint of improvement in progression-free survival (PFS) in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (CRPC) whose prostate-specific antigen (PSA) has previously progressed on XTANDI. |
| 2016-10-21 | Pfizer | Regulatory FDA Approves Supplemental New Drug Application for XTANDI® (enzalutamide) Capsules in Advanced Prostate Cancer pfizer.com ↗ |
| 2016-10-21 | Astellas Pharma Inc | Regulatory FDA Approves Supplemental New Drug Application for XTANDI in Advanced Prostate Cancer astellas.com ↗
the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to update the U.S. product labeling for XTANDI® (enzalutamide) capsules |
| 2015-06-02 | Astellas Pharma Inc | Results NEW ENZALUTAMIDE DATA IN TRIPLE-NEGATIVE BREAST CANCER PRESENTED AT THE 2015 AMERICAN SOCIETY OF CLINICAL ONCOLOGY ANNUAL MEETING astellas.com ↗
In the 75 Evaluable patients, CBR16 was achieved in 35% (95% CI: 24-46) including six CR/PR (8%). |
| 2015-04-03 | Astellas Pharma Inc | Results ENZALUTAMIDE DEMONSTRATES STATISTICALLY SIGNIFICANT IMPROVEMENT IN PROGRESSION FREE SURVIVAL COMPARED WITH BICALUTAMIDE IN STRIVE TRIAL astellas.com ↗
The study achieved its primary endpoint demonstrating a statistically significant increase in progression-free survival (PFS) for enzalutamide compared with bicalutamide (Hazard Ratio = 0.24; 95% Confidence Interval, 0.18-0.32; p<0.0001). |
| 2015-01-23 | Astellas Pharma Inc | Results ENZALUTAMIDE PHASE 2 TERRAIN TRIAL DEMONSTRATED STATISTICALLY SIGNIFICANT INCREASE IN PFS AS COMPARED TO BICALUTAMIDE IN METASTATIC PROSTATE CANCER astellas.com ↗
Median PFS was 15.7 months in the enzalutamide group compared to 5.8 months in the bicalutamide group. |
| 2014-12-15 | Astellas Pharma Inc | Results DATA PRESENTED FROM PHASE 2 STUDY OF ENZALUTAMIDE IN ADVANCED ANDROGEN-RECEPTOR POSITIVE, TRIPLE-NEGATIVE BREAST CANCER astellas.com ↗
In the 26 Evaluable women, the primary endpoint was achieved in 42% (11 of 26) including 1 partial response in a patient with measurable disease and 1 complete response in a patient with non measurable disease. |
| 2014-12-02 | Astellas Pharma Inc | Regulatory ENZALUTAMIDE (XTANDI) NOW APPROVED IN EUROPE FOR THE TREATMENT OF MEN WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER WHO ARE CHEMOTHERAPY-NAÏVE astellas.com ↗
Tokyo, December 2, 2014 –Astellas Pharma Inc. (TSE: 4503, “Astellas”) today announced that the European Commission (EC) has granted a variation to amend the Marketing Authorisation for enzalutamide (trade name XTANDI). |
| 2014-10-27 | Astellas Pharma Inc | Regulatory XTANDI (ENZALUTAMIDE) CAPSULES RECEIVE POSITIVE CHMP OPINION FOR THE TREATMENT OF MEN WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER WHO ARE CHEMOTHERAPY-NAÏVE astellas.com ↗
Astellas Pharma Europe Ltd. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending a variation to amend the Marketing Authorisation for enzalutamide (trade name XTANDI™). |
| 2014-10-22 | Astellas Pharma Inc | Regulatory Astellas Announces Revision of Package Insert in Japan for XTANDI® (enzalutamide) Capsules, a Prostate Cancer Treatment astellas.com ↗
Also, the items “Side effects” and “Clinical results” of the package insert have been revised. |
| 2014-09-11 | Astellas Pharma Inc | Regulatory U.S. FDA Approves New Indication for the Use of XTANDI® (enzalutamide) Capsules for Patients with Metastatic Castration-Resistant Prostate Cancer astellas.com ↗
the U.S. Food and Drug Administration (FDA) approved a new indication for the use of XTANDI® (enzalutamide) capsules to treat patients with metastatic castration-resistant prostate cancer (CRPC). |
| 2014-05-06 | Astellas Pharma Inc | Regulatory ASTELLAS AND MEDIVATION RECEIVE PRIORITY REVIEW FROM FDA FOR XTANDI® (ENZALUTAMIDE) CAPSULES IN CHEMOTHERAPY-NAIVE ADVANCED PROSTATE CANCER astellas.com ↗
This sNDA application was granted Priority Review designation with a stated FDA Prescription Drug User Fee Act (PDUFA) review date of September 18, 2014. |
| 2014-03-24 | Astellas Pharma Inc | Regulatory Astellas Announces Marketing Approval in Japan for XTANDI® (enzalutamide) Capsules, a Prostate Cancer Treatment astellas.com ↗
Upon receiving this marketing authorization in Japan, Astellas will provide Medivation with a $15 million milestone payment. |
| 2014-03-19 | Astellas Pharma Inc | Regulatory ASTELLAS AND MEDIVATION SUBMIT SUPPLEMENTAL NEW DRUG APPLICATION FOR XTANDI (ENZALUTAMIDE) FOR CHEMOTHERAPY-NAÏVE ADVANCED PROSTATE CANCER astellas.com ↗
Astellas Pharma Inc. (TSE: 4503) and Medivation Inc. (NASDAQ: MDVN) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval of XTANDI® (enzalutamide) capsules for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy. |
| 2014-01-28 | Astellas Pharma Inc | Results MEDIVATION AND ASTELLAS ANNOUNCE FINAL RESULTS FROM THE PHASE 3 PREVAIL TRIAL OF ENZALUTAMIDE IN MEN WITH METASTATIC PROSTATE CANCER PROGRESSING ON ANDROGEN DEPRIVATION THERAPY astellas.com ↗
Treatment with enzalutamide demonstrated a statistically significant overall survival benefit compared with placebo treatment. |
| 2013-10-22 | Astellas Pharma Inc | Results Medivation and Astellas Announce The Phase 3 PREVAIL Trial of Enzalutamide Meets Both Co-Primary Endpoints of Overall Survival and Radiographic Progression-Free Survival in Chemotherapy-Naïve Patients With Advanced Prostate Cancer astellas.com ↗
Patients treated with enzalutamide demonstrated a statistically significant overall survival advantage compared with patients receiving placebo (p<0.0001). |
| 2013-06-03 | Astellas Pharma Inc | Regulatory XTANDI® (Enzalutamide) Capsules Receives Health Canada Approval for Treatment of Metastatic Castration-Resistant Prostate Cancer in Patients Previously Treated With Docetaxel astellas.com ↗
Health Canada has approved XTANDI® (enzalutamide) capsules for the treatment of patients with metastatic castration-resistant prostate cancer in the setting of medical or surgical castration who have received docetaxel therapy. |
| 2013-05-24 | Astellas Pharma Inc | Regulatory Astellas and Medivation Announce Submission of Application for Marketing Approval of Enzalutamide, an Oral Androgen Receptor Inhibitor, in Japan astellas.com ↗
Astellas Pharma Inc. (TSE: 4503) and Medivation, Inc. (NASDAQ: MDVN) today announced that Astellas has submitted an application for marketing approval of enzalutamide (generic name) to the Ministry of Health, Labour and Welfare in Japan for the treatment of prostate cancer. |
| 2013-04-26 | Astellas Pharma Inc | Regulatory POSITIVE CHMP OPINION FOR XTANDITM (ENZALUTAMIDE) IN ADVANCED PROSTATE CANCER1 astellas.com ↗
The CHMP's positive recommendation will be reviewed by the European Commission (EC), which has authority to approve medicines for the European Union. |
| 2011-05-19 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva and OncoGenex to Present Data on Custirsen in Prostate Cancer at the 2011 ASCO Annual Meeting tevapharm.com ↗
The study showed a synergistic effect in combining custirsen and MDV3100, down-regulating androgen receptor levels and suppressing androgen-sensitive prostate cancer cell growth in vitro and in vivo |
All press releases naming this drug 130 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 130 releases opens the full record — a long page | ||
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 350 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Enzalutamide | “The intervention strictly involves continuing the identical Androgen Deprivation Therapy (ADT) and Androgen Receptor Pathway Inhibitor (ARPI) regimen-such as abiraterone,...” NCT07838753 ↗335“This regimen consists of Androgen Deprivation Therapy (ADT) (e.g., Goserelin, Leuprorelin, Triptorelin, or Degarelix) combined with an oral Androgen Receptor (AR) inhibitor...” NCT07389174 ↗ “The drugs to be administered are: prednisone 5 mg orally twice daily, abiraterone 1000 mg orally once daily, enzalutamide 160 mg orally once daily, and cabazitaxel intravenous...” NCT03110588 ↗ “Current systemic therapy is most commonly a second generation androgen pathway inhibitor, including enzalutamide or abiraterone, although other standard agents (e.g. docetaxel,...” NCT03556904 ↗ “Bridging therapy including Anti-AR agents (example, abiraterone, enzalutamide) will be administered orally and radiotherapy, or chemotherapy (example, docetaxel) will be...” NCT05022849 ↗ “Darolutamide is the preferred ARPI for this study; however, patients may receive abiraterone, apalutamide, or enzalutamide at the discretion of their oncologist and based on...” NCT07645326 ↗ “Androgen deprivation with or without docetaxel chemotherapy, Abiraterone, Enzalutamide or any other proven agent) treatment as determined by treating physician (positive control).” NCT03763253 ↗ “Additional therapy following tumor board meeting : new generation hormonal therapy (abiraterone, enzalutamide, apalutamide or other approved) or chemotherapy (docetaxel).” NCT04115007 ↗ “ADT plus only 12 months of ARPI (apalutamide/enzalutamide) with the possibility to resume treatment with ARSI in case of a confirmed PSA rise.” NCT07260435 ↗ “Agents of interest included Abiraterone, Enzalutamide, Pembrolizumab, Ipilimumab, Carboplatin, Docetaxel, and Olaparib as well as combinations” NCT04399876 ↗ “Enzalutamide is a potent androgen receptor signalling inhibitor that blocks several steps in the androgen receptor signalling pathway.” NCT03869762 ↗ |
| Known as | ASP9785 | “A Phase I Open-label Study to Evaluate the Effect of Multiple Doses of MDV3100 (ASP9785) on the Pharmacokinetics of Substrates for CYP2C8, CYP2C9, CYP2C19, and CYP3A4 in...” NCT01911728 ↗ |
| Known as | MDV3100 | “Enzalutamide, formerly known as MDV3100, is a rationally-designed second generation AR inhibitor which functions by blocking several steps in the AR signaling cascade.” NCT01942837 ↗12“Enzalutamide (formerly called MDV3100) targets multiple steps in the androgen-receptor-signaling pathway, the major driver of prostate-cancer growth.” PMID 22894553 ↗ Aug 2012 “Study of Enzalutamide (Formerly MDV3100) as a Neoadjuvant Therapy for Patients Undergoing Prostatectomy for Localized Prostate Cancer” NCT01547299 ↗ “Enzalutamide (MDV3100) 160 mg PO once daily for 6 months” NCT02203695 ↗ |
| Known as | NSC# 766085 | “A Phase II Study of Enzalutamide (NSC# 766085) for Patients With Androgen Receptor Positive Salivary Cancers” NCT02749903 ↗ |
| Known as | Xtandi | “Enzalutamide, sold under the brand name Xtandi, is a nonsteroidal antiandrogen medication which is used in the treatment of prostate cancer.” NCT05726292 ↗7“The ARPI drugs used in this study will be either abiraterone acetate (Zytiga) (plus prednisone/prednisolone) or enzalutamide (Xtandi).” NCT04597125 ↗ “Brand name of darolutamide is Nubeqa; brand name of enzalutamide is Xtandi.” NCT04157088 ↗ “enzalutamide (Xtandi®, "Xtandi is a trademark of Astellas Pharma, Inc." )” NCT02380313 ↗ “Apalutamide [Erleada], darolutamide [Nubeqa], or enzalutamide [Xtandi]” NCT05683964 ↗ “Enzalutamide (Xtandi®) 40 mg capsules or 40 mg and 80 mg tablets” NCT05413421 ↗ |
| Action | Inhibit | “MDV3100 is an androgen-receptor antagonist that blocks androgens from binding to the androgen receptor and prevents nuclear translocation and co-activator recruitment of the...” PMID 20398925 ↗ Apr 2010 |
| Modality | Other / unclassified | “Anti-androgen medication for the treatment of metastatic castration-resistant prostate cancer.” NCT02685397 ↗ |
| Route | Oral | “enzalutamide 160 mg orally once a day” PMID 37142371 ↗ May 2023 |
| Target | AR | “enzalutamide suppresses AR signaling” PMID 24882673 ↗ May 2014 |