Drugs / Talazoparib
Talazoparib
also known as
BMN673 · Talzenna · MDV3800 · BMN 673ts · LT-673 · PF-06944076 · TALAZOPARIB (BMN 673) · Talazoparib 1 MG Oral Capsule [Talzenna] · +2 more
Small molecule targets PARP1, PARP2 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 12 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed castration-resistant prostate carcinoma 2 milestones | |||||
| Filed | US (FDA) | TALZENNA | castration-resistant prostate carcinoma | 2026-07-22 | “A supplemental New Drug Application (sNDA) for TALZENNA plus XTANDI in mAPMN/S is currently under Priority Review by the U.S. Food and Drug Administration (FDA).” pfizer.com ↗ “the U.S. Food and Drug Administration (FDA) accepted for Priority Review a supplemental New Drug Application (sNDA) for TALZENNA ® (talazoparib)” pfizer.com ↗ |
| Filed | EU (EMA) | TALZENNA | castration-resistant prostate carcinoma | 2023-06-20 | “A marketing authorization application (MAA) for the TALZENNA and XTANDI combination has been accepted for review by the European Medicines Agency.” pfizer.com ↗ “The use of TALZENNA plus XTANDI in HRR gene-mutated mCSPC is also under review by the European Medicines Agency.” pfizer.com ↗ |
| Filed progesterone-receptor positive breast cancer 2 milestones | |||||
| Filed | EU (EMA) | — | progesterone-receptor positive breast cancer | 2018-06-07 | “The European Medicines Agency has also accepted the Marketing Authorization Application for talazoparib in this patient population.” pfizer.com ↗ “European Medicines Agency (EMA) acceptance of Pfizer's submission of a Marketing Authorization Application (MAA) for talazoparib.” biomarin.com ↗ |
| Filed | US (FDA) | — | progesterone-receptor positive breast cancer | 2018-06-07 | “the U.S. Food and Drug Administration accepted for filing and granted Priority Review designation to the company’s New Drug Application for talazoparib.” pfizer.com ↗ “U.S. Food and Drug Administration (FDA) acceptance of Pfizer's New Drug Application (NDA) submission for talazoparib” biomarin.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (6) | US (FDA) | TALZENNA | — | 2019-09-24 – 2025-06-12 | fda.gov ↗ |
| Approved | EU (EMA) | Talzenna | — | 2019-06-20 | europa.eu ↗ |
| Approved | US (FDA) | TALZENNA | — | 2018-10-16 | fda.gov ↗ |
Trials 104 · started per year
today
US approved 2018
EU approved 2019
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News releases announcing trial results or a regulatory action · 28
| 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 ↗ |
| 2026-05-30 | 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). |
| 2026-04-21 | 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. |
| 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) |
| 2024-10-10 | Pfizer | Results Pfizer’s TALZENNA® in Combination with XTANDI® Prolongs Overall Survival in Phase 3 TALAPRO-2 Trial pfizer.com ↗ |
| 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 |
| 2023-06-20 | 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) |
| 2023-02-16 | 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). |
| 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. |
| 2022-06-21 | Zenith Epigenetics | Results Zenith Epigenetics Triple Negative Breast Cancer Clinical Data Highlighted in an Oral Discussion at the American Society of Clinical Oncology Conference (ASCO) zenithepigenetics.com ↗
This combination is active with a manageable safety profile and warrants continued clinical evaluation |
| 2020-07-29 | Zenith Epigenetics | Results Zenith Epigenetics Advances ZEN-3694 in Multiple Cancer Programs zenithepigenetics.com ↗
Clinical data to date shows that the combination is active and well tolerated. |
| 2019-12-19 | Zenith Epigenetics | Results Zenith Epigenetics Announces Clinical Advancement of ZEN-3694 zenithepigenetics.com ↗
The TNBC collaboration study, combining ZEN-3694 with Pfizer’s talazoparib, a poly ADP ribose polymerase inhibitor (PARPi), is progressing well with clinical activity in some patients dosed to date. |
| 2019-06-21 | Pfizer | Regulatory European Commission Approves TALZENNA® (talazoparib) for Patients with Inherited (Germline) BRCA-Mutated Locally Advanced or Metastatic Breast Cancer pfizer.com ↗
“Today’s approval of TALZENNA for certain patients with advanced-stage breast cancer and an inherited BRCA mutation is the latest example of our successful precision medicine approach to drug development,” said Andreas Penk, M.D., Regional President, Oncology International Developed Markets at Pfizer. |
| 2019-04-26 | Pfizer | Regulatory Pfizer Receives Positive CHMP Opinion for TALZENNA® (talazoparib) for Patients with Inherited (Germline) BRCA-Mutated Locally Advanced or Metastatic Breast Cancer pfizer.com ↗
The positive CHMP opinion of TALZENNA follows the medicine’s approval by the U.S. Food and Drug Administration (FDA) in October 2018. |
| 2019-03-19 | Merck KGaA, Darmstadt, Germany | Results Merck KGaA, Darmstadt, Germany, and Pfizer Announce Discontinuation of Phase III JAVELIN Ovarian PARP 100 Trial in Previously Untreated Advanced Ovarian Cancer prnewswire.com ↗
The decision to discontinue the JAVELIN Ovarian PARP 100 trial was not made for safety reasons. |
| 2019-03-19 | Pfizer | Results Merck KGaA, Darmstadt, Germany, and Pfizer Announce Discontinuation of Phase III JAVELIN Ovarian PARP 100 Trial in Previously Untreated Advanced Ovarian Cancer pfizer.com ↗
The alliance has notified health authorities and trial investigators of the decision to discontinue the trial. |
| 2018-10-16 | Pfizer | Regulatory U.S. FDA Approves TALZENNA® (talazoparib) pfizer.com ↗
Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration approved TALZENNA® (talazoparib). |
| 2018-06-07 | Pfizer | Regulatory U.S. FDA and European Medicines Agency Accept Regulatory Submissions for Review of Talazoparib for Metastatic Breast Cancer Patients with an Inherited BRCA Mutation pfizer.com ↗
Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration accepted for filing and granted Priority Review designation to the company’s New Drug Application for talazoparib. |
| 2017-12-08 | Pfizer | Results Talazoparib Significantly Extends Progression-Free Survival in Phase 3 EMBRACA Trial of Patients with Metastatic Breast Cancer pfizer.com ↗
Median PFS was 8.6 months (95% CI: 7.2, 9.3) for patients treated with talazoparib and 5.6 months (95% CI: 4.2, 6.7) for those treated with chemotherapy [HR: 0.54 (95% CI: 0.41, 0.71), p<0.0001]. |
| 2017-06-03 | Pfizer | Results Pfizer Presents Final Phase 2 Data on Investigational PARP Inhibitor Talazoparib in Patients with Germline BRCA-Positive Advanced Breast Cancer pfizer.com ↗
Pfizer Inc. (NYSE:PFE) today announced Phase 2 data showing that its investigational, dual-mechanism poly ADP ribose polymerase (PARP) inhibitor, talazoparib, demonstrated anti-tumor activity in patients with germline (inherited) BRCA1/2-positive (gBRCA+) advanced breast cancer. |
| 2015-07-20 | BioMarin Pharmaceutical | Results BioMarin Provides Program Update for Talazoparib in Metastatic Breast Cancer biomarin.com ↗
The company announced that the ABRAZO Phase 2 trial has met the study's protocol-specified threshold for documented tumor reduction (using the RECIST response rate criteria) in order to warrant expanding enrollment in the study from 70 to 140 patients. |
| 2013-10-20 | BioMarin Pharmaceutical | Results Five Data Presentations on BioMarin’s BMN 673 PARP Inhibitor at the 2013 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics biomarin.com ↗
The research as reported on the poster concluded that BMN 673 was approximately 100-fold more potent than olaparib and rucaparib at trapping PARP, making it the most |
| 2013-09-29 | BioMarin Pharmaceutical | Results BioMarin Provides Updated Phase 1/2 Data on BMN 673 in Breast Cancer at the European Cancer Congress 2013 biomarin.com ↗
In addition, there were 5 patients with stable disease lasting at least 24 weeks for an overall clinical benefit response rate at this dose of 86% (12/14). |
| 2013-07-25 | BioMarin Pharmaceutical | Results BioMarin Provides BMN 673 Program Update biomarin.com ↗
As of July 24, the RECIST response rate from the ongoing trial is nine out of 18 breast cancer patients, or 50 percent, including one confirmed complete response. |
| 2013-06-03 | BioMarin Pharmaceutical | Results BioMarin Provides Preliminary Data on Ongoing Phase 1/2 Trial for BMN 673 for the Treatment of Solid Tumors at 2013 American Society of Clinical Oncology Annual Meeting biomarin.com ↗
BMN 673 has exhibited substantial single-agent anti-tumor activity in deleterious germline BRCA ovarian and breast cancers in the trial. |
| 2010-12-02 | BioMarin Pharmaceutical | Regulatory MHRA Completes Review of CTA and Issues Notice of Acceptance for BMN 673 for Genetically-Defined Cancers biomarin.com ↗
has issued a notice of acceptance for BMN 673 for genetically-defined cancers. |
All press releases naming this drug 39 releases
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 109 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Talazoparib | “Participants will receive standard of care PARPi (Olaparib or Talazoparib) therapy in Step 2 and Step 3.” NCT05826964 ↗98“the PARP inhibitor, talazoparib, in patients with advanced triple negative breast cancer” PMID 40471518 ↗ Jun 2025 “Available drugs include olaparib, fluzoparib, pamiparib, talazoparib ect.” NCT05406999 ↗ |
| Known as | BMN 673ts | ChEMBL registry synonym — accepted as the source's own label CHEMBL3137320 ↗ |
| Known as | BMN673 | “The purpose of this open-label, 2:1 randomized phase III trial is to compare the safety and efficacy of talazoparib (also known as BMN 673) versus protocol-specific physician's...” NCT01945775 ↗11“The purpose of this 2-stage, 2-cohort Phase 2 trial is to evaluate the safety and efficacy of talazoparib (also known as BMN 673) in subjects with locally advanced or...” NCT02034916 ↗ “The new experimental drug is called talazoparib (also known as BMN-673), and it is not approved by the Federal Drug Administration (FDA).” NCT02878785 ↗ “Talazoparib (formerly MDV3800 and BMN673) is an oral small molecule, selective inhibitor of PARP-1 and PARP-2.” NCT03964532 ↗ |
| Known as | LT-673 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3137320 ↗ |
| Known as | MDV3800 | “Pharmacodynamic effects of the PARP inhibitor talazoparib (MDV3800, BMN 673) in patients with BRCA-mutated advanced solid tumors.” PMID 38010394 ↗ Nov 20231“Talazoparib (formerly MDV3800 and BMN673) is an oral small molecule, selective inhibitor of PARP-1 and PARP-2.” NCT03964532 ↗ |
| Known as | PF-06944076 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3137320 ↗ |
| Known as | TALAZOPARIB (BMN 673) | ChEMBL registry synonym — accepted as the source's own label CHEMBL3137320 ↗ |
| Known as | Talazoparib 1 MG Oral Capsule [Talzenna] | “Talazoparib 1 MG Oral Capsule [Talzenna]” NCT06193525 ↗ |
| Known as | Talazoparib tosilate | ChEMBL registry synonym — accepted as the source's own label CHEMBL3137320 ↗ |
| Known as | Talazoparib Tosylate | “Drug: Talazoparib Tosylate” NCT04173507 ↗ |
| Known as | Talzenna | “This arm of the Strata PATH trial will assess the clinical benefit of Talzenna® (talazoparib) in patients with advanced solid tumors harboring deep deletions or deleterious...” NCT05097599 ↗3“The purpose of this study is to evaluate how effective the study drugs, nivolumab (also known as Opdivo®) and talazoparib (also known as Talzenna®) are when given as a...” NCT04187833 ↗ “This is an open label, non randomised, investigator-initiated Phase II study of single agent talazoparib (Talzenna®) in metastatic triple negative breast cancer patients with...” NCT05288127 ↗ “Talazoparib 1 MG [Talzenna]” NCT05319249 ↗ |
| Action | Inhibit | “Poly [ADP-ribose] polymerase-1 inhibitor” CHEMBL3137320 ↗ |
| Modality | Small molecule | “Talazoparib (formerly MDV3800 and BMN673) is an oral small molecule” NCT03964532 ↗ |
| Route | Oral | “Orally Administered Talazoparib” NCT01286987 ↗ |
| Target | PARP1 | “Poly [ADP-ribose] polymerase-1 inhibitor” CHEMBL3137320 ↗ |
| Target | PARP2 | “Poly [ADP-ribose] polymerase 2 inhibitor” CHEMBL3137320 ↗ |