Drugs / Ripretinib
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed gastrointestinal stromal tumor 6 milestones | |||||
| Filed | Japan (PMDA) | — | gastrointestinal stromal tumor | 2026-03-26 | “Application submitted for manufacturing and marketing approval of ripretinib in Japan for the indication of “gastrointestinal stromal tumor that has progressed following cancer...” deciphera.com ↗ |
| Filed | China (NMPA) | QINLOCK | gastrointestinal stromal tumor | 2020-07-20 | “Announced, along with Zai Lab Limited, that the China National Medical Products Administration (NMPA) accepted its New Drug Application (NDA) for ripretinib” deciphera.com ↗ “today announced that the China National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for ripretinib” deciphera.com ↗ “In July 2020, the NMPA accepted the NDA submission of QINLOCK for the treatment of fourth-line GIST.” zailaboratory.com ↗ |
| Filed | US (FDA) | — | gastrointestinal stromal tumor | 2020-03-09 | “the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) seeking approval for ripretinib” deciphera.com ↗ |
| Filed | Other | — | gastrointestinal stromal tumor | 2020-01-13 | “Ripretinib Marketing Applications Submitted to Health Canada and Australia’s Therapeutic Goods Administration for Patients with Advanced GIST” deciphera.com ↗ |
| Filed | US (FDA) | — | gastrointestinal stromal tumor | 2019-12-16 | “we submitted our first New Drug Application (NDA) to the FDA for ripretinib in advanced gastrointestinal stromal tumors (GIST)” deciphera.com ↗ “today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ripretinib” deciphera.com ↗ |
| Filed | EU (EMA) | QINLOCK | gastrointestinal stromal tumor | — | “Submitted and received validation of a Marketing Authorisation Application (MAA) for QINLOCK in fourth-line gastrointestinal stromal tumor (GIST).” deciphera.com ↗ “Received validation from the European Medicines Agency (EMA) for the Marketing Authorisation Application for QINLOCK in fourth-line GIST.” deciphera.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Qinlock | — | 2021-11-18 | europa.eu ↗ |
| Approved | US (FDA) | QINLOCK | — | 2020-05-15 | fda.gov ↗ |
Trials 10
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT07618377 | Jul 2026 → Feb 2028 expected | gastrointestinal stromal tumor | Ono Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1 | NCT04530981 | Sep 2021 → Nov 2023 | gastrointestinal stromal tumor | Deciphera Pharmaceuticals, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02571036 | Nov 2015 → Apr 2022 | gastrointestinal stromal tumor, systemic mastocytosis | Deciphera Pharmaceuticals, LLC | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05080621 | Nov 2021 → Nov 2025 | gastrointestinal stromal tumor | Deciphera Pharmaceuticals, LLC | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 22 trials | ||||||
| Phase 2 | NCT04633122 | Nov 2020 → Jul 2022 | gastrointestinal stromal tumor | Zai Lab (Shanghai) Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT04282980 | Apr 2020 → Feb 2021 | gastrointestinal stromal tumor | Zai Lab (Shanghai) Co., Ltd. | Completed | No outcome recorded |
| Phase 32 trials · 1 missed | ||||||
| Phase 3 | NCT05734105 | Dec 2023 → Dec 2027 expected | gastrointestinal stromal tumor | Deciphera Pharmaceuticals, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03673501 | Feb 2019 → Sep 2021 overdue | gastrointestinal stromal tumor | Deciphera Pharmaceuticals, LLC | Active not recruiting | Missed primary |
| Phase not applicable1 trial | ||||||
| — | NCT05132738 | Aug 2021 → Nov 2023 | gastrointestinal stromal tumor | RenJi Hospital | Unknown | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04148092 | — | gastrointestinal stromal tumor | Deciphera Pharmaceuticals, LLC | Approved for marketing | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 1/2 | NCT05957367 Background | Sep 2023 → Mar 2027 expected | gastrointestinal stromal tumor | Deciphera Pharmaceuticals, LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT03353753 Comparator | Feb 2018 → May 2019 | gastrointestinal stromal tumor | Deciphera Pharmaceuticals, LLC | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 56
| Date | Issuer | Release |
|---|---|---|
| 2026-03-26 | Ono Pharmaceutical Co., Ltd. | Regulatory Ono Pharma Submits an Application for Approval of Ripretinib (DCC-2618) in Patients with Advanced Gastrointestinal Stromal Tumor in Japan ono-pharma.com ↗ |
| 2026-03-26 | Deciphera Pharmaceuticals, LLC | Regulatory Ono Pharma Submits an Application for Approval of Ripretinib (DCC-2618) in Patients with Advanced Gastrointestinal Stromal Tumor in Japan deciphera.com ↗
Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President: Toichi Takino; “Ono”) today announced that Ono submitted an application for the manufacturing and marketing approval of ripretinib (DCC-2618), developed by Deciphera Pharmaceuticals, Inc. (“Deciphera”), for the indication of “gastrointestinal stromal tumor that has progressed following cancer chemotherapy.” |
| 2024-11-27 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces the Inclusion of AUGTYRO® (repotrectinib) for ROS1+ NSCLC and Other Updates in China’s National Reimbursement Drug List zailaboratory.com ↗
QINLOCK® (ripretinib) is renewed for advanced gastrointestinal stromal tumor (GIST) patients who have received prior treatment with three or more kinase inhibitors in the all-comer setting. |
| 2024-01-18 | Deciphera Pharmaceuticals, LLC | Results Deciphera Pharmaceuticals Presents Long-Term Follow-Up Results from INTRIGUE Phase 3 Clinical Study in Second-Line GIST Patients at the 2024 American Society of Clinical Oncology Gastrointestinal Cancers Symposium deciphera.com ↗
“These long-term clinical results demonstrate that the overall survival rate was similar for both QINLOCK and sunitinib, and that treatment with QINLOCK continued to show a favorable safety profile compared to treatment with sunitinib,” said Dr. Zalcberg. |
| 2024-01-05 | Deciphera Pharmaceuticals, LLC | Results Deciphera Pharmaceuticals Announces Nature Medicine Publication of Results from Exploratory ctDNA Analysis from INTRIGUE Phase 3 Study Demonstrating Substantial Clinical Benefit of QINLOCK® in 2L GIST Patients with Mutations in KIT Exon 11 and 17/18 deciphera.com ↗
today announced that Nature Medicine has published results from a circulating tumor DNA (ctDNA) analysis of the INTRIGUE Phase 3 study of QINLOCK (ripretinib) in GIST patients with mutations in KIT exon 11 and 17/18 only previously treated with imatinib. |
| 2023-06-01 | Zai Lab (Shanghai) Co., Ltd. | Results Zai Lab to Highlight New Data from its Oncology Pipeline at 2023 ASCO Annual Meeting zailaboratory.com ↗
The long-term follow up results continue to support the clinically meaningful benefit in PFS |
| 2023-05-25 | Deciphera Pharmaceuticals, LLC | Results Deciphera Pharmaceuticals to Present Data from INTRIGUE Phase 3 Study of QINLOCK® (ripretinib) and Trial-in-Progress Poster for INSIGHT Pivotal Phase 3 Study of QINLOCK® at the 2023 American Society of Clinical Oncology Annual Meeting deciphera.com ↗
In the all-patient intent-to-treat population, overall survival was 35.5 months in the QINLOCK arm and 30.9 months in the sunitinib arm. |
| 2023-03-14 | Deciphera Pharmaceuticals, LLC | Regulatory Deciphera Pharmaceuticals Announces QINLOCK® Included in NCCN Guidelines® for the Treatment of Second-Line GIST Patients and FDA Grants Breakthrough Therapy Designation for QINLOCK in Second-Line GIST Patients with Mutations in KIT Exon 11 and 17/18 deciphera.com ↗ |
| 2023-01-24 | Deciphera Pharmaceuticals, LLC | Results Deciphera Pharmaceuticals Presents Results from ctDNA Analysis of INTRIGUE Phase 3 Clinical Study at the American Society of Clinical Oncology Plenary Series Session deciphera.com ↗
We are pleased with the exploratory analysis, which showed that QINLOCK provided clinically meaningful benefit for second-line GIST patients based on the mutational drivers of their disease. |
| 2023-01-18 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces Inclusion of QINLOCK® (ripretinib) and NUZYRA® (omadacycline) in China’s National Reimbursement Drug List zailaboratory.com ↗
The inclusion of both QINLOCK and NUZYRA in the NRDL is another opportunity for us to achieve that mission. |
| 2023-01-03 | Deciphera Pharmaceuticals, LLC | Results Deciphera Pharmaceuticals Announces Results from ctDNA Analysis from INTRIGUE Phase 3 Clinical Study Demonstrating Substantial Clinical Benefit of QINLOCK® in Second-Line GIST Patients with Mutations in KIT Exon 11 and 17/18 Only deciphera.com ↗ |
| 2022-08-10 | Deciphera Pharmaceuticals, LLC | Results Deciphera Pharmaceuticals, Inc. Announces Publication of INTRIGUE Phase 3 Clinical Study Results in Journal of Clinical Oncology deciphera.com ↗
Although QINLOCK did not offer a statistically significant improvement in progression-free survival (PFS) compared to sunitinib, QINLOCK showed meaningful clinical activity with fewer Grade 3/4 treatment-emergent adverse events (TEAEs) and improved tolerability. |
| 2022-01-24 | Deciphera Pharmaceuticals, LLC | Results Deciphera Pharmaceuticals Presents Results from the INTRIGUE Phase 3 Clinical Study at the American Society of Clinical Oncology Plenary Series Session deciphera.com ↗
Efficacy Observed with QINLOCK® was Comparable to Sunitinib with a More Favorable Safety and Tolerability Profile in GIST Patients Previously Treated with Imatinib |
| 2021-12-21 | Deciphera Pharmaceuticals, LLC | Regulatory Deciphera Announces Approval of QINLOCK® in the United Kingdom for the Treatment of Fourth-Line Gastrointestinal Stromal Tumor deciphera.com ↗ |
| 2021-11-22 | Deciphera Pharmaceuticals, LLC | Regulatory Deciphera Receives European Commission Approval of QINLOCK® for the Treatment of Fourth-Line Gastrointestinal Stromal Tumor deciphera.com ↗ |
| 2021-11-05 | Deciphera Pharmaceuticals, LLC | Results Deciphera Pharmaceuticals Announces Top-Line Results from the INTRIGUE Phase 3 Clinical Study deciphera.com ↗
The study did not meet the primary endpoint of improved progression-free survival (PFS) compared with the standard of care sunitinib. |
| 2021-10-12 | Deciphera Pharmaceuticals, LLC | Regulatory Deciphera Announces Approval of QINLOCK® in Switzerland for the Treatment of Fourth-Line Gastrointestinal Stromal Tumor deciphera.com ↗ |
| 2021-09-17 | Deciphera Pharmaceuticals, LLC | Regulatory Deciphera Announces Positive CHMP Opinion for QINLOCK® for the Treatment of Fourth-line Gastrointestinal Stromal Tumor deciphera.com ↗
We are delighted that the CHMP has adopted a positive opinion for QINLOCK, which could lead to Deciphera's regulatory approval in the European Union, |
| 2021-09-01 | Zai Lab (Shanghai) Co., Ltd. | Regulatory QINLOCK® (Ripretinib) Approved in Taiwan for Treatment of Advanced Gastrointestinal Stromal Tumors (GIST) zailaboratory.com ↗
Zai Lab (NASDAQ: ZLAB; HKEX: 9688), an innovative commercial-stage biopharmaceutical company, today announced that the Taiwan Food and Drug Administration has approved its New Drug Application (NDA) for QINLOCK® (ripretinib) for the treatment of adult patients with advanced gastrointestinal stromal tumors (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib. |
| 2021-06-04 | Deciphera Pharmaceuticals, LLC | Results Deciphera Pharmaceuticals Presents Data from QINLOCK® and Rebastinib Programs at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting deciphera.com ↗
Exploratory Analysis of the INVICTUS Phase 3 Study Showed QINLOCK Dose Escalation After Disease Progression Provided Substantial Clinical Benefit in Advanced GIST |
| 2021-03-31 | Zai Lab (Shanghai) Co., Ltd. | Regulatory China NMPA Approves QINLOCK® (Ripretinib) for Treatment of Advanced Gastrointestinal Stromal Tumors (GIST) zailaboratory.com ↗
China NMPA Approves QINLOCK® (Ripretinib) for Treatment of Advanced Gastrointestinal Stromal Tumors (GIST) |
| 2020-11-11 | Deciphera Pharmaceuticals, LLC | Results Deciphera Presents Data from QINLOCK® (Ripretinib) Program at the Connective Tissue Oncology Society (CTOS) 2020 Virtual Annual Meeting deciphera.com ↗
Results from an Exploratory Analysis of the Phase 3 INVICTUS Study in Fourth-line GIST Demonstrate the Broad Clinical Activity of QINLOCK Across Mutation Sub-groups |
| 2020-09-18 | Deciphera Pharmaceuticals, LLC | Results Deciphera Presents Data from QINLOCK™ (Ripretinib) Program in Patients with Gastrointestinal Stromal Tumor at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 deciphera.com ↗
Data presented today demonstrates impressive long-term, follow-up results from our INVICTUS study, which support QINLOCK’s efficacy in fourth-line GIST. |
| 2020-08-17 | Deciphera Pharmaceuticals, LLC | Results Deciphera Announces Publication of QINLOCK™ (ripretinib) Phase 1 Study Results in Patients with Gastrointestinal Stromal Tumor in Journal of Clinical Oncology deciphera.com ↗
Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), today announced that the Journal of Clinical Oncology has published results from its Phase 1 study of QINLOCK, the Company’s switch-control tyrosine kinase inhibitor, in patients with second-line through fourth-line plus gastrointestinal stromal tumor (GIST). |
| 2020-08-04 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces NDA for Ripretinib Granted Priority Review by China’s NMPA zailaboratory.com ↗
Zai Lab Limited (NASDAQ: ZLAB), an innovative commercial stage biopharmaceutical company, today announced that the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) has granted priority review status to the New Drug Application (NDA) for ripretinib for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. |
| 2020-07-30 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Ripretinib Becomes the First Unregistered Drug in Mainland China Approved for the Named Patient Program Outside the Pilot Zone of Hainan Province zailaboratory.com ↗
Zai Lab today announced ripretinib has been approved by Health Commission and Medical Products Administration of Hainan Province as the first drug in mainland China used under the special Named Patient Program (NPP). |
| 2020-07-20 | Deciphera Pharmaceuticals, LLC | Regulatory China NMPA Accepts NDA Submission of Ripretinib for Advanced Gastrointestinal Stromal Tumor deciphera.com ↗ |
| 2020-07-20 | Zai Lab (Shanghai) Co., Ltd. | Regulatory China NMPA Accepts NDA Submission of Ripretinib for Advanced Gastrointestinal Stromal Tumor zailaboratory.com ↗
China NMPA Accepts NDA Submission of Ripretinib for Advanced Gastrointestinal Stromal Tumor |
| 2020-07-14 | Deciphera Pharmaceuticals, LLC | Regulatory Deciphera Announces Australian Therapeutic Goods Administration’s Approval of QINLOCK™ (ripretinib) for the Treatment of Fourth-Line Gastrointestinal Stromal Tumor deciphera.com ↗ |
| 2020-07-02 | Deciphera Pharmaceuticals, LLC | Results Deciphera Announces Presentation of Analysis of Crossover Population from the INVICTUS Phase 3 Study of QINLOCK™ (ripretinib) in Patients with Fourth-Line Advanced GIST deciphera.com ↗
The data presented showed that patients who crossed over to the open-label extension to receive treatment with QINLOCK demonstrated a median PFS of 4.6 months and an OS benefit of 11.6 months. |
| 2020-06-22 | Deciphera Pharmaceuticals, LLC | Regulatory Deciphera Announces Health Canada’s Authorization of QINLOCK™ (ripretinib) for the Treatment of Fourth-Line Gastrointestinal Stromal Tumor deciphera.com ↗
Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) today announced that Health Canada has authorized QINLOCK™ (ripretinib), a switch-control tyrosine kinase inhibitor, for sale in Canada for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with imatinib, sunitinib, and regorafenib. |
| 2020-06-08 | Deciphera Pharmaceuticals, LLC | Results Deciphera Announces Publication of the INVICTUS Pivotal Phase 3 Study of QINLOCK™ (ripretinib) in The Lancet Oncology deciphera.com ↗
Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) today announced that The Lancet Oncology has published results from the INVICTUS pivotal Phase 3 study of QINLOCK in patients with fourth-line gastrointestinal stromal tumor (GIST). |
| 2020-05-29 | Deciphera Pharmaceuticals, LLC | Results Deciphera Pharmaceuticals Announces Presentations of Positive Patient Reported Outcomes Results from INVICTUS Phase 3 Study of QINLOCK™ (ripretinib) in Patients with Fourth-Line Advanced GIST at the ASCO 2020 Virtual Scientific Program deciphera.com ↗
Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) today announced the presentation of quality of life and certain safety results from the INVICTUS pivotal Phase 3 study evaluating QINLOCK™ (ripretinib) in adult patients with fourth-line advanced gastrointestinal stromal tumor (GIST). |
| 2020-05-15 | Deciphera Pharmaceuticals, LLC | Regulatory FDA Grants Full Approval of Deciphera Pharmaceuticals’ QINLOCK™ (ripretinib) for the Treatment of Fourth-Line Gastrointestinal Stromal Tumor deciphera.com ↗
Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) today announced the U.S. Food and Drug Administration (FDA) has approved QINLOCK™ (ripretinib) for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. |
| 2020-02-12 | Deciphera Pharmaceuticals, LLC | Regulatory Deciphera Pharmaceuticals Announces U.S. Food and Drug Administration Acceptance of New Drug Application and Priority Review for Ripretinib in Patients with Advanced Gastrointestinal Stromal Tumors deciphera.com ↗
Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review its New Drug Application (NDA) seeking approval for ripretinib, the Company’s investigational broad-spectrum KIT and PDGFRα inhibitor, for the treatment of patients with advanced gastrointestinal stromal tumors (GIST). |
| 2020-01-13 | Deciphera Pharmaceuticals, LLC | Regulatory Deciphera Pharmaceuticals Provides Corporate Update and Highlights Key 2020 Milestones deciphera.com ↗
The Company announced today that two additional marketing applications have been submitted for ripretinib as part of the U.S. Food and Drug Administration’s (FDA) Project Orbis pilot program. |
| 2019-12-16 | Deciphera Pharmaceuticals, LLC | Regulatory Deciphera Pharmaceuticals Announces Submission of New Drug Application to U.S. FDA for Ripretinib in Patients with Advanced Gastrointestinal Stromal Tumors deciphera.com ↗
Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ripretinib, the Company’s investigational broad-spectrum KIT and PDGFRα inhibitor, for the treatment of patients with advanced GIST who have received prior treatment with imatinib, sunitinib and regorafenib. |
| 2019-11-04 | Deciphera Pharmaceuticals, LLC | Regulatory Deciphera Pharmaceuticals, Inc. Announces Third Quarter 2019 Financial Results deciphera.com ↗
FDA granted Breakthrough Therapy Designation (BTD) for ripretinib for the treatment of patients with advanced GIST who have received prior treatment with imatinib |
| 2019-10-29 | Deciphera Pharmaceuticals, LLC | Results Deciphera Pharmaceuticals Presents Updated Data from Ripretinib and DCC-3014 Programs at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics deciphera.com ↗
Of note, we believe ripretinib continues to demonstrate strong clinical benefit in post-imatinib GIST patients, particularly in the second-line setting. |
| 2019-09-30 | Deciphera Pharmaceuticals, LLC | Results Deciphera Pharmaceuticals Announces Late-Breaking Oral Presentation at the ESMO 2019 Congress Demonstrating Positive Results from INVICTUS Pivotal Phase 3 Study of Ripretinib in Patients with Advanced Gastrointestinal Stromal Tumors deciphera.com ↗
Today’s presentation featured new data as well as top-line results previously announced by the Company in August 2019. |
| 2019-08-13 | Deciphera Pharmaceuticals, LLC | Results Deciphera Pharmaceuticals Reports Positive Updated Phase 1 Data for Ripretinib in Gastrointestinal Stromal Tumors deciphera.com ↗
Median Progression Free Survival (mPFS) Sustained across All Cohorts |
| 2019-08-13 | Deciphera Pharmaceuticals, LLC | Results Deciphera Pharmaceuticals Announces Positive Top-line Results from INVICTUS Pivotal Phase 3 Clinical Study of Ripretinib in Patients with Advanced Gastrointestinal Stromal Tumors deciphera.com ↗
INVICTUS Achieved Primary Endpoint, Ripretinib Significantly Improved Progression Free Survival (PFS) Versus Placebo in Patients with Fourth-line and Fourth-line Plus GIST |
| 2018-10-19 | Deciphera Pharmaceuticals, LLC | Results Deciphera Pharmaceuticals Reports Updated Preliminary Phase 1 Clinical Study Results with DCC-2618 at the European Society of Medical Oncology (ESMO) 2018 Congress deciphera.com ↗
We are extremely pleased with the preliminary results presented today that we believe demonstrate the potential of DCC-2618 to provide improved, durable clinical benefit for GIST patients from second-line through fourth-line-plus |
| 2018-06-02 | Deciphera Pharmaceuticals, LLC | Results Deciphera Pharmaceuticals Reports Updated Interim Phase 1 Clinical Study Results with DCC-2618 at The 2018 American Society of Clinical Oncology Annual Meeting (ASCO) and Provides Additional Clinical and Regulatory Updates on DCC-2618 deciphera.com ↗
Interim Results with DCC-2618 Demonstrate Robust Clinical Activity in Heavily Pretreated GIST Patients, Including Patients Previously Treated with the Investigational Agent avapritinib (BLU-285) |
| 2018-04-16 | Deciphera Pharmaceuticals, LLC | Results Deciphera Pharmaceuticals, Inc. Reports Updated Data from Ongoing Phase 1 Clinical Trial of DCC-2618 at 2018 American Association for Cancer Research (AACR) Annual Meeting deciphera.com ↗
today announced the presentation of updated data from its ongoing Phase 1 clinical trial of DCC-2618 |
| 2017-11-28 | Deciphera Pharmaceuticals, LLC | Regulatory Deciphera Pharmaceuticals, Inc. Announces Orphan Drug Designation from the EMA for DCC-2618 for the Treatment of Gastrointestinal Stromal Tumors deciphera.com ↗
WALTHAM, Mass., Nov. 28, 2017 (GLOBE NEWSWIRE) -- Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, today announced that the European Medicines Agency (EMA) has granted orphan drug designation (ODD) to DCC-2618, the Company’s pan-KIT and PDGFRα inhibitor, for the treatment of gastrointestinal stromal tumors (GIST). |
| 2017-11-20 | Deciphera Pharmaceuticals, LLC | Results Deciphera Pharmaceuticals Reports Data from Ongoing Phase 1 Clinical Study of DCC-2618 at the 22nd Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology deciphera.com ↗
Out of four evaluable patients diagnosed with glioblastoma multiforme (GBM), one achieved a durable partial response per Response Assessment in Neuro-Oncology (RANO) criteria and sustained 94% tumor reduction after 84 weeks (cycle 23, day 1) on therapy. |
| 2017-11-10 | Deciphera Pharmaceuticals, LLC | Results Deciphera Pharmaceuticals, Inc. Reports Data Analysis from the Ongoing Phase 1 Clinical Trial of DCC-2618 at the Annual Meeting of The Connective Tissue Oncology Society deciphera.com ↗
Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, today announced the presentation of data analysis from its ongoing Phase 1 clinical trial of DCC-2618, the Company’s pan-KIT and PDGFRα inhibitor. |
| 2017-11-06 | Deciphera Pharmaceuticals, LLC | Results Deciphera Pharmaceuticals, Inc. to Report Clinical Data with DCC-2618 at the Upcoming 22nd Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology deciphera.com ↗
Title: DCC-2618, a novel pan-KIT and PDGFRa kinase switch control inhibitor, shows encouraging signal in a patient (pt) with glioblastoma (GBM) |
| 2017-09-11 | Deciphera Pharmaceuticals, LLC | Results Deciphera Pharmaceuticals Reports Updated Data from Ongoing Phase 1 Clinical Study of DCC-2618 at the European Society of Medical Oncology 2017 Congress deciphera.com ↗
The data showed that in heavily pretreated patients with GIST, treatment with DCC-2618 at >100 mg daily resulted in disease control rates of 76% at 12 weeks and 57% at 24 weeks. |
| 2017-09-05 | Deciphera Pharmaceuticals, LLC | Regulatory Deciphera Pharmaceuticals Announces FDA Orphan Drug Designation for DCC-2618 for the Treatment of Glioblastoma Multiforme and Anaplastic Astrocytoma deciphera.com ↗
today announced that the U.S. Food and Drug Administration (“FDA”) has granted orphan drug designation to DCC-2618, the Company’s pan-KIT and PDGFRα inhibitor, for the treatment of glioblastoma multiforme and anaplastic astrocytoma. |
| 2017-08-31 | Deciphera Pharmaceuticals, LLC | Results Deciphera Pharmaceuticals to Present Updated Data from Ongoing Phase 1 Study of DCC-2618 at the 2017 European Society for Medical Clinical Oncology Annual Congress deciphera.com ↗
DCC-2618 produced reductions in the mutation allele frequencies for KIT across exons 9, 11, 13, 14, 17 and 18, demonstrating a broad spectrum of activity that included reductions in patients with KIT mutations known to confer resistance to imatinib. |
| 2017-06-05 | Deciphera Pharmaceuticals, LLC | Results Deciphera Pharmaceuticals Reports Updated Phase 1 Clinical Study Results with DCC-2618 at 2017 American Society of Clinical Oncology Annual Meeting deciphera.com ↗
Results from the completed dose escalation stage of the Phase 1 trial with DCC-2618 demonstrated encouraging disease control with prolonged stable disease and objective responses in heavily pretreated patients with gastrointestinal stromal tumors (GIST). |
| 2017-04-03 | Deciphera Pharmaceuticals, LLC | Results Translational Research Results Confirm The Broad Activity of DCC-2618 in GIST Patients With Difficult to Treat Drug Resistant KIT Mutations deciphera.com ↗ |
| 2016-12-01 | Deciphera Pharmaceuticals, LLC | Results Deciphera Pharmaceuticals Reports Encouraging Clinical Results with DCC-2618 in Genetically-defined Cancers with Drug Resistant Mutations deciphera.com ↗
The clinical results were described in a late-breaking oral presentation at the 28th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics taking place November 29 to December 2, 2016 in Munich, Germany. |
| 2016-10-31 | Deciphera Pharmaceuticals, LLC | Results Deciphera Pharmaceuticals to Present Clinical Data on Tumor Targeted Advanced Kinase Inhibitors at 28th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics deciphera.com ↗
DCC-2618, a pan KIT and PDGFR switch control inhibitor, achieves proof-of-concept in a first-in-human study |
All press releases naming this drug 68 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 15 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ripretinib | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04530981 ↗ |
| Known as | DCC-2618 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04282980 ↗ |
| Known as | Qinlock | “The results of this study led to ripretinib, also known by the brand name Qinlock®, being approved in the USA by regulators as the only medication for adults with advanced GIST...” PMID 34661454 ↗ Oct 2021 |
| Action | Inhibit | “inhibits KIT and PDGFRA signaling.” PMID 36514034 ↗ Dec 2022 |
| Modality | Small molecule | — CHEMBL4216467 ↗ |
| Route | Oral | “DCC-2618 tablets in escalating dose cohorts given orally BID (twice daily) every 12 hours or once daily (QD) for repeated 28-day cycles.” NCT02571036 ↗ |
| Target | KIT | “inhibits KIT and PDGFRA signaling.” PMID 36514034 ↗ Dec 2022 |
| Target | PDGFRA | “inhibits KIT and PDGFRA signaling.” PMID 36514034 ↗ Dec 2022 |