PDGFRA

QIAGEN receives FDA approval for companion diagnostic to Blueprint Medicines’ AYVAKIT® (avapritinib) in gastrointestinal stromal tumors

Retrieved on: 
Monday, August 7, 2023
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The kit is the first platelet-derived growth factor receptor alpha (PDGFRA) assay to receive FDA approval as a companion diagnostic.

Key Points: 
  • The kit is the first platelet-derived growth factor receptor alpha (PDGFRA) assay to receive FDA approval as a companion diagnostic.
  • QIAGEN and Blueprint Medicines collaboratively developed the PDGFRA companion diagnostic assay.
  • QIAGEN is a pioneer in precision medicine and the leader in collaborating with pharmaceutical and biotechnology companies to develop companion diagnostics.
  • Furthermore, QIAGEN has recently announced a series of collaborations with Neuron23 and Helix to develop companion diagnostics in disease areas outside oncology.

Ascentage Pharma's Novel Drug Olverembatinib Recommended for a Breakthrough Therapy Designation in China for the Treatment of SDH-Deficient GIST, the Second BTD for the Drug

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Wednesday, May 31, 2023
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To date, olverembatinib has been granted two Priority Review Designations that underscored the drug's promising therapeutic utility.

Key Points: 
  • To date, olverembatinib has been granted two Priority Review Designations that underscored the drug's promising therapeutic utility.
  • Drugs that have been granted BTDs are prioritized by the CDE in communications and exchange, and in receiving guidance to advance the drug development progress.
  • Furthermore, BTD-designated drugs will be eligible for Priority Review status and conditional approvals upon submission of a New Drug Application (NDA).
  • Antitumor activity of olverembatinib (HQP1351) in patients (pts) with tyrosine kinase inhibitor (TKI)–resistant succinate dehydrogenase (SDH)–deficient gastrointestinal stromal tumor (GIST).

Blueprint Medicines Reports Clinical Data Highlighting Leadership in Developing Targeted Treatment Options for Patients with Systemic Mastocytosis

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Sunday, December 11, 2022
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CAMBRIDGE, Mass., Dec. 11, 2022 /PRNewswire/ -- Blueprint Medicines Corporation (NASDAQ: BPMC) today announced AYVAKIT® (avapritinib) data showing high, durable response rates and prolonged overall survival (OS) in patients with advanced systemic mastocytosis (Advanced SM), including SM with an associated hematological neoplasm (SM-AHN). The findings are being reported in two presentations, including an oral presentation featuring updated follow-up from treatment-naïve patients in the PATHFINDER trial, at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition in New Orleans. AYVAKIT is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with Advanced SM.

Key Points: 
  • AYVAKIT is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with Advanced SM.
  • "AYVAKIT has become the standard of care treatment for advanced systemic mastocytosis in the U.S., with a growing number of patients receiving the therapy early in the course of their disease.
  • This breadth of data highlights strong clinical execution and reflects our leadership in developing a portfolio of targeted treatment options designed to address the medical needs of patients with SM."
  • Blueprint Medicines plans to present data from Part 1 of the HARBOR trial at a medical congress in 2023.

Blueprint Medicines Submits Supplemental New Drug Application to FDA for AYVAKIT® (avapritinib) for the Treatment of Indolent Systemic Mastocytosis

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Wednesday, November 23, 2022
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CAMBRIDGE, Mass., Nov. 22, 2022 /PRNewswire/ -- Blueprint Medicines Corporation (NASDAQ: BPMC) today announced the submission of a supplemental new drug application to the U.S. Food and Drug Administration (FDA) for AYVAKIT® (avapritinib) for the treatment of adults with indolent systemic mastocytosis (SM). AYVAKIT was designed to potently and selectively inhibit D816V mutant KIT, the underlying cause of SM in about 95 percent of cases.

Key Points: 
  • CAMBRIDGE, Mass., Nov. 22, 2022 /PRNewswire/ --Blueprint Medicines Corporation(NASDAQ:BPMC) today announced the submission of a supplemental new drug application to theU.S.
  • Food and Drug Administration(FDA) for AYVAKIT (avapritinib) for the treatment of adults with indolent systemic mastocytosis (SM).
  • The FDA has granted breakthrough therapy designation to AYVAKIT for the treatment of moderate to severe indolent SM.
  • Blueprint Medicines, AYVAKIT, AYVAKYTand associated logos are trademarks ofBlueprint Medicines Corporation.

Deciphera Pharmaceuticals, Inc. Announces Publication of INTRIGUE Phase 3 Clinical Study Results in Journal of Clinical Oncology

Retrieved on: 
Wednesday, August 10, 2022
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These full Phase 3 INTRIGUE study results continue to deepen our understanding of QINLOCK and its place in the GIST treatment landscape, said Matthew L. Sherman, M.D., Chief Medical Officer of Deciphera.

Key Points: 
  • These full Phase 3 INTRIGUE study results continue to deepen our understanding of QINLOCK and its place in the GIST treatment landscape, said Matthew L. Sherman, M.D., Chief Medical Officer of Deciphera.
  • INTRIGUE is an international, multi-center study conducted in 122 active sites across 22 countries, where 453 patients with second-line GIST were randomized to receive ripretinib (n=226) or sunitinib (n=227).
  • Patient reported outcome measures also showed a more favorable tolerability profile for patients receiving ripretinib compared to patients receiving sunitinib.
  • Clinical activity of ripretinib in patients with advanced gastrointestinal stromal tumor harboring heterogenous KIT/PDGFRA mutations in the phase 3 INVICTUS study.

Personalis to Present Data Demonstrating Breadth of NeXT Platform for Oncology at AACR Annual Meeting 2022

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Wednesday, March 23, 2022
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Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, announced it is presenting new data in scientific posters at the American Association for Cancer Research (AACR) Annual Meeting 2022 , which will be held in-person and online, April 8-13, 2022.

Key Points: 
  • Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, announced it is presenting new data in scientific posters at the American Association for Cancer Research (AACR) Annual Meeting 2022 , which will be held in-person and online, April 8-13, 2022.
  • However, studies typically utilize assays limited to a small set of genes that may miss biologically important and clinically actionable mutations.
  • The NeXT Liquid Biopsy platform enables the identification of somatic variants in liquid biopsy samples, following interventions such as surgery and treatment therapies.
  • To enable cancer sequencing, Personalis' Clinical Laboratory was built with a focus on clinical accuracy, quality, big data, scale, and efficiency.

Nature Medicine Publishes Results from Two Registration Studies of AYVAKIT® (avapritinib) Showing Sustained Benefits in Patients with Advanced Systemic Mastocytosis

Retrieved on: 
Monday, December 6, 2021
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AYVAKIT showed broad activity across all advanced SM subtypes, including SM with an associated hematological neoplasm (SM-AHN).

Key Points: 
  • AYVAKIT showed broad activity across all advanced SM subtypes, including SM with an associated hematological neoplasm (SM-AHN).
  • Overall, 10 percent of patients in the EXPLORER trial and 5 percent of patients in the PATHFINDER trial discontinued AYVAKIT due to treatment-related AEs.
  • Blueprint Medicines is developing AYVAKIT globally for the treatment of advanced and non-advanced SM.
  • A minority of patients have advanced SM, which encompasses a group of high-risk SM subtypes including ASM, SM-AHN and MCL.

DGAP-News: Deciphera Receives European Commission Approval of QINLOCK(R) for the Treatment of Fourth-Line Gastrointestinal Stromal Tumor

Retrieved on: 
Monday, November 22, 2021
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Deciphera Press Release: Deciphera Announces Australian Therapeutic Goods Administration's Approval of QINLOCK(TM) (ripretinib) for the Treatment of Fourth-Line Gastrointestinal Stromal Tumor [online] July 14, 2020.

Key Points: 
  • Deciphera Press Release: Deciphera Announces Australian Therapeutic Goods Administration's Approval of QINLOCK(TM) (ripretinib) for the Treatment of Fourth-Line Gastrointestinal Stromal Tumor [online] July 14, 2020.
  • Deciphera Press Release: Deciphera Announces Health Canada's Authorization of QINLOCK(TM) (ripretinib) for the Treatment of Fourth-Line Gastrointestinal Stromal Tumor [online] June 22, 2020.
  • Deciphera Press Release: Deciphera Announces Approval of QINLOCK(R) in Switzerland for the Treatment of Fourth-Line Gastrointestinal Stromal Tumor [online] October 12, 2020.
  • Deciphera Press Release: FDA Grants Full Approval of Deciphera Pharmaceuticals' QINLOCK(TM) (ripretinib) for the Treatment of Fourth-Line Gastrointestinal Stromal Tumor [online] May 15, 2020.

Bayer Pharmaceuticals and The Life Raft Group, a Non-Profit, Announce Innovative Collaboration to Accelerate Cancer Research for GIST Patients

Retrieved on: 
Monday, November 8, 2021
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Bayer Pharmaceuticals, working with The Life Raft Group (LRG), announced today that they have extended a research collaboration to broaden access to comprehensive genomic testing for Gastrointestinal Stromal Tumor (GIST) patients.

Key Points: 
  • Bayer Pharmaceuticals, working with The Life Raft Group (LRG), announced today that they have extended a research collaboration to broaden access to comprehensive genomic testing for Gastrointestinal Stromal Tumor (GIST) patients.
  • There are different types of comprehensive genomic testing: the most common tests are basic mutational testing and advanced next-generation sequencing.
  • The results can help healthcare providers match patients with available treatment options or clinical trials.
  • Results from this testing collaboration will help us understand more traits and patterns within GIST that will help us with our aim of accelerating GIST cancer research.

Ayvakit Patent, Sales & Clinical Trials Market Insight Report 2021-2028 - ResearchAndMarkets.com

Retrieved on: 
Wednesday, November 3, 2021
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The "Ayvakit Patent, Sales & Clinical Trials Insight 2028" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Ayvakit Patent, Sales & Clinical Trials Insight 2028" report has been added to ResearchAndMarkets.com's offering.
  • Keeping in mind the sales in previous years and ongoing clinical trials, the report analyzes that the global sales will reach US$ 1 Billion by 2028.
  • The rapid approval of drugs from this class will have a negative impact on the growth of Ayvakit market.
  • Ayvakit Patent, Sales & Clinical Trials Insight 2028 Report Analysis & Data Highlights: