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Details:
Ayvakyt (avapritinib) is a kinase inhibitor, works by potently and selectively target KIT D816V. It is approved by european commission for the treatment of indolent systemic mastocytosis (ISM).
Lead Product(s): Avapritinib
Therapeutic Area: Immunology Product Name: Ayvakyt
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 13, 2023
Details:
AYVAKYT® (avapritinib) is a kinase inhibitor approved by the European Commission for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN) or mast cell leukemia (MCL).
Lead Product(s): Avapritinib
Therapeutic Area: Immunology Product Name: Ayvakit
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 10, 2023
Details:
Ayvakit (avapritinib) is a FDA approved kinase inhibitor for treatment adults with Indolent Systemic Mastocytosis, ASM, SM-AHN and MCL, also for adults with GIST harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations.
Lead Product(s): Avapritinib
Therapeutic Area: Immunology Product Name: Ayvakit
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 22, 2023
Details:
Ayvakit (avapritinib) is a kinase inhibitor approved by the FDA for the treatment of adults with Advanced SM, ASM, SM-AHN and MCL, and adults with unresectable or metastatic GIST harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations.
Lead Product(s): Avapritinib
Therapeutic Area: Immunology Product Name: Ayvakit
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 14, 2023
Details:
Ayvakit (avapritinib) is a kinase inhibitor approved by the FDA for the treatment of adults with Advanced SM, ASM, SM-AHN and MCL, and adults with unresectable or metastatic GIST harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations.
Lead Product(s): Avapritinib
Therapeutic Area: Immunology Product Name: Ayvakit
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 03, 2023
Details:
Ayvakit (avapritinib) is a kinase inhibitor approved by the FDA for the treatment of adults with Advanced SM, ASM, SM-AHN and MCL, and adults with unresectable or metastatic GIST harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations.
Lead Product(s): Avapritinib
Therapeutic Area: Immunology Product Name: Ayvakit
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 23, 2023
Details:
Ayvakit (avapritinib) is a FDA approved kinase inhibitor for treatment adults with Advanced SM, ASM, SM-AHN and MCL, also for adults with GIST harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations.
Lead Product(s): Avapritinib
Therapeutic Area: Immunology Product Name: Ayakit
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 11, 2022
Details:
AYVAKIT (avapritinib) is a kinase inhibitor approved by the FDA for the treatment of adults with Advanced SM, including aggressive SM (ASM), SM with an associated hematological neoplasm (SM-AHN) and mast cell leukemia (MCL).
Lead Product(s): Avapritinib
Therapeutic Area: Immunology Product Name: Ayvakit
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 22, 2022
Details:
Key highlights include oral PATHFINDER trial, which reinforces transformative impact of AYVAKIT (avapritinib) as first-line treatment in advanced SM, and also highlights survival benefits after nearly four years of patient follow-up in advanced SM.
Lead Product(s): Avapritinib
Therapeutic Area: Immunology Product Name: Ayvakit
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 03, 2022
Details:
The trial, which was designed to assess AYVAKIT (avapritinib) plus best available care versus placebo plus best available care (control arm), achieved its primary endpoint with a highly significant difference in the mean change in total symptom score at 24 weeks (p=0.003).
Lead Product(s): Avapritinib
Therapeutic Area: Immunology Product Name: Ayvakit
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 17, 2022
Details:
Blueprints' significant accomplishments to date and add strategic financial partners who are aligned with the company's growth ambitions and confidence in the anticipated commercial opportunity and launch performance of AYVAKIT/AYVAKYT (avapritinib) and GAVRETO (pralsetinib).
Lead Product(s): Avapritinib
Therapeutic Area: Oncology Product Name: Ayvakit
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sixth Street
Deal Size: $250.0 million Upfront Cash: $250.0 million
Deal Type: Collaboration June 30, 2022
Details:
Primary endpoint of PIONEER trial of AYVAKIT (Avapritinib) in non-advanced SM to be updated to mean change in total symptom score, previously a key secondary endpoint, based on U.S. FDA recommendation.
Lead Product(s): Avapritinib
Therapeutic Area: Immunology Product Name: Ayvakit
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 09, 2022
Details:
The EC decision follows positive opinion by CHMP and is based on results from Phase 1 EXPLORER trial and Phase 2 PATHFINDER trial, in which AYVAKYT showed durable clinical efficacy in advanced SM patients across all disease subtypes.
Lead Product(s): Avapritinib
Therapeutic Area: Immunology Product Name: Ayvakit
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 25, 2022
Details:
AYVAKYT (avapritinib) is a kinase inhibitor approved by the European Commission for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumors (GIST) harboring the PDGFRA D842V mutation.
Lead Product(s): Avapritinib
Therapeutic Area: Oncology Product Name: Ayvakit
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 28, 2022
Details:
AYVAKIT® (avapritinib), a kinase inhibitor approved by the FDA for the treatment, showed robust efficacy and safety datasets in advanced systemic mastocytosis.
Lead Product(s): Avapritinib
Therapeutic Area: Hematology Product Name: Ayvakit
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 06, 2021
Details:
The FDA granted full approval to AYVAKIT for adults with advanced SM based on data from the Phase 1 EXPLORER trial and Phase 2 PATHFINDER trial. AYVAKIT showed durable clinical efficacy in advanced SM patients across disease subtypes and regardless of prior therapy.
Lead Product(s): Avapritinib
Therapeutic Area: Hematology Product Name: Ayvakit
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 16, 2021
Details:
AYVAKIT is China’s first approved precision therapy for patients with PDGFRA Exon 18 Mutant Gastrointestinal Stromal Tumor.
Lead Product(s): Avapritinib
Therapeutic Area: Oncology Product Name: Ayvakit
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 31, 2021
Details:
AYVAKIT is a potent and selective inhibitor of D816V mutant KIT, the primary driver of SM, and is being developed to treat advanced and non-advanced forms of the disease.
Lead Product(s): Avapritinib
Therapeutic Area: Oncology Product Name: Ayvakit
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 17, 2020
Details:
The CHMP based its opinion on efficacy results from the Phase 1 NAVIGATOR trial as well as combined safety results from the NAVIGATOR and Phase 3 VOYAGER trials.
Lead Product(s): Avapritinib
Therapeutic Area: Oncology Product Name: Ayvakit
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 24, 2020
Details:
If approved by the European Commission, avapritinib would be the first treatment in the EU indicated for patients with PDGFRA D842V mutant GIST and would be commercialized under the brand name AYVAKYT®.
Lead Product(s): Avapritinib
Therapeutic Area: Oncology Product Name: Ayvakit
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 24, 2020
Details:
The Lancet Oncology published data from the NAVIGATOR clinical trial showed an unprecedented overall survival (OS) rate and a well-tolerated safety profile for AYVAKIT™ (avapritinib) in patients with advanced PDGFRA D842V mutant gastrointestinal stromal tumor (GIST).
Lead Product(s): Avapritinib
Therapeutic Area: Oncology Product Name: Ayvakit
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 29, 2020
Details:
Updated PIONEER trial data in patients with indolent SM showed response rate of 60% for avapritinib versus 0% for placebo at 24 weeks, with response defined as ≥30% reduction in total symptom score.
Lead Product(s): Avapritinib
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 06, 2020
Details:
VOYAGER did not meet the primary endpoint of an improvement in progression-free survival for avapritinib versus regorafenib in patients with third- or fourth-line GIST.
Lead Product(s): Avapritinib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 28, 2020
Details:
Avapritinib has demonstrated outstanding antitumor activity and a well-tolerated safety profile in advanced PDGFRA exon 18 mutant GIST and fourth-line GIST.
Lead Product(s): Avapritinib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 22, 2020
Details:
Data demonstrated an ORR of 84% with most adverse events reported as Grade 1 or 2 for avapritinib in patients with advanced GIST harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations.
Lead Product(s): Avapritinib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 27, 2020
Details:
AYVAKIT™ (avapritinib) is the first precision therapy approved for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumours (GISTs) and advanced systemic mastocytosis (ASM).
Lead Product(s): Avapritinib
Therapeutic Area: Oncology Product Name: Ayvakit
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Blueprint Medicines
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 27, 2020
Details:
Blueprint Medicines conducted Phase 2 PIONEER trial of avapritinib in patients with indolent systemic mastocytosis.
Lead Product(s): Avapritinib
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 24, 2020
Details:
NCCN guidelines now include avapritinib as recommended treatment for PDGFRA exon 18 mutant GIST and fourth-line GIST.
Lead Product(s): Avapritinib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 06, 2020
Details:
With nationwide distribution of AYVAKIT, PANTHERx establishes a formidable presence in the precision oncology space.
Lead Product(s): Avapritinib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Blueprint Medicines
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership January 17, 2020
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