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Details:
FoundationOne®CDx to be used as a companion diagnostic for ALUNBRIG® (brigatinib), which is currently FDA-approved for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer as detected by an FDA-approved test.
Lead Product(s): Brigatinib
Therapeutic Area: Oncology Product Name: Alunbrig
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 01, 2021
Details:
Takeda has received approval from the Japanese Ministry of Health, Labour and Welfare to manufacture and market “ALUNBRIG® Tablets 30 mg, 90 mg" as a first and second-line therapy for patients with unresectable, advanced or recurrent ALK+ NSCLC.
Lead Product(s): Brigatinib
Therapeutic Area: Oncology Product Name: Alunbrig
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 22, 2021
Details:
Long-term results from the Phase 3 ALTA 1L trial established alunbrig as a superior first-line treatment compared to Crizotinib for People with ALK+ Metastatic NSCLC, including those with Brain Metastases.
Lead Product(s): Brigatinib
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 May 22, 2020
Details:
The sNDA is based on results from the Phase 3 ALTA-1L trial, which is evaluating the safety and efficacy of ALUNBRIG in patients with ALK+ locally advanced or metastatic NSCLC.
Lead Product(s): Brigatinib
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 24, 2020
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