Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Brigatinib
Therapeutic Area : Oncology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Foundation Medicine's FoundationOne®CDx Gets Approval as a Companion Diagnostic for ALUNBRIG
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 a...
Brand Name : Alunbrig
Molecule Type : Small molecule
Upfront Cash : Not Applicable
July 01, 2021
Lead Product(s) : Brigatinib
Therapeutic Area : Oncology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Brigatinib
Therapeutic Area : Oncology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Alunbrig
Molecule Type : Small molecule
Upfront Cash : Not Applicable
January 22, 2021
Lead Product(s) : Brigatinib
Therapeutic Area : Oncology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Brigatinib
Therapeutic Area : Oncology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 22, 2020
Lead Product(s) : Brigatinib
Therapeutic Area : Oncology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Brigatinib
Therapeutic Area : Oncology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Takeda Announces U.S. FDA Grants Priority Review for Supplemental New Drug Application for ALUNBRIG
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.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
February 24, 2020
Lead Product(s) : Brigatinib
Therapeutic Area : Oncology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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