EP. 2: FDA Approves FoundationOne Companion Diagnostic to Entrectinib in NSCLCJanuary 6th 2023
The FDA has approved the liquid biopsy next-generation sequencing-based test FoundationOne Liquid CDx in companion with entrectinib for patients with non–small cell lung cancer with a ROS1 mutation in their tumor.
EP. 3: BT8009 Receives Fast Track Designation for Advanced Urothelial CancerJanuary 6th 2023
A Nectin-4–directed drug received FDA Fast Track Designation based on preclinical and clinical data showing potential efficacy and safety in patients with locally advanced or metastatic urothelial cancer.
EP. 4: FDA Accepts BLA and Grants Priority Review for Glofitamab in R/R LBCLJanuary 6th 2023
Based on data from a phase 1/2 study, a biologics license application has been accepted for glofitimab and the product has been granted priority review to for relapsed/refractory large B-cell lymphoma.
EP. 8: FDA Approves Tucatinib Plus Trastuzumab for RAS Wild-Type, HER2+ mCRCJanuary 19th 2023
MOUNTAINEER study results have wowed the FDA, leading to an accelerated FDA approval of tucatinib plus trastuzumab as RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer treatment.
EP. 10: FDA Grants Orphan Drug Designation to LNS8801 for Metastatic Cutaneous MelanomaJanuary 19th 2023
LNS8801 has proven to be safe, well-tolerated, and demonstrated clinical benefit in patients with advanced cancers. Now, the FDA has granted the agent orphan drug designation for metastatic cutaneous melanoma.
EP. 17: FDA Okays Guardant360 Test as CDx for Elacestrant in ESR1-mutated Breast CancerJanuary 30th 2023
The Guardant360 CDx, which will identify patients with advanced or metastatic breast cancer who have ESR1 mutations and may benefit from elacestrant, is the fifth test to be approved by the FDA and first for patients with breast cancer.
EP. 18: FDA Grants Breakthrough Therapy Designation to Pimicotinib for TGCTJanuary 31st 2023
Based on results from a phase 1b study of pimicotinib showing the therapys efficacy in patients with tenosynovial giant cell tumor, the agent has gained breakthrough therapy designation from the FDA.