EP. 2: FDA Approves FoundationOne Companion Diagnostic to Entrectinib in NSCLC
January 6th 2023The 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. 10: FDA Grants Orphan Drug Designation to LNS8801 for Metastatic Cutaneous Melanoma
January 19th 2023LNS8801 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 Cancer
January 30th 2023The 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.