New FDA Approvals: FDA Approves Additional Indication for FoundationOne CDx | Jan. 13, 2022
-
Jan 13, 2022
Dec. 8: The FDA gave another approval to Foundation Medicine, Inc.’s FoundationOne CDx as a companion diagnostic for current and future BRAF inhibitors used to treat melanoma, including monotherapies targeting BRAF V600E and BRAF/MEK inhibitor combination therapies targeting BRAF V600E or V600K mutations. The agency first approved the test on Nov. 30, 2017.
Dec. 9: The FDA granted premarket approval to Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic to help identify people with non-small cell lung cancer whose tumors have epidermal growth factor receptor (EGFR) exon 20-insertion mutations who may be candidates for treatment with Rybrevant (amivantamab-vmjw) from Janssen Biotech, Inc., a Johnson & Johnson company. The agency initially approved the test on June 22, 2017.
Read more
© 2024 MMIT
The Latest
Meet Our Reporters
Meet Our Reporters
GAIN THERAPEUTIC AREA-SPECIFIC INTEL TO DRIVE ACCESS FOR YOUR BRAND
Sign up for publications to get unmatched business intelligence delivered to your inbox.