Category: FDA Approvals

The FDA on May 28, 2021 granted accelerated approval to LUMAKRAS®, a RAS GTPase family inhibitor, for adult patients with KRAS G12C mutated locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC), as determined by an FDA approved test, who have received at least one prior systemic therapy. LUMAKRAS® is a product of Amgen, Inc.

The FDA on May 21, 2021 granted accelerated approval to RYBREVANT® for adult patients with locally advanced or metastatic Non-Small Cell Lung Cancer, with EGFR exon 20 insertion mutations, that progressed on or after platinum-based chemotherapy. RYBREVANT® is a product of Janssen Biotech, Inc.