The FDA granted priority review to four anticancer therapies or combinations for the treatment of various subtypes of lung cancer.
- capmatinib (INC280; Novartis, Incyte), an investigational oral MET inhibitor, for the treatment of patients with advanced non-small cell lung cancer who harbor MET exon 14 skipping mutations;
- the combination of nivolumab (Opdivo, Bristol-Myers Squibb), an anti-PD-1 antibody, and ipilimumab (Yervoy, Bristol-Myers Squibb), an anti-CTLA-4 antibody, for the first-line treatment of patients with metastatic or recurrent NSCLC without EGFR or ALK mutations;
- lurbinectedin (PM1183; PharmaMar, Jazz Pharmaceuticals), an investigational RNA polymerase II inhibitor, for the treatment of small cell lung cancer that relapsed after platinum-based therapy; and
- selpercatinib (Eli Lilly) — formerly known as LOXO-292, an investigational oral agent for cancers that harbor abnormalities in the rearranged during transfection (RET) kinase — for the treatment of advanced RET fusion-positive NSCLC. The agent also received priority review for RET-mutant medullary thyroid cancer and RET fusion-positive thyroid cancer.