FDA News

Four regimens receive priority review for lung cancer indications

The FDA granted priority review to four anticancer therapies or combinations for the treatment of various subtypes of lung cancer.

These include:

  • 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.

The FDA granted priority review to four anticancer therapies or combinations for the treatment of various subtypes of lung cancer.

These include:

  • 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.