Non-Small Cell Lung Cancer

The FDA has granted Priority Review to tepotinib for metastatic NSCLC whose tumors have a mutation that leads to METex14 skipping.

The FDA has approved ramucirumab in combination with erlotinib, for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 substitution mutations.

The Food and Drug Administration has approved the combination of nivolumab and ipilimumab and 2 cycles of platinum-doublet chemotherapy, for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer, with no EGFR or ALK genomic tumor aberrations.

The approval was based on data from the phase 3 IMpower110 study that compared the efficacy and safety of atezolizumab monotherapy to platinum-based chemotherapy in PD-L1-selected, chemotherapy-naive patients with stage IV NSCLC without ALK or EGFR mutations.

The FDA has approved the combination of Opdivo plus Yervoy for the first-line treatment of adult patients with metastatic non-small cell lung cancer whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

The FDA has granted accelerated approval to capmatinib for the treatment of adults with metastatic NSCLC with a mutation that leads to MET exon 14 skipping.

The FDA has granted Breakthrough Therapy designation to mobocertinib (TAK-788; Takeda) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.

The phase 3 trial evaluating cemiplimab as a potential first-line treatment in patients with locally advanced or metastatic non-small cell lung cancer was stopped early due to “highly significant improvement” in overall survival.