In the last week, the FDA made several announcements that exemplify the accelerating pace at which new treatments for lung cancer are reaching patients. These advancements underscore the importance of and need for continued research that affect quality of life and survival rates of people living with lung cancer. 

Breakthrough therapy designation to mobocertinib for NSCLC patients with EGFR exon 20 insertion mutations

The FDA granted breakthrough therapy designation to mobocertinib for treatment of certain patients with metastatic non-small cell lung cancer. The designation applies to use of mobocertinib (TAK-788, Takeda) by patients with EGFR exon 20 insertion mutations whose disease progressed on or after platinum-based chemotherapy. Importantly, there are currently no approved therapies designed to treat this specific form of NSCLC. The expedited path for development and approval of this drug represents an important advancement for this underserved population of lung cancer patients. Read more

New dosing regimen for pembrolizumab

The FDA granted accelerated approval to a new dosing regimen for pembrolizumab that showed efficacy and safety to take once every six weeks instead of three. This approval will provide important flexibility in some patients’ treatment schedules who are receiving immunotherapy. Read more

Accelerated approval to capmatinib for metastatic NSCLC patients with MET exon 14 skipping mutations

FDA granted accelerated approval for capmatinib for the treatment of metastatic NSCLC patients with a confirmed MET exon 14 skipping mutation. Capmatinib had previously received orphan drug and breakthrough therapy designations, and it is the first approved therapy that specifically targets MET exon 14 mutated advanced NSCLC. Read more

Selpercatinib approved for lung cancer with RET gene mutation

The FDA has approved selpercatinib for patients with metastatic RET fusion-positive NSCLC. Selpercatinib was previously granted orphan drug designation and represents the first therapy that specifically targets RET-driven cancers. Read more

Nivolumab + ipilimumab combo approved for first-line treatment of metastatic NSCLC

The FDA has approved the combination of nivolumab (OPDIVO) plus ipilimumab (YERVOY) as first-line treatment for patients with metastatic non-small cell lung cancer with PD-L1 without the EGFR or ALK mutations. Read more