- In what could be another first for Keytruda (pembrolizumab), Merck is going after a non-small cell lung cancer (NSCLC) indication. Keytruda became the first FDA-approved immunotherapy cancer drug in September 2014 when it was approved for unresectable melanoma.
- Merck is competing head-on with BMS, which also has an immunotherapy cancer drug, Opdivo (nivolumab). Opdivo is now indicated for treatment of melanoma and BMS is now going after a lung cancer indication.
- Merck is also filing its once-daily combo of grazoprevir and elbasvir for treatment of hep C.
While it's true that Merck got there first with Keytruda and has an aggressive clinical study program in over 30 therapeutic areas, BMS has solid NSCLC data, including data that showed a strong survival advantage in patients with advanced squamous cell NSCLC treated with Opdivo. In fact, the data was so good that the trial was stopped early. Merck is pursuing an indication for NSCLC in patients without ALK or EGFR mutations. Ultimately, most drugs will most likely be approved for the NSCLC indications—and that bodes well for patients.