FDA Grants Priority Review to Keytruda for Third-Line Treatment of Small Cell Lung Cancer

The Food and Drug Administration (FDA) granted a priority review to Keytruda (pembrolizumab) for the third-line treatment of patients with advanced small cell lung cancer (SCLC) whose disease has progressed after two or more lines of prior therapy, according to Merck, the anti-PD-1 agent’s manufacturer.

“There is a significant need for new treatment options for small cell lung cancer, which has a five-year survival rate of only six percent overall,” Jonathan Cheng, M.D., vice president of oncology clinical research at Merck Research Laboratories, said in a press release. “Keytruda has already been established as an important treatment option for many patients with advanced non-small cell lung cancer and this acceptance provides an opportunity to potentially benefit even more patients.”

The supplemental biologic license application is based on data from the phase 2 KEYNOTE-158 and Phase 1b KEYNOTE-028 trials.

KEYNOTE-158 examined the efficacy of Keytruda in patients with metastatic or unresectable solid tumors — including SCLC. Meanwhile, KEYNOTE-028 assessed the safety and efficacy of the immunotherapy agent in patients with incurable, advanced, biomarker-positive solid tumors that have not responded to current therapy or for which current therapy is not appropriate

The agency is set to make a decision by June 17, 2019.