FDA Grants Priority Review to Pembrolizumab for Advanced SCLC

The FDA granted a priority review to a supplemental Biologics License Application (sBLA) for pembrolizumab (Keytruda) to be used as a monotherapy treatment for patients with advanced small cell lung cancer (SCLC) who experienced progression on 2 or more prior lines of therapy, according to Merck, the manufacturer of the PD-1 inhibitor.

With the priority review, the FDA will expedite the review of the drug in this setting, and the agency is set to make a decision on its approval on June 17, 2019.

“There is a significant need for new treatment options for small cell lung cancer, which has a five-year survival rate of only 6 percent overall,” said Jonathan Cheng, MD, vice president, oncology clinical research, Merck Research Laboratories, in a statement.

The priority review was based off 2 trials. The phase II KEYNOTE-158 trial examined the efficacy of pembrolizumab in patients with metastatic or unresectable solid tumors — including SCLC. The phase Ib KEYNOTE-028 trial 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.

Historically, checkpoint inhibitors like pembrolizumab have not been as successful in the treatment of patients with SCLC as they have in patients with non-small cell lung cancer. However, recent results — such as those seen in the KEYNOTE trials – are growing excitement for this small subset of patients with lung cancer. In August, the FDA approved nivolumab (Opdivo) for the treatment of patients with SCLC whose disease progressed on platinum-based chemotherapy and 1 other line of therapy.

“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,” Cheng said.