Article

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

Author(s):

The Food and Drug Administration granted a priority review to Keytruda (pembrolizumab) for the third-line treatment of patients with advanced small cell lung cancer (SCLC).

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.

Newsletter

Stay up to date on cancer updates, research and education

Related Videos
Building long-term trust with providers can help patients with MPNs feel supported, encourage them to speak up and navigate care with confidence.
The field of radiation oncology has advanced in brain cancer treatment with precise therapeutic approaches including proton and carbon therapy.
Image of Dr. Doug
Image of doctor.
Image of Dr. Kelly
Image of Dr. Boffa.
2 experts are featured in this series.
2 experts are featured in this series.
Immune Therapy Expands Melanoma Treatment to More Patients
Bladder preservation for bladder cancer requires balancing clinical factors and patient health with a personalized treatment plan.
Related Content