FDA, Drug Manufacturer Pull Keytruda’s Indication for Small Cell Lung Cancer

Merck – the manufacturer of Keytruda (pembrolizumab) – is pulling the immunotherapy drug’s indication for patients with metastatic small cell lung cancer whose disease progressed on or after platinum-based chemotherapy and one or more prior line of therapy.

Merck – the manufacturer of Keytruda (pembrolizumab) – is pulling the immunotherapy drug’s indication for patients with metastatic small cell lung cancer whose disease progressed on or after platinum-based chemotherapy and one or more prior line of therapy.

If patients with previously treated small cell lung cancer are being treated with Keytruda, they should talk with their healthcare providers about best next steps.

Merck consulted with the Food and Drug Administration (FDA) on the decision, as part of an evaluation of drugs that were granted accelerated approvals that have not yet met marketing follow-up endpoints.

This indication of Keytruda was granted an accelerated approval in June 2019 based on findings from cohort G of the KEYNOTE-158 trial and cohort C1 of the KEYNOTE-028 trial. Results showed that the PD-1 inhibitor had a promising tumor response rate and durability of response.

However, for the drug to stay approved, it had to meet overall survival (OS) and progression-free survival (PFS) endpoints. Updated findings of the phase 3 confirmatory KEYNOTE-604 trial indicated that Keytruda met the PFS endpoint, but not the primary endpoint for OS.

While the indication for Keytruda in pretreated metastatic small cell lung cancer was pulled, it does not affect the drug’s approval status for other cancer types.

“The accelerated pathways created by the FDA have been integral to the remarkable progress in oncology care over the past five years and have helped many cancer patients with advanced disease, including small cell lung cancer, access new treatments,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer at Merck Research Laboratories, said in a statement.

Moving forward, researchers will continue to study Keytruda in small cell lung cancer and other cancer types.

“Keytruda remains a foundational treatment for certain patients with metastatic non-small cell lung cancer. We will continue to rigorously evaluate the benefits of Keytruda in small cell lung cancer and other types of cancer, in pursuit of Merck’s mission to save and improve lives,” Baynes said.

For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here.