Keytruda Earns Priority Review as Monotherapy in NSCLC

September 17, 2018

Last week, the FDA granted priority review to a new supplemental Biologics License Application for pembrolizumab (Keytruda) as a monotherapy for first-line treatment of locally advanced or metastatic nonsquamous or squamous non–small cell lung cancer (NSCLC) in patients whose tumors express PD-L1 without EGFR or ALK mutations.

Last week, the FDA granted priority review to a new supplemental Biologics License Application (sBLA) for pembrolizumab (Keytruda) as a monotherapy for first-line treatment of locally advanced or metastatic nonsquamous or squamous non—small cell lung cancer (NSCLC) in patients whose tumors express PD-L1 without EGFR or ALK mutations.

Lung cancer is the leading cause of cancer death worldwide, responsible for more deaths than colon, breast, and prostate cancers combined. NSCLC is the most common type of lung cancer, accounting for about 85% of all cases.

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The application is based on data from the phase 3 KEYNOTE-042 trial, 1 of 5 phase 3 clinical trials investigating pembrolizumab in NSCLC to determine if it demonstrates a significant improvement in overall survival.

“Keytruda is already a foundation for the treatment of metastatic non-small cell lung cancer. We are pleased that the FDA is reviewing this sBLA and we look forward to potentially extending the monotherapy indication for Keytruda to locally advanced or metastatic patients whose tumors express PD-L1, with a tumor proportion score of 1% or more,” Roy Baynes, MD, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, said in a statement.

This is the latest in good news for Merck, as last week pembrolizumab also earned European approval, in combination with platinum-based pemetrexed, for the first-line treatment of metastatic nonsquamous NSCLC in adults whose tumors have no EGFR or ALK aberrations. The approval marked the first immunotherapy available in Europe for previously untreated patients.

In addition to KEYNOTE-042, Merck is currently undergoing 10 phase 3 trials evaluating Keytruda in lung cancer both as a combination therapy and as a monotherapy across histologies and lines of treatment in both advanced and earlier stages of disease.

The FDA has set a Prescription Drug User Fee Act date of January 11, 2019.