FDA grants priority review to Keytruda for PD-L1-positive NSCLC

The FDA granted priority review designation to a supplemental biologics license application for pembrolizumab for the treatment of non-small cell lung cancer with PD-L1 expression of at least 1%, according to the manufacturer.

Pembrolizumab (Keytruda, Merck) is an anti-PD-1 therapy approved for the treatment of several cancer types, including as first-line treatment for patients with metastatic NSCLC with high PD-L1 expression, and for patients with metastatic NSCLC following disease progression on chemotherapy.

The FDA based the priority review on results from the phase 3 KEYNOTE-042 trial.

As HemOnc Today previously reported, researchers presented the results of this trial at ASCO Annual Meeting.

The analysis included 1,274 patients with NSCLC with a tumor proportion score of at least 1% — indicating PD-L1 expression —and no EGFR or ALK genomic tumor aberrations.

Researchers randomly assigned patients to first-line monotherapy pembrolizumab or carboplatin plus paclitaxel or carboplatin plus pemetrexed.

Patients treated with pembrolizumab lived a median of 4 to 8 months longer across PD-L1 expression groups than patients who received chemotherapy.

“Keytruda is already a foundation for the treatment of metastatic non-small cell lung cancer,” Roy Baynes, MD, PhD, senior vice president and head of global clinical development and chief medical officer at Merck Research Laboratories, said in a company-issued press release. “We are pleased that the FDA is reviewing this supplemental biologics license application, 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.”

The FDA set an action date of Jan. 11.

September 12, 2018


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