Regulatory Affairs

FDA grants priority review for Keytruda, chemotherapy combination in NSCLC

Published 01 May 2018

Merck said that the US Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for its anti-PD-1 therapy Keytruda based on the results of the phase 3 KEYNOTE-189 trial.

The application seeks approval for KEYTRUDA in combination with pemetrexed (ALIMTA) and platinum chemotherapy (carboplatin or cisplatin) as a first-line treatment for patients with metastatic nonsquamous non-small cell lung cancer (NSCLC).

The FDA has granted Priority Review to this sBLA and has set a Prescription Drug User Fee Act (PDUFA), or target action, date of Sept. 23, 2018.

Merck Research Laboratories president Roger Perlmutter said: “KEYTRUDA is the first immunotherapy to significantly extend survival of patients with nonsquamous non-small cell lung cancer in combination with chemotherapy as a first-line treatment, including in patients whose tumors are either PD-L1 negative or are untested.

“With this sBLA acceptance by the FDA, we are pleased that data from KEYNOTE-189 is now under review by regulatory authorities in the United States, Europe, and Japan.”

This supplemental application is based on overall survival (OS) and progression-free survival (PFS) data from the Phase 3 KEYNOTE-189 trial, which were recently presented at the American Association of Cancer Research (AACR) 2018 Annual Meeting, and published simultaneously in The New England Journal of Medicine.

KEYNOTE-189 is the confirmatory trial for KEYNOTE-021 (Cohort G), a Phase 2 study that made KEYTRUDA the only FDA-approved anti-PD-1 therapy in combination with chemotherapy (pemetrexed plus carboplatin) for the first-line treatment of patients with metastatic nonsquamous NSCLC, regardless of PD-L1 expression.

If approved by the FDA, this would mark the third indication for KEYTRUDA in metastatic NSCLC in the United States based on OS data.

Merck has an extensive clinical development program in lung cancer and is advancing multiple registration-enabling studies with KEYTRUDA in combination with other treatments and as monotherapy.

The program, which is comprised of nearly 9,000 patients across 15 Merck-sponsored clinical studies, is evaluating KEYTRUDA across multiple settings and stages of the disease.

Source: Company Press Release.