FDA converts Merck lung cancer drug from accelerated approval to full

Aug. 21, 2018

The U.S. Food and Drug Administration has approved Merck's Keytruda (pembrolizumab) in combination with pemetrexed and platinum as first-line treatment of patients with a certain lung cancer. This is the second FDA approval using the Real Time Oncology Review pilot program that enabled the FDA review team to begin analyzing data before the application submission.

This approval is meant for patients with metastatic, non-squamous non-small cell with no EGFR or ALK genomic tumor aberrations.

Keytruda had been granted accelerated approval for this indication in May 2017 based on improvements in overall response rate and progression-free survival for patients randomized to pembrolizumab administered with pemetrexed and carboplatin as compared with pemetrexed and carboplatin alone in the KEYNOTE-021 study.

The primary efficacy outcome measures were overall survival and progression-free survival, as assessed by a blinded independent committee review. The trial demonstrated a statistically significant improvement in OS for patients randomized to pembrolizumab and chemotherapy in a pre-specified interim analysis.

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