FDA Approves Expanded Non-Small Cell Lung Cancer Indication for Keytruda

Officials with the FDA have expanded the indication of pembrolizumab (Keytruda, Merck) for patients with metastatic, non-squamous non-small cell lung cancer (NSqNSCLC), according to a press release.

With the expanded label, the treatment is indicated for use in combination with pemetrexed and platinum as first-line treatment of patients with metastatic NSqNSCLC, with no EGFR or ALK genomic tumor aberrations. Pembrolizumab was previously granted accelerated approval for this indication in May 2017.

The expanded label is based on results from the KEYNOTE-189 clinical trial, which evaluated overall response rate and progression-free survival (PFS) for patients treated with pembrolizumab in combination with chemotherapy compared with chemotherapy alone.

In the phase 3 trial, 616 patients were enrolled to receive first-line treatment for metastatic NSqNSCLC. Patients were treated with pembrolizumab (or placebo) in combination with pemetrexed and the investigator’s choice of either cisplatin or carboplatin every 3 weeks for 4 cycles, followed by pembrolizumab (or placebo) and pemetrexed. Patients continued treatment until disease progression, unacceptable toxicity, or a maximum of 24 months.

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