The U.S. Food and Drug Administration will review the immuno-oncology drug Keytruda as a first-line therapy for non-small cell lung cancer (NSCLC), Merck announced Wednesday.
Keytruda won a breakthrough therapy designation and priority-review status based on data from the Phase 3 Keynote-024 trial, released in June, which showed that the PD-1 checkpoint inhibitor had significant progression-free survival and overall survival when compared with chemotherapy.
Keytruda was ok-ed as a second-line therapy for NSCLC in October. The FDA will review the drug as a first-line therapy with a target action date of December 24.
“Chemotherapy has been the foundation of first-line treatment for non-small cell lung cancer for decades, so the significant improvement in survival in patients with high PD-L1 expression seen with Keytruda compared to chemotherapy is welcome news,” said Merck R&D chief Roger Perlmutter in a statement.
In contrast, a clinical trial of Bristol-Myers’s Opdivo, also a PD-1 checkpoint inhibitor, did not show an advantage over chemotherapy in patients with NSCLC. In fact, these results suggest that oncologists will more often choose Keytruda as a treatment option, noted Reuters. Both drugs were approved by U.S. regulators last year for previously treated patients with NSCLC.
Filed Under: Drug Discovery