FDA accepts Merck & Co.'s Keytruda filing for first-line treatment of NSCLC, grants priority review

Merck & Co. announced Wednesday that the FDA accepted for priority review a filing seeking expanded approval of Keytruda (pembrolizumab) to include the first-line treatment of patients with advanced non-small-cell lung cancer (NSCLC) whose tumours express PD-L1. The company noted that the application has a target action date of December 24, adding that the agency granted the anti-PD-1 therapy breakthrough therapy designation for this indication.

According to Merck, the submission is supported by efficacy and safety data from the Keynote-024 study, which involved patients with previously untreated advanced NSCLC whose tumours expressed high levels of PD-L1. Results, which were reported in June, demonstrated that Keytruda was associated with significant improvements in overall survival and progression-free survival versus standard chemotherapy.

Merck Research Laboratories president Roger Perlmutter stated "chemotherapy has been the foundation of first-line treatment for [NSCLC] for decades, so the significant improvement in survival in patients with high PD-L1 expression seen with Keytruda compared to chemotherapy is welcome news." In December last year, Merck announced Phase II/III study data illustrating that Keytruda improved survival compared to chemotherapy in treatment-experienced patients with advanced NSCLC.

Keytruda was initially awarded accelerated approval by the FDA in 2014 for the treatment of advanced or metastatic melanoma. The therapy's indication was later expanded to include PD-L1-positive NSCLC in patients who disease worsened after previous treatment.

For related analysis, see ViewPoints: Could festive cheer crown 2016 as the year of Keytruda? See also KOL Views: Keytruda may be a bigger beneficiary from Opdivo's stumble than people realise, according to leading oncologist.

FirstWord reports in this therapy area - KOL Insight NSCLC: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more.

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