FDA uses pilot programme to usher through speedy expanded full approval of Merck & Co.'s Keytruda in non-squamous NSCLC

The FDA announced that it used its Real Time Oncology Review for the second time in its decision to convert accelerated approval of Merck & Co.'s Keytruda (pembrolizumab) to full clearance for use, together with Eli Lilly's Alimta (pemetrexed) and platinum chemotherapy, in the first-line treatment of patients with metastatic non-squamous non-small-cell lung cancer (NSCLC) who do not have EGFR or ALK genomic tumour aberrations. 

The agency's pilot programme, which was first employed to recently expand the label of Novartis' breast cancer drug Kisqali (ribociclib) less than one month after filing, allows its review teams to begin analysing data before companies submit a formal marketing application.

Keytruda had gained accelerated approval in the first-line non-squamous NSCLC indication based on tumour response rates and progression-free survival (PFS) data from the Phase II KEYNOTE-021 study. Merck said full clearance was supported by late-stage results from the KEYNOTE-189 trial, which showed that first-line Keytruda plus Alimta and chemotherapy significantly improved overall survival and PFS in patients with advanced or metastatic non-squamous NSCLC, versus Alimta and chemotherapy alone. 

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. 

"Keytruda is rapidly becoming a foundation for the treatment of appropriate patients with metastatic NSCLC," commented Roger Perlmutter, president of Merck Research Laboratories. In 2016, the FDA cleared Keytruda as monotherapy in the first-line treatment of patients with metastatic NSCLC whose tumours have high PD-L1 expression, but no EGFR or ALK genomic tumour aberrations.

The drug was initially awarded accelerated approval in 2014 in the US for the treatment of advanced or unresectable melanoma, marking the first approval of a PD-1 inhibitor in the country. 

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