Merck & Co. looks to speed FDA filings for Keytruda, hepatitis C combination therapy

Merck & Co. said Monday that it plans to seek FDA approvals for its PD-1 inhibitor Keytruda (pembrolizumab) and its hepatitis C therapy combining grazoprevir and elbasvir earlier this year than expected following a recent overhaul of its R&D operations. "The tempo has changed," commented, Roger Perlmutter, president of Merck Research Laboratories, adding "what we are doing is focusing our efforts more profoundly, increasing the speed at which we complete things."

The company indicated that it expects to submit an application around midyear to expand the use of Keytruda to include the treatment of patients with EGFR mutation-negative and ALK rearrangement-negative non-small-cell lung cancer (NSCLC) whose disease has progressed on or following platinum-containing chemotherapy. The compound was granted accelerated approval by the FDA in September last year for advanced or unresectable melanoma, making it the first PD-1 inhibitor cleared in the US. In addition, filings are under way in the EU and globally for advanced melanoma.

Bernstein analyst Tim Anderson recently suggested that FDA approval of Keytruda in lung cancer in the second half of 2015 would be about six to 12 months earlier than expected. Anderson estimated that such an approval would boost the product's sales this year to about $900 million, versus consensus forecasts of around $400 million. For related analysis, read ViewPoints: Could Merck & Co. deliver another stealthy US approval for Keytruda – this time in NSCLC?

On Monday, Bristol-Myers Squibb announced that a Phase III trial of its anti-PD1 immune checkpoint inhibitor Opdivo (nivolumab) versus docetaxel in previously treated patients with advanced, squamous cell NSCLC was stopped early after meeting its endpoint. The company indicated that results "for the first time indicate a survival advantage with an anti-PD1 immune checkpoint inhibitor in lung cancer."

Merck added that it also plans to file an FDA application in the first half of this year for a single tablet combining the NS3/4A protease inhibitor grazoprevir and the NS5A inhibitor elbasvir, having previously indicated that it expected to make a submission sometime during 2015. For related analysis, see Spotlight On: Can Merck & Co. still compete with Gilead in Hepatitis C? – 5 key takeaways from its new data.

The expedited submissions come after Merck launched an initiative in October 2013 to transform the drugmaker into a more competitive and innovative company and to build a platform for sustained future growth. "Over the past 15 months, we’ve seen the results of our transformation strategy, including advancing major pipeline candidates, completing multiple business development actions and securing first-in-class product approvals," remarked CEO Kenneth C. Frazier.

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