Late-Stage Data Advantage Or Just Late To The Game: Bristol’s Opdivo Approval Sets Off PD-1 Competition
Nivolumab approval for melanoma pits more mature data set against first-to-market advantage as company sets to compete against the first PD-1 immunotherapy to market, Merck’s Keytruda.
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Patent brawl between Merck and Gilead involving Sovaldi and Harvoni was one of the marquee litigation events of 2016; a compilation of disputes between brand-name companies over the past six years shows how consequential they can be.
FDA’s approval of Merck’s anti-PD-1 drug pembrolizumab in melanoma marks a major milestone for oncology and industry’s immune checkpoint efforts. But with an overall response rate in labeling of 24%, there’s still room for improvement with combinations and use in earlier lines of therapy.
Priced at $12,500/month, Keytruda will be ready to ship within one week of FDA approval for relapsed melanoma after failure of Yervoy and a BRAF inhibitor. Approval could spur interest in off-label use of PD-1 inhibitor as a first-line treatment.