During the past week, FDA approved another indication in the $22 billion a year franchise's target markets. Here's the press release from Merck, and a bit:
. . .[T]he U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with gemcitabine and cisplatin, for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC).
The approval was based on results from the Phase 3 KEYNOTE-966 trial, in which KEYTRUDA plus chemotherapy demonstrated a statistically significant improvement in the study’s primary endpoint of overall survival (OS), reducing the risk of death by 17% (HR=0.83 [95% CI, 0.72-0.95]; one-sided p=0.0034) compared to chemotherapy alone at the trial’s pre-specified final analysis for OS. Median OS was 12.7 months (95% CI, 11.5-13.6) for KEYTRUDA plus chemotherapy versus 10.9 months (95% CI, 9.9-11.6) for chemotherapy alone. This approval marks the sixth indication for KEYTRUDA in gastrointestinal cancers. . . .
As ever, quite impressive. Who would have guessed that just twelve birthdays / trips around the Sun ago, while Merck was still foundering in the fallout of the Vytorin® / cholesterol management joint venture with by then disappearing Schering Plough. . . a market transformingly new and extremely effective cancer therapy would come out of what was then Whitehouse Station?
How things change -- Merck was struggling to reach $40 a share on the NYSE then. Now? Over $100, indeed. Grinning, to the south and east -- in the sunshine.
नमस्ते
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