Keytruda gets accelerated OK in HER2-positive gastric cancer; TwinStrand gets $50M to hunt for 'needles in a haystack'
King Keytruda keeps racking up approvals, earning a new accelerated OK from the FDA on Wednesday.
Regulators handed down the approval for HER2-positive gastric cancer in the first-line setting, in combination with trastuzumab, fluoropyrimidine- and platinum-based chemo. It’s yet another thumbs-up for one of the best-selling drugs in the world.
Wednesday’s OK came on the basis of a 264-patient study with individuals who had not previously received treatment for their disease. Patients were randomized 1-to-1 to receive Keytruda or placebo every three weeks in addition to the chemotherapy regimen.
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