AstraZeneca, Merck win red carpet treatment at the FDA as a 3-time loser seeks speedy OK for rare tumors
AstraZeneca’s R&D group doesn’t take failure lying down.
Hit with pivotal setbacks for their MEK 1/2 inhibitor selumetinib in several cancer studies, they regrouped and included it in their $8.4 billion alliance with Merck as the therapy was steered into a Phase II for rare cases of neurofibromatosis type 1, or NF1.
That data gave the pharma giant a breakthrough drug designation in the spring, and now they are on track for a Q2 2020 PDUFA after the FDA added a priority review to the gift package today.
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