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FDA

The supplemental new drug application (sNDA) filing includes data from 2 pivotal randomized phase 3 global studies, ALPINE and SEQUOIA, of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). The target action date is October 22, 2022.

Pemazyre

Drugs targeting FGFR mutations, which are seen in patients with intrahepatic cholangiocarcinoma (CCA), have generated particular excitement; the authors note that prior to the approval of pemigatinib, the first targeted therapy approved by FDA, only 15% to 25% of patients with CCA were “fit enough to receive second-line chemotherapy.”

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