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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.”

Dr Funmi Olopade

Funmi Olopade, MD, FACP, professor of medicine and human genetics and founding director of the Center for Clinical Cancer Genetics and Global Health at the University of Chicago Medical Center, explains advancements in BRCA testing and how genetic testing has become standard of care.

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