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FDA Approves Pemigatinib for Advanced Cholangiocarcinoma

The FDA approved pemigatinib (Pemazyre) for the treatment of patients with previously treated, advanced cholangiocarcinoma, a rare form of cancer in the bile ducts. 

The approval – the first for this patient population, that is traditionally treated with a chemotherapy combination – is for patients with locally advanced or metastatic cholangiocarcinoma who have tumors that have a fusion or other rearrangement of FGRF2.

“This approval demonstrates that while we continue to focus our efforts on addressing the COVID-19 pandemic, the FDA remains committed to the important work of reviewing treatments for patients with cancer and other serious conditions,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, in a statement. 

The approval was…

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