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FDA Approves Calquence for Mantle Cell Lymphoma
October 31st 2017Calquence (acalabrutinib) was granted an accelerated approval by the FDA to treat adult patients with mantle cell lymphoma (MCL) following at least one prior therapy. The approval was based on objective response rates (ORR) in a single-arm trial.
Approval Sought for Avastin in the Frontline Ovarian Cancer Setting
October 30th 2017If approved, the new indication would make frontline Avastin available in combination with carboplatin and paclitaxel, followed by Avastin alone, for women with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. The FDA is expected to render a decision on the sBLA by June 25, 2018.