Breast Cancer

FDA grants BT designation to Novartis’ ribociclib for initial endocrine-based treatment in some pts with HR+/HER2– advanced or mBC

Novartis receives Food and Drug Administration (FDA) Breakthrough Therapy (BT) designation for ribociclib (Kisqali), an initial endocrine-based treatment of pre- or perimenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2–) advanced or metastatic breast cancer (mBC) in combination with tamoxifen or an aromatase inhibitor (AI).

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Novartis

FDA updates label of Novartis’ nilotinib to include treatment discontinuation recommendations for CML after sustained response

The Food and Drug Administration (FDA) updates the product label for nilotinib (Tasigna, Novartis) to include dosing recommendations for patients with chronic myeloid leukemia in the chronic phase (CML-CP) who have been taking nilotinib for 3 years or more, and whose leukemia has responded to treatment according to specific criteria as detected by a test […]

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Seattle Genetics

FDA accepts sBLA and grants Priority Review to Seattle Genetics’ brentuximab vedotin for frontline advanced cHL

Seattle Genetics confirms that the Food and Drug Administration (FDA) has accepted for filing a supplemental Biologics License Application (sBLA) for brentuximab vedotin (Adcetris) plus AVD (Adriamycin, vinblastine, dacarbazine) compared with a recognized standard of care chemotherapy regimen, ABVD (which includes bleomycin), for the frontline treatment of patients with advanced classical Hodgkin lymphoma (cHL).

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