sabato, 2 maggio 2026

Notizie Newsletter

FDA Grants Ivosidenib Breakthrough Status for Relapsed/Refractory IDH1+ MDS

December 17, 2019 - The FDA has granted a breakthrough therapy designation to ivosidenib for the treatment of adult patients with relapsed/refractory myelodysplastic syndromes (MDS) who harbor IDH1 mutations. The designation is based on results from an MDS substudy of a ...
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FDA permits sale of two new reduced nicotine cigarettes through premarket tobacco product application pathway

December 17, 2019 - The U.S. Food and Drug Administration today announced it has authorized the marketing of two new tobacco products manufactured by 22nd Century Group Inc. - Moonlight and Moonlight Menthol, which are combusted, filtered cigarettes that contain a reduced ...
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FDA Panel Supports Tazemetostat for Epithelioid Sarcoma

December 18, 2019 - The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted unanimously (11-0) in favor of approving tazemetostat tablets as a treatment for patients with metastatic or locally advanced epithelioid sarcoma that is ineligible for curative surgery. ...
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FDA Approval Sought for Liso-Cel in Large B-Cell Lymphoma

December 18, 2019 - Bristol-Myers Squibb has submitted a biologics license application (BLA) to the FDA seeking approval of the anti-CD19 CAR T-cell therapy lisocabtagene maraleucel (liso-cel) for the treatment of adult patients with relapsed/refractory large B-cell lymphoma ...
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FDA approves new type of therapy to treat advanced urothelial cancer

December 18, 2019 - Today, the U.S. Food and Drug Administration granted accelerated approval to Enfortumab vedotin-ejfv, a Nectin-4-directed antibody and microtubule inhibitor conjugate, meaning the drug specifically targets cancer cells - in this case, the cell adhesion ...
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FDA Approval Sought for Tazemetostat in Follicular Lymphoma

December 19, 2019 - A new drug application (NDA) has been submitted to the FDA for tazemetostat as a treatment for patients with relapsed/refractory follicular lymphoma, with or without EZH2 activating mutations, who have received ≥2 prior lines of systemic therapy. ...
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FDA Grants Priority Review to UGN-101 for Urothelial Cancer

December 19, 2019 - The FDA has granted a priority review designation to a new drug application (NDA) for UGN-101 (mitomycin gel) for the treatment of patients with low-grade, upper tract urothelial cancer (UTUC). The designation is based on results from the pivotal phase ...
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FDA Approves Trastuzumab Deruxtecan for HER2+ Breast Cancer

December 20, 2019 - The FDA has granted an accelerated approval to fam-trastuzumab deruxtecan-nxki (DS-8201) for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received ≥2 prior anti–HER2-based regimens in ...
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FDA Approval Sought for Tucatinib in HER2+ Breast Cancer

December 23, 2019 - Seattle Genetics, Inc., has submitted a new drug application (NDA) to the FDA for tucatinib for use in combination with trastuzumab and capecitabine for the treatment of patients with unresectable locally advanced or metastatic HER2-positive breast cancer, ...
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FDA Grants SP-2577 Fast Track Status for Ewing Sarcoma

December 23, 2019 - The FDA has granted fast track designation to the potent reversible LSD1 inhibitor SP-2577 (seclidemstat) for the treatment of relapsed/refractory patients with Ewing sarcoma. Currently, the agent is being evaluated in an ongoing, open-label, nonrandomized ...
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