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FDA APPROVALS

Complete List of FDA Oncology Approval Notifications

To see a complete list of FDA Oncology (Cancer) / Hematologic Malignancies Approval Notifications, visit the FDA's website.

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MSCO CORPORATE MEMBER APPROVALS

  • 16 Aug 2019 10:58 AM | Anonymous

    The U.S. Food and Drug Administration granted accelerated approval to entrectinib (Rozlytrek; Genentech) for adults and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory standard therapy. Read full press release. 

  • 01 Aug 2019 7:40 AM | Anonymous

    The U.S. Food and Drug Administration approved pembrolizumab (Keytruda; Merck) for patients with recurrent, locally advanced or metastatic, squamous cell carcinoma of the esophagus (ESCC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10), as determined by an FDA-approved test, with diesease progression after one or more prior lines of systemic therapy. Read full press release. 

  • 28 Jun 2019 11:10 AM | Anonymous

    The U.S. Food and Drug Administration approved daratumumab (DARZALEX, Janssen Biotech, Inc.) in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. Read full press release. 

  • 18 Jun 2019 12:01 PM | Anonymous

    The U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (Keytruda; Merck) for patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. Read full press release. 

  • 11 Jun 2019 9:06 AM | Anonymous

    The U.S. Food and Drug Administration approved pembrolizumab (Keytruda; Merck) for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC). Read full press release. 

  • 10 Jun 2019 2:06 PM | Anonymous

    The U.S. Food and Drug Administration granted accelerated approval to polatuzumab vedotin-piiq (Polivy; Genentech), a CD79b-directed antibody-drug conjugate indicated in combination with bendamustine and a rituximab product for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after at least two prior therapies. Read full press release.

  • 05 Jun 2019 11:51 AM | Anonymous

    The U.S. Food and Drug Administration approved the addition of overall survival data in labeling for gilteritinib (Xospata; Astellas) indicated for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. Read full press release. 

  • 28 May 2019 8:02 AM | Anonymous

    The U.S. Food and Drug Administration approved alpelisib (Piqray; Novartis) in combination with fulvestrant for postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen. Read full press release. 

  • 16 May 2019 8:48 AM | Anonymous

    The U.S. Food and Drug Administration approved Herzuma (trastuzumab-pkrb; Celltrion) as a biosimilar to Herceptin (trastuzumab; Genentech) for patients with HER2-overexpressing breast cancer. Read full press release.

  • 16 May 2019 8:24 AM | Anonymous

    The U.S. Food and Drug Administration approved ado-trastuzumab emtansine (Kadcyla; Genentech) for the adjuvant treatment of patients with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. Read full press release. 

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