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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

  • 26 Mar 2019 10:15 AM | Anonymous

    The U.S. Food and Drug Administration granted accelerated approval to atezolizumab (TECENTRIQ, Genentech Inc.) in combination with paclitaxel protein-bound for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] of any intensity covering ≥ 1% of the tumor area), as determined by an FDA-approved test. Read full press release.

  • 26 Mar 2019 8:47 AM | Anonymous

    The U.S. Food and Drug Administration approved atezolizumab (Tecentriq; Genentech) in combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). Read full press release. 

  • 25 Feb 2019 10:54 AM | Anonymous

    The U.S. Food and Drug Administration approved pembrolizumab (Keytruda; Merck) for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection. Read full press release

  • 05 Feb 2019 1:50 PM | Anonymous

    The U.S. Food and Drug Administration approved the expanded use of ibrutinib (imbruvica; Pharmacyclics) in combination with obinutuzumab for adult patients with chronic lymphocytic leukemia or small lymphocytic leukemia (CLL/SLL). Read full press release.

  • 15 Jan 2019 2:45 PM | Anonymous

    The U.S. Food and Drug Administration approved cabozantinib (Cabometyz; Exelixis) for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. Read full press release.

  • 14 Jan 2019 3:27 PM | Anonymous

    The U.S. Food and Drug Administration approved gilteritinib (Xospata; Astellas) for treatment of adult patients who have relapsed or refractory acut myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA approved test. Read full press release.

  • 14 Jan 2019 3:24 PM | Anonymous

    The U.S. Food and Drug Administration approved atezolizumab (Tecentriq; Genentech) in combination with bevacizumab, paclitaxel, and carboplatin for the first-line treatment of patients with metastatic non-squamous, non-small cell lung cancer (NSq NSCLC) with no EGFR or ALK genomic tumor aberrations. Read full press release.

  • 14 Jan 2019 3:08 PM | Anonymous

    The U.S. Food and Drug Administration approved romiplostim (Nplate; Amgen) for pediatric patients 1 year of age and older with immune thrombocytopenia (ITP) for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Read full press release

  • 14 Jan 2019 3:02 PM | Anonymous

    The U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (Keytruda; Merck) for adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). Read full press release.

  • 14 Jan 2019 2:26 PM | Anonymous

    The U.S. Food and Drug Administration approved olaparib (Lynparza; AstraZeneca Pharmaceuticals) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Read full press release.

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