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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

  • 01 Nov 2021 1:59 PM | Katy Monaco (Administrator)

    Novartis announced that the US Food and Drug Administration (FDA) approved Scemblix® (asciminib) for the treatment of chronic myeloid leukemia (CML) in two distinct indications. More Information.

  • 01 Nov 2021 9:32 AM | Katy Monaco (Administrator)

    Zanubrutinib has received accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) previously treated with at least one anti-CD20-based regimen.  More Information.

  • 15 Oct 2021 10:46 AM | Katy Monaco (Administrator)

    The Food and Drug Administration approved atezolizumab (Tecentriq, Genentech, Inc.) for adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-approved test. More information.

  • 13 Oct 2021 1:25 PM | Katy Monaco (Administrator)

    The Food and Drug Administration approved pembrolizumab (Keytruda, Merck) in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1), as determined by an FDA-approved test.  More Information.

  • 12 Oct 2021 7:03 AM | Katy Monaco (Administrator)

    The Food and Drug Administration approved abemaciclib (Verzenio, Eli Lilly and Company) with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score ≥20%, as determined by an FDA approved test. This is the first CDK 4/6 inhibitor approved for adjuvant treatment of breast cancer.  More Information

  • 07 Oct 2021 5:30 PM | Katy Monaco (Administrator)
    The Food and Drug Administration granted recognition to a partial listing of the Memorial Sloan Kettering Cancer Center’s Oncology Knowledge Base (OncoKB) as the first tumor mutation database to be included in the Public Human Genetic Variant Databases.  October 7, 2021.  More Information.
  • 18 Sep 2021 7:11 AM | Katy Monaco (Administrator)

    The Food and Drug Administration approved cabozantinib (Cabometyx, Exelixis, Inc.) for adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are ineligible or refractory to radioactive iodine.  More Information

  • 16 Sep 2021 8:00 AM | Katy Monaco (Administrator)

    The US Food and Drug Administration (FDA) has approved EXKIVITY™ (mobocertinib), the first oral therapy to target epidermal growth factor receptor (EGFR) exon 20 insertion mutations in metastatic non-small cell lung cancer (NSCLC). More information.  September 15, 2021. Press Release.

  • 31 Aug 2021 3:22 PM | Katy Monaco (Administrator)
    Food and Drug Administration approved zanubrutinib (Brukinsa, BeiGene) for adult patients with Waldenström’s macroglobulinemia (WM).  Press ReleaseAugust 31, 2021.  More information.
  • 14 Aug 2021 8:00 AM | Katy Monaco (Administrator)
    Food and Drug Administration approved WELIREG™ (belzutifan) 40-mg tablets. WELIREG is indicated for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery. Press Release. August 12, 2021. Drug Information.

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