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FDA APPROVALS

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  • 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. October 13, 2021.  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.  October 12, 2021.  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.  September 17, 2021.  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.
  • 16 Jul 2021 7:00 AM | Katy Monaco (Administrator)
    Food and Drug Administration approved FoundationOne Liquid CDx as a companion diagnotic for TABRECTA (capmatinib.) FoundationOne Liquide CDx is now approved to identify patients with MED exon 14 (METex14) skipping metastatic non-small cell lung cancer (NSCLC) who may be appropriate for treatment with TABRECTA (capmatinib). Press Release. July 15, 2021. Drug Information.
  • 06 Jul 2021 9:00 AM | Katy Monaco (Administrator)
    Food and Drug Administration approved KEYTRUDA® (pembrolizumab) Injection 100 mg for the treatment of patients with locally advanced cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation. This follows the 2020 approval of KEYTRUDA to treat patients with recurrent or metastatic cSCC that is not curable by surgery or radiation.  Press Release.  July 6, 2021. Drug Information.  

  • 16 Nov 2020 8:04 AM | Deleted user

    The U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck & Co.) in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10) as determined by an FDA approved test. Read full press release.

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