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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

  • 31 May 2022 7:43 AM | Katy Monaco (Administrator)

    The Food and Drug Administration approved ivosidenib (Tibsovo, Servier Pharmaceuticals LLC) in combination with azacitidine for newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Press Release. Please see full Prescription Information

  • 30 May 2022 11:24 AM | Katy Monaco (Administrator)

    Novartis announced the US Food and Drug Administration (FDA) has granted accelerated approval for Kymriah® (tisagenlecleucel) for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy. More Information.

  • 27 May 2022 8:05 AM | Katy Monaco (Administrator)
    The FDA approved Opdivo+Chemo and Opdivo+Yervoy Regimens For First-Line Treatment of Patients with Unresectable, Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC).  For more information on this approval, click here for the press release.
  • 23 May 2022 7:45 AM | Katy Monaco (Administrator)

    The Food and Drug Administration approved azacitidine (Vidaza, Celgene Corp.) for pediatric patients with newly diagnosed juvenile myelomonocytic leukemia (JMML). More Information.

  • 09 May 2022 8:03 AM | Katy Monaco (Administrator)
    FDA Approves Daiichi Sankyo's ENHERTU® (fam-trastuzumab deruxtecan-nxki) for Patients with HER2 Positive Metastatic Breast Cancer Treated with a Prior Anti-HER2-Based Regimen. More Information
  • 07 Apr 2022 11:35 AM | Katy Monaco (Administrator)

    U.S. Food and Drug Administration (FDA) granted accelerated approval to Vijoice® (alpelisib) for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy.Vijoice is the first FDA-approved treatment for PROS, a spectrum of rare conditions characterized by overgrowths and blood vessel anomalies impacting an estimated 14 people per million.2,3 In accordance with the Accelerated Approval Program, continued approval may be contingent upon verification and description of clinical benefit from confirmatory evidence. More Information

  • 04 Apr 2022 7:25 AM | Katy Monaco (Administrator)

    Food and Drug Administration approved axicabtagene ciloleucel (Yescarta, Kite Pharma, Inc.) for adult patients with large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy. It is not indicated for the treatment of patients with primary central nervous system lymphoma. More Information. Please see full Prescribing Information.

  • 28 Mar 2022 7:32 AM | Katy Monaco (Administrator)

    Food and Drug Administration approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan, Advanced Accelerator Applications USA, Inc., a Novartis company) for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy. More Information

  • 21 Mar 2022 8:28 AM | Katy Monaco (Administrator)
    OpdualagTM (nivolumab and relatlimab-rmbw), a new,  first-in-class, fixed-dose combination of nivolumab and relatlimab, administered as a single intravenous infusion, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. More Information


  • 14 Mar 2022 8:46 AM | Katy Monaco (Administrator)
    AstraZeneca and MSD’s Lynparza (olaparib) has been approved in the US for the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm) HER2-negative high-risk early breast cancer who have already been treated with chemotherapy either before or after surgery. Please see the attached document for more information regarding the use of LYNPARZA in this new indication. Press Release

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