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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

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  • 05 Dec 2022 9:25 AM | Katy Monaco (Administrator)

    Rigel Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved REZLIDHIA™ (olutasidenib) capsules for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. REZLIDHIA is an oral, small molecule, inhibitor of mutated IDH1 designed to bind to and inhibit mIDH1 to reduce 2-hydroxyglutarate levels and restore normal cellular differentiation of myeloid cells. Read More. 

  • 21 Nov 2022 11:37 AM | Katy Monaco (Administrator)

    FDA approved a new Monday-Wednesday-Friday dosing regimen for asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze, Jazz Pharmaceuticals). Under the new regimen, patients should receive 25 mg/m2 intramuscularly on Monday and Wednesday mornings, and 50 mg/m2 intramuscularly on Friday afternoon. It also is approved to be administered every 48 hours at a dose of 25 mg/m2 intramuscularly.  Read More.

  • 11 Nov 2022 3:03 PM | Katy Monaco (Administrator)

    The Food and Drug Administration approved brentuximab vedotin (Adcetris, Seagen, Inc.) in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide for pediatric patients 2 years of age and older with previously untreated high risk classical Hodgkin lymphoma (cHL). This is the first pediatric approval for brentuximab vedotin. Read More.

  • 11 Nov 2022 3:01 PM | Katy Monaco (Administrator)

    The Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab (Imfinzi, AstraZeneca Pharmaceuticals) and platinum-based chemotherapy for adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. Read More

  • 09 Nov 2022 1:30 PM | Katy Monaco (Administrator)

    Food and Drug Administration approved LIBTAYO® (cemiplimab-rwlc)  (Regeneron Pharmaceuticals, Inc.) in combination with platinum-based chemotherapy for adult patients with advanced non-small cell lung cancer (NSCLC) with no EGFR, ALK, or ROS1 aberrations.  Read More

    Please see additional Important Safety Information below and the full LIBTAYO Prescribing Information here or go to www.libtayohcp.com.

  • 28 Oct 2022 10:15 AM | Katy Monaco (Administrator)

    Food and Drug Administration granted accelerated approval to teclistamab-cqyv (Tecvayli, Janssen Biotech, Inc.), the first bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Read More.

  • 24 Oct 2022 10:14 AM | Katy Monaco (Administrator)

    Food and Drug Administration approved IMJUDO® (tremelimumab-actl), (AstraZeneca Pharmaceuticals) in combination with IMFINZI® (durvalumab) for adult patients with unresectable hepatocellular carcinoma (uHCC). Read More. 

    Please see Full Prescribing Information including Medication Guide for IMFINZI and IMJUDOYou may report side effects related to AstraZeneca products by clicking here.

  • 23 Sep 2022 8:32 AM | Katy Monaco (Administrator)

    The Food and Drug Administration granted accelerated approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult patients with locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options. Read More.

  • 23 Sep 2022 8:30 AM | Katy Monaco (Administrator)

    The Food and Drug Administration granted regular approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test.  Today, FDA also approved the Oncomine Dx Target (ODxT) Test (Thermo Fisher Scientific) as a companion diagnostic for selpercatinib.  Read more


  • 06 Sep 2022 8:51 AM | Katy Monaco (Administrator)

    The Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca UK Limited) in combination with gemcitabine and cisplatin for adult patients with locally advanced or metastatic biliary tract cancer (BTC). More information

    The attached document provides a summary of key results from the TOPAZ-1 trial, along with other important information about the use of IMFINZI in patients with advanced BTCs.

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