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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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  • January 20, 2023 2:49 PM | Katy Monaco (Administrator)

    FDA announce a new approval of TUKYSA® (tucatinib, Seagen Inc.) tablets, for oral use in combination with trastuzumab for the treatment of adult patients with RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. Access the Full Prescribing Information for TUKYSA. Read More.

  • January 20, 2023 2:46 PM | Katy Monaco (Administrator)

    FDA) approved zanubrutinib (Brukinsa, BeiGene USA, Inc.) for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Read More

    View full prescribing information for Brukinsa.

  • January 02, 2023 12:15 PM | Katy Monaco (Administrator)

    FDA approval of LUNSUMIO™ (mosunetuzumab-axgb) the first-in-class follicular lymphoma (FL) T-cell engaging bispecific antibody. LUNSUMIO, as a single agent, is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Read More. 

    Please see the LUNSUMIO full Prescribing Information for additional Important Safety Information, including BOXED Warning.

  • December 16, 2022 9:10 AM | Katy Monaco (Administrator)

    The FDA approved updated labeling for capecitabine tablets (Xeloda, Genentech, Inc.) under Project Renewal, an Oncology Center of Excellence (OCE) initiative aimed at updating labeling information for certain older oncology drugs to ensure information is clinically meaningful and scientifically up to date. This is the first drug to receive a labeling update under this pilot program. Read More.

    Project Renewal is a collaborative program that leverages external oncology experts and early-career scientists to review existing published literature and gain first-hand experience in the selection, curation, and evaluation of evidence for independent FDA review. Project Renewal is intended to keep older, commonly prescribed oncology drugs’ labeling up to date, while providing transparency on FDA’s deliberative evaluation process and evidentiary standards, and improving awareness of drug labeling as an information resource for healthcare providers.

  • December 13, 2022 9:30 AM | Katy Monaco (Administrator)

    U.S. Food and Drug Administration (FDA) has granted accelerated approval for KRAZATI™ (adagrasib), a targeted treatment option for adult patients with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. Read More

  • December 12, 2022 8:24 AM | Katy Monaco (Administrator)

    Food and Drug Administration (FDA) approved atezolizumab (Tecentriq, Genentech, Inc.) for adult and pediatric patients 2 years of age and older with unresectable or metastatic alveolar soft part sarcoma (ASPS). Read more.

  • December 05, 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. 

  • November 21, 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.

  • November 11, 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.

  • November 11, 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

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