"The voice for cancer physicians and their patients in Massachusetts."

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.

FDA WEBSITE


Upcoming events

MSCO CORPORATE MEMBER APPROVALS

  • 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 | Anonymous

    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.

  • 10 Nov 2020 8:54 AM | Anonymous

    The U.S. Food and Drug Administration approved the liquid biopsy next-generation sequencing-based FoundationOne Liquid CDx test (Foundation Medicine, Inc.) as a companion diagnostic device for multiple additional biomarkers detected in cell free-DNA isolated from plasma specimens. Read full press release.

  • 26 Oct 2020 9:48 AM | Anonymous

    The U.S. Food and Drug Administration approved the next-generation sequencing (NGS)-based FoundationOne CDx test (Foundation Medicine, Inc.) as a companion diagnostic to identify fusions in neurotrophic receptor tyrosine kinase (NTRK) genes, NTRK1, NTRK2, and NTRK3, in DNA isolated from tumor tissue specimens from patients with solid tumors eligible for treatment with larotrectinib (VITRAKVI, Bayer Healthcare Pharmaceuticals, Inc.). Read full press release.

  • 22 Oct 2020 10:12 AM | Anonymous

    The U.S. Food and Drug Administration granted regular approval to venetoclax (VENCLEXTA ®, AbbVie Inc. and Genentech Inc.) in combination with azacitidine, decitabine, or low-dose cytarabine (LDAC) for newly-diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities precluding intensive induction chemotherapy. Read full press release.

  • 08 Sep 2020 8:12 AM | Anonymous

    The U.S. Food and Drug Administration approved azacitidine tablets (ONUREG®, Celgene Corporation) for continued treatment of patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy. Read full press release.

  • 05 Aug 2020 9:55 AM | Anonymous

    The U.S. Food and Drug Administration granted accelerated approval to tafasitamab-cxix (MONJUVI, MorphoSys US Inc.), a CD19-directed cytolytic antibody, indicated in combination with lenalidomide for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant. Read full press release.

  • 03 Aug 2020 7:18 AM | Anonymous

    The U.S. Food and Drug Administration approved atezolizumab (Tecentriq, Genentech, Inc.) in combination with cobimetinib and vemurafenib for patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. Read full press release.

  • 27 Jul 2020 9:47 AM | Anonymous

    The U.S. Food and Drug Administration approved pembrolizumab (KEYTRUDA, Merck & Co.) for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. Read full press release.

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