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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.

FDA WEBSITE


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MSCO CORPORATE MEMBER APPROVALS

  • 29 Aug 2022 8:53 AM | Katy Monaco (Administrator)

    The Food and Drug Administration approved pemigatinib (Pemazyre, Incyte Corporation) for adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor receptor 1 (FGFR1) rearrangement. More information

  • 26 Aug 2022 7:08 AM | Katy Monaco (Administrator)

    The Food and Drug Administration approved ibrutinib (Imbruvica, Pharmacyclics LLC) for pediatric patients ≥ 1 year of age with chronic graft versus host disease (cGVHD) after failure of 1 or more lines of systemic therapy. Formulations include capsules, tablets, and oral suspension.  For more information, read the FDA Announcement or Press Release.

  • 12 Aug 2022 10:19 AM | Katy Monaco (Administrator)

    Food and Drug Administration granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptor 2 HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. This is the first drug approved for HER2-mutant NSCLC. For more information about this approval, you can find Daiichi Sankyo’s press release here and AstraZeneca’s press release here. 

    See the FDA approved indication and Important Safety Information below. Please see accompanying full Prescribing Information, including Boxed WARNINGS, and Medication Guide.

  • 12 Aug 2022 10:18 AM | Katy Monaco (Administrator)

    Food and Drug Administration granted regular approval to capmatinib (Tabrecta, Novartis Pharmaceuticals Corp.) for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation leading to mesenchymal-epithelial transition (MET) exon 14 skipping, as detected by an FDA-approved test.  Read More

  • 05 Aug 2022 5:00 PM | Katy Monaco (Administrator)

    The Food and Drug Administration approved darolutamide (Nubeqa, Bayer HealthCare Pharmaceuticals Inc.) tablets in combination with docetaxel for adult patients with metastatic hormone-sensitive prostate cancer (mHSPC). Read More.

  • 05 Aug 2022 3:00 PM | Katy Monaco (Administrator)
    The Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH‑) breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy. Read More.
  • 18 Jul 2022 7:49 AM | Katy Monaco (Administrator)

    The FDA approves crizotinib (Xalkori, Pfizer Inc.) for adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumors (IMT).  Read More

  • 27 Jun 2022 2:22 PM | Katy Monaco (Administrator)

    Bristol Myers Squibb announced that the FDA has approved Breyanzi® (lisocabtagene maraleucel) for the treatment of adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have:  • Refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or  • Refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplant (HSCT) due to comorbidities or age.  More Information

  • 27 Jun 2022 9:02 AM | Katy Monaco (Administrator)
    The Food and Drug Administration granted accelerated approval to dabrafenib (Tafinlar, Novartis) in combination with trametinib (Mekinist, Novartis) for the treatment of adult and pediatric patients ≥ 6 years of age with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. Dabrafenib in combination with trametinib is not indicated for patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition. Dabrafenib is not indicated for patients with wild-type BRAF solid tumors. More Information
  • 02 Jun 2022 9:01 AM | Katy Monaco (Administrator)

    Due to safety concerns, the U.S. Food and Drug Administration (FDA) has withdrawn its approval for the cancer medicine Ukoniq (umbralisib).  Ukoniq was approved to treat two specific types of lymphoma: marginal zone lymphoma (MZL) and follicular lymphoma (FL). More Information

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