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Oncology Newsfeed

  • FDA Approves Avapritinib for Indolent Systemic Mastocytosis

    On May 22, the U.S. Food and Drug Administration (FDA) approved avapritinib for the treatment of adults with indolent systemic mastocytosis.

    For more information, read the Blueprint Medicines announcement.

    Posted 5/24/2023



  • FDA Approves Epcoritamab-bysp for DLBCL

    On May 19, the U.S. Food and Drug Administration (FDA) granted accelerated approval to epcoritamab-bysp  for the treatment of adult patients with for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from indolent lymphoma and high-grade B-cell lymphoma after two or more lines of systemic therapy.

    For more information read the FDA announcement and Genmab announcement.

    Posted 5/22/2023



  • FDA Approves FoundationOne Liquid CDx as Companion Diagnostic for Mobocertinib

    On May 4, the U.S. Food and Drug Administration (FDA) approved the FoundationOne®Liquid CDx to be used as a companion diagnostic for mobocertinib, which is currently FDA-approved for adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, as detected by an FDA-approved test, and whose disease has progressed on or after platinum-based chemotherapy.

    For more information, read the Foundation Medicine announcement. 

    Posted 5/4/2023



  • FDA Approves Polatuzumab Vedotin-piiq for Previously Untreated Diffuse Large B-cell Lymphoma

    On April 19, the U.S Food and Drug Administration (FDA) approved polatuzumab vedotin-piiq with a rituximab product, cyclophosphamide, doxorubicin, and prednisone for adult patients who have previously untreated diffuse large B-cell lymphoma, not otherwise specified, or high-grade B-cell lymphoma and who have an International Prognostic Index score of 2 or greater.

    For more information, read the FDA announcement and Genentech announcement

    Posted 4/21/2023



  • FDA Approves Omidubicel for Patients with Hematologic Malignancies

    On April 17, the U.S Food and Drug Administration (FDA) approved omidubicel-onlv for use in adult and pediatric patients (12 years of age and older) with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection.

    For more information read the FDA announcement.

    Posted 4/19/2023



  • FDA Approves Enfortumab Vedotin-ejfv + Pembrolizumab for Locally Advanced or Metastatic Urothelial Carcinoma

    On April 3, U.S the Food and Drug Administration (FDA) granted accelerated approval to enfortumab vedotin-ejfv with pembrolizumab for patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy.

    For more information read the FDA announcement, the Merck announcement and the Seagen announcement. 

    Posted 4/3/2023



  • FDA Approves Expanded Indication for Illuccix® to Include Patient Selection for PSMA-Directed Radioligand Therapy

    On March 16, 2023, The U.S Food and Drug Administration approved a supplementary New Drug Application for Illuccix® (kit for the preparation of gallium Ga 68 gozetotide injection) to enable its use for the selection of patients with metastatic prostate cancer, for whom lutetium-177 (177Lu) PSMA-directed therapy is indicated. 

    For more information read the Telix Pharmaceuticals announcement.

    Posted 3/29/2023



  • Immunogen Announces C-code for Mirvetuximab Soravtansine-gynx

    Elahare announced the new Healthcare Common Procedure Coding System (HCPCS) C-code for ElahereTM (mirvetuximab soravtansine-gynx), issued by the Centers for Medicare & Medicaid Services (CMS). The code C9146 is effective April 1, 2023 for mirvetuximab soravtansine-gynx injection of 1mg and may be used on claims billed under the hospital Outpatient Prospective Payment System.

    For more information visit the Elahare website. 

    Posted 3/23/2023



  • FDA Grants Accelerated Approval to Retifanlimab-dlwr for MCC

    On March 22, 2023, the U.S Food and Drug Administration granted accelerated approval to retifanlimab-dlwr for adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).

    For more information read the FDA announcement and the Incyte announcement. 

    Posted 3/22/2023



  • FDA Approves Dabrafenib + trametinib for Pediatric Patients with LGG

    On March 16, 2023, the U.S Food and Drug Administration (FDA) approved dabrafenib with trametinib for pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.

    For more information read the FDA announcement and the Novartis announcement.

    Posted 3/20/2023