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Oncology Newsfeed

  • FDA Approves Melphalan as a Liver-directed Treatment for Uveal Melanoma

    On August 14, the US Food and Drug Administration (FDA) approved HEPZATO KIT (melphalan for Injection/Hepatic Delivery System) containing melphalan (HEPZATO, Delcath Systems, Inc.) as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.

    For more information read the FDA announcement.

    Posted 8/16/2023



  • FDA Approves FoundationOne®CDx as a Companion Diagnostic for Niraparib and Abiraterone acetate

    On August 14, the US Food and Drug Administration (FDA) approved FoundationOne®CDx to be used as a companion diagnostic for Janssen Biotech, Inc. AKEEGA™ (niraparib and abiraterone acetate Dual Action Tablet), which was approved by the FDA for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC).

    For more information read the Foundation Medicine Inc. announcement.

    Posted 8/15/2023



  • FDA Grants Accelerated Approval to Elranatamab-bcmm for Multiple Myeloma

    On August 14, the US Food and Drug Administration (FDA) granted accelerated approval to elranatamab-bcmm, a bispecific B-cell maturation antigen directed CD3 T-cell engager, for adults 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.

    For more information read the FDA announcement and Pfizer announcement.  

    Posted 8/15/2023



  • FDA Approves Niraparib and Abiraterone acetate + Prednisone for BRCA-mutated mCRPC

    On August 11, the US Food and Drug Administration (FDA) approved the fixed dose combination of niraparib and abiraterone acetate with prednisone, for adult patients with deleterious or suspected deleterious BRCA-mutated castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved test.

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

    Posted 8/15/2023



  • FDA Grants Accelerated Approval to Talquetamab-tgvs for Relapsed or Refractory Multiple Myeloma

    On August 9, the US Food and Drug Administration (FDA) granted accelerated approval to talquetamab-tgvs for adults 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.

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

    Posted 8/15/2023



  • FDA Approves Pralsetinib for NSCLC with RET Gene Fusions

    On August 9, the US Food and Drug Administration (FDA) approved pralsetinib for adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.

    For more information read the FDA announcement.

    Posted 8/10/2023



  • FDA Approves Trifluridine + Tipiracil with Bevacizumab for Previously Treated mCRC

    On August 2, the US Food and Drug Administration (FDA) approved trifluridine and tipiracil with bevacizumab, for metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. 

    For more information read the FDA announcement. 

    Posted 8/2/2023



  • FDA Approves Dostarlimab-gxly + Chemotherapy for Endometrial Cancer

    On July 31, the US Food and Drug Administration (FDA) approved dostarlimab-gxly with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for primary advanced or recurrent endometrial cancer that is mismatch repair deficient, as determined by an FDA-approved test, or microsatellite instability-high.

    For more information read the FDA announcement and the GlaxoSmithKline announcement

    Posted 8/2/2023



  • FDA Approves Quizartinib for Newly Diagnosed AML

    On July 20, the US Food and Drug Administration (FDA) approved quizartinib in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication-positive, as detected by an FDA-approved test.

    For information read the FDA announcement and the Daiichi Sankyo, Inc. announcement. 

    Posted 7/21/2023



  • FDA Approves Olaparib with Abiraterone and Prednisone (or Prednisolone) for BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer

    On May 31, 2023, the Food and Drug Administration approved olaparib (Lynparza, AstraZeneca Pharmaceuticals LP) with abiraterone and prednisone (or prednisolone) for adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved companion diagnostic test.

    For more information read the FDA announcement.

    Posted 6/22/2023