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Oncology Newsfeed

  • GSK Shares Plans to Voluntarily Withdraw Niraparib

    GlaxoSmithKline (GSK) is planning to voluntarily withdraw the indication of niraparib for treatment of adult patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency positive status.

    For more information read the GSK letter.

    Posted 9/7/2022



  • FDA Approves Pemigatinib for MLNs with FGFR1 Rearrangement

    On August 26, 2022, the U.S Food and Drug Administration (FDA) approved pemigatinib for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor receptor 1 (FGFR1) rearrangement.

    For more information, read the FDA announcement. 

    Posted 8/30/2022



  • CMS Delays Radiation Oncology Model For Further Rulemaking

    On August 29, 2022, the Centers for Medicare & Medicaid Services (CMS) published a final rule (CMS-5527-F2) that finalized delaying the Radiation Oncology Model start date until a date is determined through future rulemaking.

    For more information, visit the Radiation Oncology Model website.

    Posted 8/30/2022



  • FDA Approves Ibrutinib for Pediatric Patients with Chronic Graft-Versus-Host Disease

    On August 24, 2022, the U.S  Food and Drug Administration (FDA) approved ibrutinib for the treatment of pediatric patients one year and older with chronic graft-versus-host disease after failure of one or more lines of systemic therapy. 

    For more information, read the FDA announcement. 

    Posted 8/25/2022



  • FDA Approves Guardant360 CDx for HER2-Mutant NSCLC

    On August 12, 2022, the U.S. Food and Drug Administration (FDA) approved Guardant360® CDx liquid biopsy test as a companion diagnostic (CDx) to select patients with unresectable or metastatic HER2-mutant non-small cell lung cancer (NSCLC), whose tumors have activating human epidermal growth factor receptor 2 HER2 (ERBB2) mutations, for treatment with AstraZeneca and Daiichi Sankyo's Enhertu® (fam-trastuzumab deruxtecan-nxki).

    For more information, read Guardant Health's announcement.

    Posted 8/15/2022



  • FDA Approvees Fam-Trastuzumab Deruxtecan-nxki for HER2-Mutant NSCLC

    On August 11, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to fam-trastuzumab deruxtecan-nxki 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.

    For more information, read the FDA announcement or the AstraZeneca and Daiichi Sankyo announcement.

    Posted 8/15/2022



  • FDA Approves Capmatinib for Metastatic NSCLC

    On August 10, 2022, the U.S. Food and Drug Administration (FDA) granted regular approval to capmatinib 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.

    For more information, read the FDA announcement.

    Posted 8/15/2022



  • FDA Approves New Acalabrutinib Formulation

    On August 5, 2022, the U.S. Food and Drug Administration approved the new tablet formulation for acalabrutinib for all current indications, including chronic lymphocytic leukaemia, small lymphocytic lymphoma, and relapsed or refractory mantle cell lymphoma.

    For more information, read AstraZeneca's announcement.

    Posted 8/12/2022



  • AstraZeneca Plans to Withdraw an Olaparib Indication for Ovarian Cancer

    On August 11, 2022, AstraZeneca released a letter stating that that there is a "potential detrimental effect on the overall survival" for olaparib. Therefore, the company has announced it is planning to voluntarily withdraw the olaparib indication for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.

    For more information, read the letter sent by AstraZeneca.

    Posted 8/11/2022




  • FDA Approves Label Expansion for VENTANA MMR RxDx Panel

    On August 11, 2022, the U.S Food and Drug Administration (FDA)  approved a label expansion for the VENTANA MMR RxDx Panel, a companion diagnostic test to aid in identifying patients whose solid tumors are deficient in DNA mismatch repair, and who may be eligible for treatment with Keytruda®(pembrolizumab).

    For more information read the Roche announcement.  

    Posted on 8/11/2022