Bristol Myers Squibb

FDA approves idecabtagene vicleucel for multiple myeloma

  • Amanda Bridges
  • March 29, 2021
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From the American Society of Clinical Oncology in cooperation with the Food and Drug Administration (FDA) and as a service to our members, ASCO will periodically distribute information about newly approved therapies for cancer patients. This helps FDA inform oncologists and professionals in oncology-related fields about recent approvals in a timely manner. Included in the…

CMS Permits Medicare Part B to impose step therapy on new starts

The Centers for Medicare and Medicaid Services (“CMS”) announced a final rule permitting Medicare Part B plans, including those administered through Medicare Advantage, to impose step therapy on new starts of Part B drugs. CMS noted that this utilization management tool will “ensure that Medicare beneficiaries pay less overall … for Part B drugs.” CMS…

FDA Approves abiraterone acetate in Combination with Prednisone for High-Risk Metastatic Castration-Sensitive Prostate Cancer

  • February 8, 2018
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On February 7, 2018, the Food and Drug Administration (FDA) approved abiraterone acetate (Zytiga, Janssen Biotech Inc.) tablets in combination with prednisone for metastatic high-risk castration-sensitive prostate cancer (CSPC). FDA initially approved abiraterone acetate with prednisone in 2011 for patients with metastatic castration-resistant prostate cancer (CRPC) who had received prior chemotherapy, and expanded the indication…

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