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Immuno-oncology Innovation From Amgen Set for Priority Review
The new BiTE antibody technology developed by the company can simultaneously engage 2 different targets, which can help recruit T-cells to malignant cells, and will be evaluated in ALL patients.
Amgen (NASDAQ: AMGN) today announced that the FDA has accepted for review the Biologics License Application (BLA) for the investigational bispecific T cell engager (BiTE®) antibody construct, blinatumomab. The BLA is for the treatment of adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL), a rapidly progressing cancer of the blood and bone marrow.1 As part of the acceptance, the FDA granted blinatumomab priority review with a Prescription Drug User Fee Act (PDUFA) action date of May 19, 2015.
A Marketing Authorization Application has also been submitted to the European Medicines Agency via the centralized procedure for approval to market blinatumomab for the treatment of adults with Ph- relapsed/refractory B-precursor ALL.
The submissions include data from a Phase 2 trial of adult patients with Ph- relapsed/refractory B-precursor ALL treated with blinatumomab, which met its primary endpoint.
Read Amgen's full press release: http://bit.ly/ZSxSn6
Decisions and Precision in Value-Based Cancer Care
January 7th 2025An Institute for Value-Based Medicine regional event in Houston, Texas, covered inconsistencies with the integration of precision medicine in oncology practices, the evolution of treatment for multiple myeloma, and more.
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Exploring Racial, Ethnic Disparities in Cancer Care Prior Authorization Decisions
October 24th 2024On this episode of Managed Care Cast, we're talking with the author of a study published in the October 2024 issue of The American Journal of Managed Care® that explored prior authorization decisions in cancer care by race and ethnicity for commercially insured patients.
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FDA Approves Tislelizumab-jsgr as First-Line Therapy for HER2– Gastric Cancers
January 2nd 2025Tislelizumab-jsgr (Tevimbra) was approved in combination with chemotherapy for the treatment of unresectable or metastatic HER2-negative (HER–) gastric or gastroesophageal junction adenocarcinoma (G/GEJ) in adults whose tumors express PD-L1.
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Examining Low-Value Cancer Care Trends Amidst the COVID-19 Pandemic
April 25th 2024On this episode of Managed Care Cast, we're talking with the authors of a study published in the April 2024 issue of The American Journal of Managed Care® about their findings on the rates of low-value cancer care services throughout the COVID-19 pandemic.
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