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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
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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Uniting to Support Patients With Cancer Beyond Treatment
November 17th 2024Kasey Bond, MPH, of Perlmutter Cancer Center at NYU Langone Health, speaks to why it’s vital to keep patients at the center of all strategic partnerships between academic institutions and community-based oncology practices.
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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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Bridging Cancer Care Gaps and Overcoming Medical Mistrust
November 13th 2024In this clip from our interview with Oscar B. Lahoud, MD, cochair of our Institute for Value-Based Medicine® evening hosted with NYU Langone Health, he addressed medical mistrust in underrepresented communities.
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How English- and Spanish-Preferring Patients With Cancer Decide on Emergency Care
November 13th 2024Care delivery innovations to help patients with cancer avoid emergency department visits are underused. The authors interviewed English- and Spanish-preferring patients at 2 diverse health systems to understand why.
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