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Priority Review For Genentech's Avastin
Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) and granted Priority Review for Avastin® (bevacizumab) plus chemotherapy for the treatment of women with recurrent platinum-resistant ovarian cancer.
“The majority of women with ovarian cancer will become resistant to platinum therapy and a quarter of women will have platinum-resistant disease at the time of a first recurrence. New treatment options are needed,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We look forward to working with the FDA to bring this potential option to women with this difficult-to-treat cancer as soon as possible.”
The designation of Priority Review status is granted to medicines that the FDA believes have the potential to provide “significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.” The sBLA for Avastin plus chemotherapy for recurrent platinum-resistant ovarian cancer is based on data from the Phase III AURELIA trial with an FDA action date of November 19, 2014.
Source: Genentech
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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Texas Oncology to Roll Out Canopy for ePROs After Head-to-Head Pilot
March 18th 2025Debra Patt, MD, PhD, MBA, executive vice president of Public Policy and Strategy for Texas Oncology, said the practice received positive feedback from nurses and patients during a pilot that concluded in February.
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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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