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Amgen's T-Vec to Receive FDA Decision Today
The vaccine, approved in Europe last week, is now awaiting approval in the United States.
Imlygic, or talimogene laherparepvec, a genetically modified herpes simplex type 1 virus developed by Amgen to be injected directly into tumors, where it replicates and forces tumor cell rupture, is waiting for FDA's decision. The NDA for this virus-based treatment has been submitted for melanoma.
An advisory panel for the FDA reviewed data from the phase 3 OPTiM trial and voted 22-1 in favor of approval back in April 2015. Now the FDA has to consider this panel's advice before it's decision later today.
Meanwhile, the European Medical Agency approved T-Vec for use in patients with unresectable melanoma that has not metastatized just last week.
Read more here.
Sarcoma Care: Biomarker Advancements Shape the Future
October 24th 2024At the regional Institute for Value-Based Medicine® event in Boston, Vinayak Venkataraman, MD, medical oncologist at Dana-Farber Cancer Institute and Harvard Medical School, was a panelist for the discussion, “Recent Advancements in Identifying Predictive Biomarkers for Sarcomas."
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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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Prediagnosis Diet Improves Survival in Black Women With Deadly Ovarian Cancer
October 24th 2024Moderate prediagnosis adherence to dietary guidelines was associated with improved survival rates among Black women with high-grade serous ovarian cancer, the most common and lethal type of ovarian cancer.
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Insurance Insights: Dr Jason Shafrin Estimates DMD Insurance Value
July 18th 2024On this episode of Managed Care Cast, we're talking with the author of a study published in the July 2024 issue of The American Journal of Managed Care® that estimates the insurance value of novel Duchenne muscular dystrophy (DMD) treatment.
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Rozanolixizumab Effective in Patients with MuSK MG, Analysis Shows
October 23rd 2024A new subgroup analysis of patients with muscle-specific tyrosine kinase (MuSK) autoantibody-positive (Ab+) myasthenia gravis (MG) shows rozanolixizumab (Rystiggo) contributes to meaningful symptom improvement.
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