|Articles|August 4, 2017
FDA Drug Approvals Highlights SPT Week in Review
Author(s)Specialty Pharmacy Times Staff
Top news of the week from Specialty Pharmacy Times.
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5. FDA Approves Revisions to Epclusa Label to Include Co-Infection Clinical Trial Data
The label has been updated to include data from adults co-infected with hepatitis C virus and HIV-1.
4. FDA Grants Durvalumab Breakthrough Therapy Designation for Locally-Advanced Lung Cancer
Durvalumab is indicated to treat patients with locally-advanced, unresectable non-small cell lung cancer.
3. FDA Approves First Treatment for High-Risk Acute Myeloid Leukemia
Vyxeos is indicated to treat newly diagnosed therapy-related AML or AML with myelodysplasia-related changes.
2. FDA Approves Opdivo for Additional Indication in Colon Cancer
Nivolumab approved for form of metastatic colorectal cancer that typically does not respond to chemotherapy.
1. FDA Approves Mavyret to Treat All Major Hepatitis C Genotypes
Combination therapy cuts standard HCV treatment regimen from 12 weeks to 8 weeks.
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