Recent FDA action (through December 2008) related to denileukin, ferumoxytol, cetuximab, HQK-1001, ALD-101, NTX-010, and RTA 402
Complete responses
• Denileukin diftitox (Ontak, Eisai) for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells did not test positive for the CD25 component of the interleukin-2 receptor
•Controlled-release hydrocodone plus acetaminophen (Abbott) for the relief of pain over 12 hours
Priority review
•Cetuximab (Erbitux, ImClone/Bristol-Myers Squibb) for use in combination with platinum-based chemotherapy for the first-line treatment of recurrent or metastatic squamous cell carcinoma of the head and neck
Orphan drug designations
•HQK-1001 (HemaQuest) for the treatment of sickle cell anemia and beta thalassemia
•ALD-101 (Aldagen) to decrease time to platelet and neutrophil engraftment in patients with inherited metabolic disorders undergoing umbilical cord blood transplantation
•NTX-010 (Neotropix) for the treatment of neuroendocrine tumors
•RTA 402 (Reata) for the treatment of pancreatic cancer
Medicare’s Drug Price Negotiations Could Impact Physician Reimbursement
September 19th 2024When CMS begins negotiations for physician-administered drugs under the Inflation Reduction Act, providers, including those whose services are covered by commercial insurance, could see lowered reimbursement.
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