FDA Pipeline preview, December 2008 (denileukin, ferumoxytol, cetuximab, HQK-1001, ALD-101, NTX-010, RTA 402)
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
FDA Clears Phase 2 Trial of Cannabis in PTSD
November 20th 2024After a three-year negotiation, the FDA has dropped its objection to allowing patients to self-titrate dosing of smoked cannabis. But regulators want to see additional information about the device that will be used for inhalation.
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