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