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Fast Track Designations for Drugs for Castration-Resistant Prostate Cancer & Chemotherapy-Induced Neuropathy

doi: 10.1097/01.COT.0000406626.82165.0b

The investigational agent Radium-223 chloride has been granted Fast Track designation by the Food and Drug Administration for the treatment of patients with castration-resistant prostate cancer that has spread to the bone.

The drug, made by Bayer HealthCare Pharmaceuticals, is not yet approved by the FDA, the European Medicines Agency, or other health authorities.

Radium-223 chloride contains an alpha-particle emitting nuclide. In September 2009, Bayer signed an agree-ment with Algeta ASA of Oslo, Norway for the development and commercializa-tion of the agent. Under the terms of the agreement, Bayer will develop, apply for global health authority approvals, and commercialize radium-223 chloride globally, while Algeta retains an option for up to 50/50 co-promotion and profi t-sharing in the United States.

Also receiving the Fast Track designation is the investigational drug KRN5500 for the treatment of chemotherapy–induced neuropathic pain in cancer patients.

KRN5500, made by DARA Biosciences, is described by the company as a novel spicamycin-derived, non-narcotic/non-opioid, analgesic agent produced by Streptomyces alanosinicus. The drug showed positive results in a Phase II clinical trial that met its primary endpoints of reduction of pain and safety and was superior to placebo. The NCI is now partnering with the company to start a second Phase II study, which is expected to start by the end of the year.

“We see a lot of patients with chemotherapy-induced neuropathic pain, a group of people I find personally distressing to treat because they have such difficult problems, and many of them have long lives ahead of them, but have severe pain problems,” Amy P. Abernethy, MD, Director of the Duke Cancer Care Research Program, said in a news release. “No matter where they are in the course of their illness, I think that KRN5500 holds promise as a potential help.”

The drugs that have been particularly linked to chemotherapy-induced peripheral neuropathy are platinum drugs (cisplatin, carboplatin, and oxaliplatin); taxanes (paclitaxel and docetaxel); epothilones (ixabepilone); plant alkaloids (vinblastine, vincristine, vinorelbine, and etoposide); thalidomide; lenalidomide; and bortezomib.

Copyright © 2011 Wolters Kluwer Health, Inc. All rights reserved.
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