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FDA, NCI plan to streamline cancer drug development
The U.S. Food and Drug Administration (FDA) and the National Cancer Institute (NCI) have recently announced that they will share knowledge and resources to facilitate the development of new cancer drugs and speed their delivery to patients. The planned agreement will enhance existing programs and add new joint programs to the existing close cooperative relationship between NCI and FDA, both of which are part of the Department of Health and Human Services (HHS).
An NCI/FDA Oncology Task Force, which comprises senior staff from both agencies, will oversee implementation of the specific components of the agreement. Areas of collaboration should include the following:
These drugs recently received final approval from the U.S. Food and Drug Administration (FDA):
• Bortezomib injection (Velcade) by Millennium Pharmaceuticals. The FDA has approved bortezomib injection (Velcade) as a new treatment for multiple myeloma. The FDA reviewed the application for this drug in less than four months. Bortezomib injection is the first in a new class of anticancer agents known as proteasome inhibitors.
Bortezomib injection is indicated for patients whose disease has relapsed after two prior treatments and who have demonstrated resistance to their last treatment. The FDA evaluated the safety and efficacy of bortezomib injection based on a study of 202 patients who had received at least two prior therapies and demonstrated disease progression on their most recent therapy. Altogether, out of 188 patients evaluated for response, 28% showed a response to bortezomib injection. The response lasted a median time of one year. Another trial in 54 patients with relapsed multiple myeloma showed similar responses.
There are no controlled trials yet of bortezomib injection demonstrating clinical benefit, such as improvement in survival. The drug’s developer will perform additional studies after approval to address this issue.
The most commonly reported adverse events reported in clinical trials include nausea, fatigue, diarrhea, constipation, headache, decreased appetite, decreased platelets and red cells in the blood, fever, vomiting, and peripheral neuropathy.
• New indication for imatinib mesylate (Gleevec) by Novartis. The FDA has approved imatinib mesylate (Gleevec) tablets for the treatment of pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (CML) in chronic phase. Imatinib mesylate is indicated for children whose disease has recurred after stem-cell transplant or who are resistant to interferon alpha therapy.
This drug was approved under the accelerated approval program. It is the first approval of a new pediatric cancer drug treatment in more than a decade. In addition to its original approved indication for CML refractory to other treatments in adults and its expansion to use as a first-line treatment for CML, imatinib mesylate also was previously granted accelerated approval for the treatment of gastrointestinal stromal cancer. As a condition of approval, Novartis has agreed to conduct pediatric studies to gain greater insight into the drug’s use in children.
The most frequently reported adverse events reported with the use of imatinib mesylate are nausea, vomiting, diarrhea, edema (sometimes severe), and muscle cramps. A considerable reduction in white blood cells and platelets also has been reported.
The recommended dosage for pediatric populations is 260 mg/m2/day. In children, imatinib mesylate treatment can be given as a once-daily dose or, alternatively, the daily dose may be split in two—once in the morning and once in the evening.
• New indication for levofloxacin (Levaquin) by Ortho-McNeil Pharmaceutical. The FDA has approved levofloxacin (Levaquin) tablets/injection and levofloxacin in 5% dextrose injection for the treatment of chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, or Staphylococcus epidermidis. With this indication, the drug becomes the only once-daily fluoroquinolone indicated to treat chronic bacterial prostatitis. Chronic bacterial prostatitis is the tenth indication for Levaquin since the FDA first approved it in 1997.