FDA Cancer Drug Approval Rate Highlighted in JNCI
A review in the Journal of the National Cancer Institute gives positive feedback on US FDA’s rate of cancer drug approval. Between July 2005 and end of 2007, the regulatory body Office of Oncology Drug Products approved more than 50 new indications in oncology as well as hematology drugs and biologics. In addition, the review reports:
- New treatments were approved for six of the seven most deadly forms of cancer in the United States (lung, colon, breast, ovarian, cervical and pancreatic)
- 35 of the approvals were existing products seeking new treatment indications
- New molecular entities represented 18, or 34 percent, of the 53 approvals
- Approvals included treatments for pediatric patients, supportive care indications aimed at improving the side effects of cancer therapies, and treatment options for rare diseases
- Three new treatments were approved for advanced kidney cancer
- Nine drugs received accelerated approval, a regulatory mechanism allowing the FDA to approve a drug with subsequent studies performed after approval to demonstrate an effect on survival or other clinically meaningful endpoints
- Twenty five percent of the indications approved were based on improvement in overall survival or improvement in both progression-free survival and overall survival
FDA Approves Rituxan to Treat Chronic Lymphocytic Leukemia
One of the latest approved cancer drug is Rituxan (rituximab), indicated for the treatment of chronic lymphocytic leukemia (CLL). CLL is a slowly progressing cancer of the blood and bone marrow primarily affecting people older than 50. It arises from a group of white blood cells known as B-cells—part of the body’s immune system. About 16,000 people in the US are diagnosed with CLL each year, resulting in 4,400 deaths. Rituxan is indicated for patients for chemotherapy-naive as well as chemotherapy-experienced patients not responding to ongoing therapy. Rituxan is administered in combination with two other chemotherapy drugs, fludarabine and cyclophosphamide.
According to Dr. Richard Pazdur, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research
“Rituxan is the third drug approved for the treatment of CLL since 2008 and underscores FDA’s commitment to expediting the development and approval of drugs for patients with serious and life-threatening diseases.”
Merck: Studies boost Gardasil for new uses
The HPV vaccine Gardasil is effective against other conditions, according to its manufacturer Merck. Gardasil was initially approved for prevention of cervical cancer in females from age 9 to 26. Last year, it was approved for the prevention of genital warts in males aged 9 to 26. New studies indicate that the vaccine is also effective in preventing cervical cancer and genital warts in older women (up to 45 years) and anal cancer in men. Merck is applying for approval for these new indications.
Wishing you all a relaxing weekend!