January 31st, 2012
09:18 AM ET
Adults with metastatic basal cell cancer now have a new drug to help them battle the disease.
The Food and Drug Administration has approved Erivedge under the agency's priority review program. The program provides an expedited six-month review process for drugs that may result in major treatment advances.
Erivedge is for patients with advanced basal cell carcinoma who are not candidates for radiation or surgery, or for those whose cancer has spread. BCC is the most common form of skin cancer in the country. It grows slowly and is generally curable.
The new drug inhibits a molecular pathway called the Hedgehog pathway, which is found in most basal cell cancers.
"Our understanding of molecular pathways involved in cancer, such as the Hedgehog pathway, has enabled the development of targeted drugs for specific diseases," said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "This approach is becoming more common and will potentially allow cancer drugs to be developed more quickly. This is important for patients who will have access to more effective therapies with potentially fewer side effects."
This is the first FDA-approved treatment for metastatic BCC. It comes in pill form - a capsule that's taken once a day.
According to the drug's manufacturer, Genentech, an independent review of clinical studies found Erivedge shrank lesions in 43% of patients with locally advanced BCC and 30% in patients with metastatic BCC.
"Today's approval provides a new treatment for people with advanced basal cell carcinoma who, until now, had no approved medicines to help shrink disfiguring or potentially life-threatening lesions," said Dr. Hal Barron, chief medical officer and head, Global Product Development for Genentech.
Dr. Evan Lipson, and instructor of medical oncology at Johns Hopkins Kimmel Cancer Center has treated patients with the drug.
"Like most of the pathway therapy drugs that we are using these days, these drugs are remarkably successful compared to the chemotherapy drugs that have been available to us up until now," Lipson said. "The downside is that the effects of the drug on the tumor are not as long lasting as we would like and research is underway to develop ways to create longer lasting responses."
There are side effects , including muscle spasms, hair loss, weight loss, distorted sense of or loss of taste. Erivedge will come with a black box warning about the potential risk of death, and of severe birth defects to unborn babies. Pregnancy status must be verified before starting treatment.
According to Genentech, the drug will be available within two weeks.
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