Basal cell carcinoma is a form of skin cancer
caused by regular sun exposure, or other ultraviolet radiation, which
starts in the top layer of the skin (epidermis), is usually painless and
grows slowly.
The U.S. Food and Drug Administration just approved a new drug named Erivedge (vismodegib) for the treatment of adult patients with basal cell carcinoma, the most common type of skin cancer. The drug is designed for use in patients with locally advanced basal cell cancer, whose cancer has spread to other locations in the body, and who are unsuitable candidates for surgery or radiation.
The FDA has granted approval to Erivedge, ahead of the March 8, 2012 prescription user fee goal date, following a review under the agency's priority review program that designates drugs that offer major advances in treatment or provide a treatment where no adequate therapy exists.
Erivedge is administered once daily in the form of a pill and operates by blocking the Hedgehog pathway, a pathway that is active in most basal cell cancers and only a few normal tissues, such as hair follicles.
Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research said:
Erivedge's safety and efficacy was assessed in a single, multi-center clinical study that involved 96 patients with locally advanced or metastatic basal cell carcinoma. The primary endpoint was determined as objective response rate (ORR), or the percentage of patients in whom the cancerous lesions disappeared completely or achieved a partial shrinkage following treatment. Overall, Erivedge achieved a 30% partial response in patients with metastatic disease, and a 43% response rate of complete or partial response in those with locally advanced disease.
The most common side effects that patients on Erivedge experienced included: hair and weight loss, muscle spasms, fatigue, nausea, diarrhea, decreased appetite, distorted sense of taste, vomiting, constipation, and loss of taste in the tongue.
Erivedge, marketed by South San Francisco based-Genentech, a member of the Roche Group, contains a BOXED WARNING that warns patients and health care professionals of the potential mortality risk or severe birth effects to unborn babies. Prior to starting Erivedge therapy, female patients must verify their pregnancy status, and male as well as female patients must be warned about these risks and the need for birth control.
The U.S. Food and Drug Administration just approved a new drug named Erivedge (vismodegib) for the treatment of adult patients with basal cell carcinoma, the most common type of skin cancer. The drug is designed for use in patients with locally advanced basal cell cancer, whose cancer has spread to other locations in the body, and who are unsuitable candidates for surgery or radiation.
The FDA has granted approval to Erivedge, ahead of the March 8, 2012 prescription user fee goal date, following a review under the agency's priority review program that designates drugs that offer major advances in treatment or provide a treatment where no adequate therapy exists.
Erivedge is administered once daily in the form of a pill and operates by blocking the Hedgehog pathway, a pathway that is active in most basal cell cancers and only a few normal tissues, such as hair follicles.
Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research said:
"Our understanding of molecular pathways involved in cancer, such as the Hedgehog pathway, has enabled the development of targeted drugs for specific diseases. 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."
Erivedge's safety and efficacy was assessed in a single, multi-center clinical study that involved 96 patients with locally advanced or metastatic basal cell carcinoma. The primary endpoint was determined as objective response rate (ORR), or the percentage of patients in whom the cancerous lesions disappeared completely or achieved a partial shrinkage following treatment. Overall, Erivedge achieved a 30% partial response in patients with metastatic disease, and a 43% response rate of complete or partial response in those with locally advanced disease.
The most common side effects that patients on Erivedge experienced included: hair and weight loss, muscle spasms, fatigue, nausea, diarrhea, decreased appetite, distorted sense of taste, vomiting, constipation, and loss of taste in the tongue.
Erivedge, marketed by South San Francisco based-Genentech, a member of the Roche Group, contains a BOXED WARNING that warns patients and health care professionals of the potential mortality risk or severe birth effects to unborn babies. Prior to starting Erivedge therapy, female patients must verify their pregnancy status, and male as well as female patients must be warned about these risks and the need for birth control.
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