Erivedge for basal cell carcinoma was approved by FDA

On January 30, Erivedge (vismodegib) was approved by the U.S. Food and Drug Administration to treat adult patients with basal cell carcinoma, the most frequent type of skin cancer.

Genentech (division of Roche) developed the drug in collaboration with Curis. Erivedge will available in pharmacies within one or two weeks. The capsules have to be taken once a day and its safety in children it is unknown.

Patients with locally advanced basal cell cancer who are not candidates for surgery or radiation and patients with metastasis (cancer spread to other parts of the body) may benefit from this medicine.

Erivedge is the first FDA-approved drug for metastatic basal cell carcinoma.

This drug was approved earlier under the FDA’s priority review program for drugs that may offer major advances in treatment.

Erivedge (Vismodegib) inhibits the Hedgehog pathway in the cancer cells.

This pathway is active in most basal cell cancers and only in a few normal tissues (hair follicles).

“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,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

A clinical study that enrolled 96 patients with locally advanced or metastatic basal cell carcinoma tested the safety and effectiveness of Erivedge.

Researchers recorded the percentage of patients who experienced complete or partial shrinkage or disappearance of the cancerous lesions. In 30% of the patients with metastatic disease a partial response was found and in 43% of the patients with locally advanced disease complete or partial responses were noted. The median progression-free survival rate for both groups was 9.5 months.

Basal cell carcinoma begins in the lower part of top layer of the skin (epidermis) on areas of skin that are exposed to ultraviolet radiation. It is mostly a slow growing and painless form of skin cancer. Most skin cancers appear in older people or in people with an weak immune systems. Every year around 1,000,000 of new cases of skin cancers (aside from melanoma) are diagnosed in U.S. and around 1,000 deaths are recorded.

Important Safety Information for Erivedge

“Erivedge can cause a baby to die before it is born (be stillborn) or cause a baby to have severe birth defects based on how the medicine interacts with the body.

• Female patients who can become pregnant should speak with their healthcare provider about the risks of Erivedge to their unborn child. Their healthcare provider should do a pregnancy test within seven days before they start taking Erivedge to find out if they are pregnant. Women should avoid pregnancy by using highly effective birth control before starting Erivedge, and continue during treatment and for seven months after their last dose. They should tell their healthcare provider right away if they have unprotected sex or think that their birth control has failed. Female patients must tell their healthcare provider right away if they become pregnant or think that they may be pregnant. Pregnant women are encouraged to participate in a program called the Erivedge pregnancy pharmacovigilance program by calling 1-888-835-2555.

• Male patients should always use a condom with a spermicide during sex with female partners while they are taking Erivedge and for two months after their last dose, even if they have had a vasectomy. Male patients should tell their healthcare provider right away if their female partner could be pregnant or thinks she is pregnant while they are taking Erivedge.

• Patients must not donate blood or blood products while they are taking Erivedge and for seven months after their last dose.

• The most common side effects of Erivedge are muscle spasms, hair loss, change in how things taste or loss of taste, weight loss, tiredness, nausea, diarrhea, decreased appetite, constipation, vomiting and joint aches. Another side effect may include missed monthly periods in females who can become pregnant.

• Patients should tell their healthcare provider if they have any side effect that bothers them or that does not go away.

• These are not all the possible side effects of Erivedge. For more information, please see the Full Prescribing Information for Erivedge, including the Boxed WARNING and Medication Guide.”