Erivedge (vismodegib) was approved today by the U.S. FDA for the treatment of basal cell carcinoma (BCC), the most common form of skin cancer.
Erivedge is a prescribed for use once-a-day by people with basal cell carcinoma that has spread elsewhere in the body or who are not candidates for the surgery or radiation treatment ordinarily used to treat this form of skin cancer.
In a story published in the New York Times, the wholesale price of Erivedge will be $7,500 a month, or about $75,000 for the 10-month course of treatment that was typical in the clinical trial.
The FDA announced that the approval was based on an analysis of 96 patients in a clinical trial with locally advanced or metastatic basal cell carcinoma. In the study, Erivedge shrank the tumors in 30% of those with metastatic cancer and shrank or eliminated tumors in 43% of patients with locally advanced cancer.
The approval by the FDA followed a priority review program that provides for expedited review of drugs perceived to represent major therapeutic advances. The active ingredient of Erivedge, vismodegib, stops the “hedgehog signal” that is required for the growth of basal cell skin cells.
Erivedge is being made available with a important safety warning. This “black box” warning points out that Erivedge cannot be used by women who are pregnant because it may lead to the death of the baby (stillbirth) or cause severe birth defects.
For females who can become pregnant:
- You should talk with your healthcare provider about the risks of Erivedge to your unborn child.
- Your healthcare provider should do a pregnancy test within 7 days before you start taking Erivedge to find out if you are pregnant.
- In order to avoid pregnancy, you should start using highly effective birth control before you start Erivedge, and continue to use highly effective birth control during treatment, and for 7 months after your last dose of Erivedge. Talk with your healthcare provider about what birth control method is right for you during this time.
- Talk to your healthcare provider right away if you have unprotected sex or if you think that your birth control has failed.
- Tell your healthcare provider right away if you become pregnant or think that you may be pregnant.
- You should always use a condom with a spermicide, even if you have had a vasectomy, during sex with female partners while you are taking Erivedge and for 2 months after your last dose to protect your female partner from being exposed to Erivedge.
- Tell your healthcare provider right away if your partner becomes pregnant or thinks she is pregnant while you are taking Erivedge.