Curis Inc. announced that Erivedge(TM) (vismodegib) capsule was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with a type of skin cancer, called basal cell carcinoma, that has spread to other parts of the body or that has come back after surgery or that their healthcare provider decides cannot be treated with surgery or radiation. It is being developed and will be commercialized by Roche and Genentech, under a collaboration agreement between Curis and Genentech. Curis earned a $10 million milestone payment from Genentech as a result of the FDA's approval of Erivedge in this indication and is also entitled to receive royalties on future sales of the product. BCC is generally considered curable if the cancer is restricted to a small area of the skin. People with advanced BCC have tumors that have spread to other parts of the body (metastasized), or can become disfiguring and invade surrounding tissue (locally advanced). In these cases, the disease cannot be treated with surgery or radiation. Advanced BCC often results in severe deformity or impaired function of the affected organs. The FDA approval of Erivedge is based on results from ERIVANCE BCC (SHH4476g), a pivotal international, single-arm, multicenter, two-cohort, open-label, Phase II study that enrolled 104 patients with advanced BCC, including locally advanced BCC (71) and metastatic BCC (33). The study showed Erivedge shrank lesions (objective response rate, or ORR, the primary endpoint of the study, as assessed by an independent review) in 43% (27/63) of patients with locally advanced BCC and 30% of patients (10/33) with metastatic BCC. The median duration of response was 7.6 months. Patients with locally advanced BCC had lesions that recurred after surgery or were not candidates for surgery (inoperable, or for whom surgery would result in substantial deformity), recurred after radiotherapy, or were not candidates for radiotherapy. Study participants received 150mg Erivedge orally, once daily until disease progression or unacceptable toxicity. 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. For females who can become pregnant: Female patients should talk 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. In order to avoid pregnancy, patients should start using highly effective birth control before they start Erivedge and continue to use highly effective birth control during treatment, and for seven months after their last dose of Erivedge. Patients must talk with their healthcare provider about what birth control method is right for them during this time. Patients must talk to their healthcare provider right away if they have unprotected sex or if they think that their birth control has failed. 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 that collects information about exposure to Erivedge during pregnancy and the effects on the mother and her unborn child. This program is called the Erivedge pregnancy pharmacovigilance program. For males: Male patients should always use a condom with a spermicide, even if they have had a vasectomy, during sex with female partners while they are taking Erivedge and for two months after their last dose to protect their female partner from being exposed to Erivedge. Patients must tell their healthcare provider right away if their partner becomes 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. It is not known if Erivedge passes into breast milk. Patients and their healthcare provider should decide if the patient will take Erivedge or breastfeed. Patients should not do both. 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. Other side effects may include missed monthly periods in females who can become pregnant, low levels of sodium in the blood, low potassium levels, and a higher than normal blood level of urea or other nitrogen containing compounds in the blood. 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.