Erivedge Prescribing Information

(ChemotherapyAdvisor) – The U.S. Food and Drug Administration (FDA) today approved oral Erivedge (vismodegib), manufactured by Genentech, for the treatment of adult patients with locally advanced basal cell carcinoma who are not candidates for surgery or radiation and for those with metastatic disease.

Vismodegib is the first FDA-approved agent for metastatic basal call carcinoma. The FDA expedited its review of vismodegib, which inhibits the Hedgehog molecular pathway. A vismodegib capsule is taken once daily.

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Efficacy and safety of vismodegib was evaluated in a pivotal international, single-arm, multicenter, two cohort, open-label phase II trial in 96 patients. The primary end point, objective response rate, was achieved in 43% of patients (27 of 63) with locally advanced disease (complete or partial response) and 30% (10 of 33) of those with metastatic disease (all partial responses). Median duration of response was 7.6 months.

Muscle spasms, hair loss, weight loss, nausea, diarrhea, fatigue, distorted sense of taste, decreased appetite, constipation, vomiting, and loss of taste function in the tongue were the most common adverse events.

According to the FDA, vismodegib is being approved with a Boxed Warning alerting of the potential risk of embryo-fetal death and severe birth defects. Pregnancy status must be verified prior to treatment initiation. Male and female patients should be warned about these risks and the need for contraception.

Vismodegib, marketed by Genentech, a member of the Roche Group, will be available in the U.S. within a week or two of approval and distributed through specialty pharmacies.