Genentech, a member of the Roche Group (RHHBY.PK) Monday said the U.S. Food and Drug Administration approved Erivedge capsule for the treatment of adults with basal cell carcinoma, that has spread to other parts of the body or that has come back after surgery or determined as not treatable with surgery or radiation.
According to Genentech, Erivedge or vismodegib is the first FDA-approved medicine for people with advanced forms of the disease, which is the most common skin cancer. Roche and Genentech are also evaluating Erivedge in a Phase II trial in people with operable forms of basal cell carcinoma or BCC.
Erivedge is an oral medicine designed to selectively inhibit abnormal signaling in the Hedgehog pathway. The Hedgehog signaling pathway plays an important role in regulating proper growth and development in the early stages of life and becomes less active in adults. Abnormal Hedgehog signaling is implicated in more than 90 percent of Basal cell carcinoma cases.
Basal cell carcinoma is generally considered curable if the cancer is restricted to a small area of the skin. In rare cases, the lesions invade surrounding tissue, termed as locally advanced condition. They also sometimes spread to other parts of the body, termed as the metastasizing condition of the disease.
In these cases of advanced BCC, the disease cannot be effectively treated with surgery or radiation. Advanced BCC often results in severe deformity or loss of function of affected organs.
Roche has also submitted a marketing authorization application for Erivedge in the European Union. While the authorization is awaited, the company is conducting a Phase II safety study in the EU and other countries that is enrolling patients with advanced BCC.
The FDA approval of Erivedge is based on results from Erivance BCC, 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).
In the locally advanced patients, 27 out of 63 demonstrated objective response rate, or ORR, for a percentage of 43. In metastatic BCC patients, 10 out of 33 achieved the ORR, for a percentage of 30. The median duration of response was 7.6 months.
BCC is the most common type of skin cancer in Europe, Australia and the United States. In advanced BCC, if the disease is left untreated or recurs in the same location after surgery or radiotherapy, it may advance further into surrounding areas such as ears, nose and eyes, bone or other tissues. Some cases of advanced BCC can be disfiguring, and treatment with surgery or radiation can lead to the loss of sensory organs and their functions such as eyesight or hearing.
Roche is developing Erivedge under a collaboration agreement with Curis, Inc (CRIS). Erivedge was discovered by Genentech and jointly validated by Genentech and Curis through a series of preclinical studies.
Curis is eligible to receive cash payments upon the successful achievement of specified clinical development and regulatory approval milestones, as well as royalties upon commercialization of Erivedge.
Erivedge will be available in the United States within one-to-two weeks of approval and will be distributed through specialty pharmacies.
RHHBY.PK is currently trading at $42.33, down $0.79 or 1.83%. Over the past year, the stock traded in a range of $34.02 - $45.65. CRIS is trading at $5.04, down $0.14 or 2.76%, on the Nasdaq, having hit a 52-week high of $5.65 earlier in the day.
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