Roche Holdings Ltd. (Other OTC:RHHBY.PK - News) recently announced that the US Food and Drug Administration (:FDA) has approved its skin cancer drug Erivedge (vismodegib) for the treatment of patients with advanced basal cell carcinoma (:BCC). The once-daily oral drug is approved for use in patients whose cancer has relapsed after surgery or whose cancer has spread to other parts of the body or who cannot be treated with surgery or radiation.
We note that Roche had submitted the new drug application (:NDA) for Erivedge in September 2011 on the basis of results from the ERIVANCE BCC study, which enrolled 104 patients with advanced BCC, including 71 patients with locally advanced BCC (laBCC) and 33 patients with metastatic BCC (mBCC).
The study demonstrated that Erivedge substantially shrank tumors in 43% of patients with laBCC and 30% of patients with mBCC. The median duration of progression-free survival (NYSE:PFS - News) was 9.5 months.
Roche has a collaboration agreement with Curis Inc. (NasdaqGM:CRIS - News) for Erivedge. According to the agreement, Roche is responsible for developing and commercializing the drug worldwide, excluding Japan, where Chugai Pharmaceuticals is responsible.
Curis is eligible to receive payments upon the achievement of certain clinical development and regulatory milestones. Curis will also receive royalties upon commercialization of Erivedge.
BCC is a form of skin cancer, which, in an advanced form, can cause disfiguring and debilitating effects that could ultimately prove fatal. The disease is generally curable if the cancer affects only a small area of the skin. However, if the disease is left untreated or does not respond to treatment, the cancer may spread further. In such cases, it becomes life-threatening.
We currently have a Zacks #3 Rank (short-term Hold rating) on Roche.
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