Roche Holdings Ltd. (RHHBY) recently announced that the US Food and Drug Administration (FDA) has accepted its new drug application (NDA) for vismodegib for review. The company is seeking approval of vismodegib for the treatment of patients with advanced basal cell carcinoma (BCC), whose lesions could not be operated or for whom surgery would result in substantial deformity.
The regulatory body has agreed to review the NDA, submitted in September 2011, on a priority basis. A response from the FDA is expected to be out by March 8, 2012.
The NDA submission by Roche was based on results from the ERIVANCE BCC study. The study, which reported data in June 2011, 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 vismodegib substantially shrank tumors or healed visible lesions in 43% of patients with laBCC and 30% of patients with mBCC. The median duration of progression-free survival (PFS) was 9.5 months.
Roche has a collaboration agreement with Curis Inc. (CRIS) for vismodegib. According to the agreement, Roche is responsible for developing and commercializing vismodegib 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 vismodegib.
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 #4 Rank (short-term Sell rating) on Roche.
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