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Roche submits vismodegib for FDA approval

Roche's Genentech subsidiary has submitted a new drug application to the US Food and Drug Administration for vismodegib in the treatment of people with advanced basal cell carcinoma who cannot undergo surgery

Roche has submitted a new drug application to the US Food and Drug Administration (FDA) for vismodegib in the treatment of people with advanced basal cell carcinoma (BCC) who cannot undergo surgery.

The application, submitted by Roche's subsidiary Genentech, is based on data from a phase II trial that showed vismodegib significantly shrank tumours or healed visible lesions in 43 per cent of patients with locally advanced BCC (laBCC) and 30 per cent of patients with metastatic BCC (mBCC).

BCC is the most common type of skin cancer, the advanced version of which can lead to disfiguring and debilitating effects and can be life-threatening. There is currently no approved treatment for the advanced, non-operable form of the condition.

In order to provide people who are appropriate candidates access to vismodegib while Genentech discusses next steps with the FDA, the company said it is conducting an expanded patient access study in the US.

Genentech is developing vismodegib under a collaboration agreement with Curis, a specialist firm involved in the development of small molecule drug candidates for cancer. Curis is eligible to receive milestone payments based on the drug's development and regulatory success.

12th September 2011

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