Genentech Seeks FDA Clearance for Next Skin Cancer Drug

Xconomy San Francisco — 

Genentech is shipping off its latest application to the FDA to start selling a new cancer drug. This morning, the South San Francisco-based unit of Roche said it has filed paperwork for U.S. approval of vismodegib, a new drug for people with a deadly type of skin cancer that can’t be surgically removed.

The drug, which Genentech developed in collaboration with Lexington, MA-based Curis (NASDAQ: CRIS), was shown to significantly shrink tumors in 43 percent of patients who had basal cell carcinoma that had spread in the vicinity of a skin lesion, and for 30 percent of patients whose disease had spread throughout the body, according to results from a pivotal study released in June. The most common side effects were muscle spasms, hair loss, altered taste sensation, weight loss, fatigue, nausea, decreased appetite and diarrhea, Genentech said. Most cases of basal cell carcinoma are curable, when the lesion is surgically removed.

Scientists will be watching how this drug performs with some interest. The compound, an oral pill, is designed to inhibit a biological pathway known as hedgehog. When it becomes abnormally activated, it can send signals that help tumors to grow. Problems in the pathway are thought to be linked to 90 percent of cases of basal cell carcinoma, and to play a role in a number of other tumor types.

Last month, Genentech won FDA approval for another new cancer drug, vemurafenib (Zelboraf) for patients with a different kind of skin cancer that has spread through the body—metastatic melanoma. That drug was developed in partnership with Berkeley, CA-based Plexxikon, now part of Daiichi Sankyo.

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