Genentech drug for FDA approval next-skin-cancer Drug ? Xconomy ...
Luke by Luke Timmerman 09/12/11
Genentech is sending out his latest submission to the FDA to begin 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 form of skin cancer that can not be surgically removed.
The drug, which Genentech in partnership with Lexington, Mass.-developed Curis (NASDAQ: CRIS ) has been shown, , the basal cell carcinoma that had spread in the vicinity of a lesion and spread for 30 percent of patients whose disease in the body, according to results from a pivotal study published in June. The most common side effects were muscle cramps, hair loss, taste changes, weight loss, fatigue, nausea, anorexia and diarrhea, said Genentech. Most cases of basal cell carcinoma are curable if the lesion is removed surgically. scientists will watch how this drug leads with some interest. The compound, an oral pill is designed to inhibit a biological pathway known as hedgehogs. If it is abnormally activated, it can send a signal that help tumors grow. Problems in the way are thought to be linked to 90 percent of cases of basal cell carcinoma and play a role in a number of other tumor types. Last month, Genentech for more new cancer drug, vemurafenib (Zelboraf) for patients with a different type of skin cancer that has spread through the body-metastatic melanoma. The drug was developed in collaboration with Berkeley, Calif.-based Plexxikon recently developed part of Daiichi Sankyo. Luke Timmerman is the editor of National Biotech Xconomy, and the publisher of Xconomy Seattle. E-mail him at ltimmerman@xconomy.com or follow him on Twitter at twitter.com / ldtimmerman .Related Post for Genentech drug for FDA approval next-skin-cancer Drug ? Xconomy
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