RxTrials Institute Drug Pipeline Alert

Genentech will submit an sBLA this year for accelerated FDA approval to use its oncology drug Avastin to treat relapsed glioblastoma multiforme (GBM). The application will be based on results from a Phase II clinical trial.

The company said it plans to start a Phase III study of Avastin (bevacizumab) for first-line treatment of metastatic GBM. The drug is approved to treat metastatic colorectal cancer, nonsmall cell lung cancer and metastatic breast cancer in combination with other drugs.

Separately, Genentech and its partner Curis plan to study a systemic hedgehog antagonist molecule in Phase II clinical trials. (The term hedgehog defines a molecule that affects fruit fly development and has an analogue in human beings; fruit fly embryos that lack it are covered with tiny bristles, like hedgehogs). The molecule will be studied as a treatment for metastatic colorectal cancer, advanced basal cell carcinoma and other advanced solid tumors. The company said it is entering two new therapeutic areas —  neuroscience and infectious disease.