Pharma Strategy Blog

Commentary on Pharma & Biotech Oncology / Hematology New Product Development

Posts tagged ‘Hedgehog inhibitor’

FDA approves Roche hedgehog inhibitor vismodegib/Erivedge in basal cell carcinoma

It’s been quite a roller coaster ride for Hedgehog inhibitors of late.

infinity logo FDA approves Roche hedgehog inhibitor vismodegib/Erivedge in basal cell carcinomaLast week, brought negative data as Infinity announced that their phase II trial with saridegib (IPI-926) had been stopped for futility in pancreatic cancer.  This trial sought to determine the impact of the hedgehog in combination with gemcitabine over gemcitabine alone in advanced pancreatic cancer.  Unfortunately, the trial was stopped for futility, meaning the control arm was doing better than the treatment arm.

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Roche files vismodegib for basal cell carcinoma with FDA

Good news this morning as Roche announced that their Hedgehog (Hh) inhibitor licensed from Curis, GDC-0449 (now known as vismodegib), has been submitted to the FDA for the treatment of advanced basal cell carcinoma (BCC) in patients for whom surgery is not appropriate.

The filing is based on phase II data from the ERIVANCE (BCC/SHH4476g) phase II trial that was reported earlier this year at the American Association of Cancer Research (AACR) meeting. The pivotal trial was a single arm study with the design based on discussions with the FDA, since there are no approved therapies for this setting. In other words, these are refractory patients with advanced disease.

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