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Roche scores conditional European win with Erivedge

Authored by Karl Simpson

Genentech continues to make advances in the area of oncology, firstly through the widely spoken of data that came out of ASCO surrounding their cancer immunotherapies antibody product development (MPDL3280A) which will rival both Merck and BMS in (PD-1) melanoma, although not exclusively in this indication.

Now the company, through its licensing deal with Curis Inc., has gained conditional approval from the European Commission for Erivedge® (vismodegib) for the treatment of adult patients with symptomatic metastatic basal cell carcinoma (BCC) or locally advanced BCC unsuitable for surgery or radiotherapy.

Conditional approval, or conditional marketing authorization, granted by the European Medicines Agency is something industry commentators are calling for more use of as a bridge towards adaptive licensing. It is granted to medicines which show positive benefit/risk assessment and satisfy an unmet medical need thereby benefiting public health. Its status often carries certain follow on commitments by the company to provide additional data once the product is being used by patients. These characteristics make it particularly useful in diseases areas where patient recruitment in clinical trials is challenging because of small patient populations, such as rare diseases.

Genentech (or Roche), will also have post approval commitment and is being asked by the commission to provide additional data on Erivedge in advanced BCC from an ongoing global safety study. The commission grated the conditional approval on the recommendation of the CHMP earlier in 2013. The green light by the EMA initiated a milestone payment to Curis from Roche of $6m and the company will continue to receive royalties on future sales of Erivedge. Roche will be responsible for the commercialisation in Europe.

Erivedge was given FDA approval in January 2012 after a priority review and has subsequently gained approval in Switzerland, Australia, Israel, South Korea, Mexico, and Ecuador. Curis continues to develop other cancer therapies, including CUDC-247 a small molecule antagonist of IAP proteins, and CUDC-907, a dual PI3K and HDAC inhibitor.

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