FDA grant breakthrough Therapy Designation to GA 101 (Roche) for CLL

The FDA has granted GA 101 (obinutuzumab), from Roche, Breakthrough Therapy Designation for treating CLL. This designation is designed to expedite the development and review of medicines intended to treat serious diseases and to help ensure patients have access to them through FDA approval as soon as possible. The agency has set an action date of Dec. 20 2013 for the drug.

The FDA is evaluating Phase III date which show the drug has significant benefits: progression-free survival was 23 months for obinutuzumab plus chemo, compared to 10.9 months for another arm receiving Rituxan and chemo. Marketing applications have also been submitted to other regulatory authorities, including the EMA.