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Genentech Receives 13th FDA Breakthrough Therapy Designation

May 16, 2013

Genentech announces on May 15, 2013, that orphan drug Obinutuzumab receives FDA Breakthrough Therapy Designation #13 for Chronic Lymphocytic Leukemia (CLL). It is estimated that there will be about 5,000 deaths from CLL in 2013, in the US.

A Phase III study (CLL11) shows that Obinutuzumab significantly reduces the risk of disease progression or death in patients with CLL. The Phase III data is to be presented at the annual meeting of the American Society of Clinical Oncology (ASCO), May 31 – June 4, 2013, in Chicago. The study compares the combination of either Obinutuzumab or Rituxan (Rituximab) and Chlorambucil (chemotherapy), to Chlorambucil alone in patients with CLL. Obinutuzumab + Chlorambucil shows a “significant 86% reduction in the risk of disease progression, relapse, or death. Additionally, the length of time during which people lived without their disease worsening was more than doubled when compared to Chlorambucil alone.”

In April 2013, Pharmacyclics and Janssen Research & Development’s cancer therapy orphan drug Ibrutinib receives FDA Breakthrough Therapy Designation for CLL.

Please Note: FDA Official Logo from FDA website.

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