FDA: Breakthrough Therapy Drug Approved for CLL

The FDA has approved Gazyva (obinutuzumab; Genentech) for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia (CLL).

Obinutuzumab (GA101) is the first type II anti-CD20 medicine that is glycoengineered, which creates a unique antibody designed to act as an immunotherapy, engaging the patient's own immune system to help attack the cancerous cells. In addition, GA101 binds to CD20 with the aim of inducing direct cell death.

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The approval is based on the findings of the Phase 3 CLL11 trial. The study showed that patients who received Gazyva in combination with chlorambucil chemotherapy had significantly reduced risk of disease progression or death (HR=0.16; P<0.0001) and lived significantly longer without their disease getting worse compared to those who received chlorambucil alone (median PFS 23.0 months vs. 11.1 months).

Gazyva was granted Breakthrough Therapy designation due to the significance of the positive results from its Phase 3 CLL 11 trial and the serious and life-threatening nature of CLL.

Gazyva will be available in a 1000mg/40mL (25mg/mL) strength as a single-use vial in approximately two weeks.

For more information call (800) 821-8590 or visit Gazyva.com.

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