FDA Grants Priority Review to Genentech’s Anti-Cancer Drug

August 28, 2017

Genentech gets priority review for its application seeking a new indication for its anti-cancer drug, Gazyva (obinutuzumab), in treating follicular lymphoma.

Genentech, a member of the Roche Group, announced on August 27, 2017 that FDA has accepted the company’s supplemental biologics license application (sBLA) and granted priority review for Gazyva (obinutuzumab) in combination with chemotherapy followed by Gazyva alone for treating previously untreated follicular lymphoma, a common blood cancer. Follicular lymphoma, a slow-growing (indolent) form of non-Hodgkin’s lymphoma, is incurable and characterized by cycles of remission and relapse.

The sBLA is based on results of a Phase III study in previously untreated follicular lymphoma to show better progression-free survival over Rituxan (rituximab)-based treatment, the current standard of care by Roche. FDA is expected to make a decision on approval under priority review by Dec. 23, 2017. Priority review designation is granted to medicines that FDA has determined to have the potential to provide significant improvements in the safety and effectiveness of the treatment, prevention, or diagnosis of a serious disease. Additional submissions of the Phase III study data to health authorities around the world are ongoing.

“Follicular lymphoma becomes harder to treat each time it returns, and the goal of initial treatment is to prevent the cancer from progressing for as long as possible,” said Sandra Horning, MD, chief medical officer and head of Global Product Development at Genentech, in a company press release. “Based on the [Phase III] study, Gazyva-based treatment significantly improved progression-free survival over the current standard of care, and we are committed to bringing this potential new option to patients as soon as possible.”

Gazyva is an engineered monoclonal antibody designed to attach to CD20, a protein found on certain types of B-cells. It is thought to work by attacking targeted cells both directly and together with the body's immune system. Gazyva was discovered by Roche Glycart AG, a wholly owned, independent research unit of Roche. In the United States, it is part of a collaboration between Genentech and Biogen.

Gazyva was approved by FDA in November 2013 for use in combination with chlorambucil to treat previously untreated chronic lymphocytic leukemia. Combination studies investigating its use with other approved or investigational medicines, including cancer immunotherapies and small molecule inhibitors, are planned or underway across a range of blood cancers.

Source: Genentech