FDA approves benefit-risk ratio for Genentech blood cancer drug

The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) voted 11-0 on a favorable benefit-risk ratio for Genentech's rituximab/hyaluronidase subcutaneous injections in treating certain blood cancers.
Blood cancers for which the injections would help, according to the vote, include previously untreated follicular lymphoma, previously untreated diffuse large B-cell lymphoma (DLBCL), relapsed or refractory low grade or follicular lymphoma, and previously untreated and relapsed or refractory chronic lymphocytic leukemia (CLL).
Genentech’s Rituxan has the same co-formulation. The FDA should make a decision on whether to approve Rituxan by June 26. The co-formulation is already available in the European Union, and as has been since 2014, under the name of MabThera.
“Subcutaneous rituximab can be administered in five to seven minutes compared to an hour and a half or more for intravenous Rituxan,” Dr. Sandra Horning, chief medical officer and head of global product development, said. “The significant reduction in administration time could especially benefit people with blood cancer who may receive years of treatment, and we are pleased the committee unanimously supported this new co-formulation.”