Genentech announced that the Food and Drug Administration (FDA)’s Oncologic Drugs Advisory Committee (ODAC) voted (11-0) that the benefit-risk of rituximab/hyaluronidase for subcutaneous (SC) injection was favorable for the treatment of certain hematologic cancers.
These cancers 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)
This novel co-formulation combines rituximab (Rituxan) and recombinant human hyaluronidase (rHuPH20), a molecule that helps deliver the drug subcutaneously. Compared to intravenous (IV) Rituxan that can take 1.5–4 hours for administration, the SC formulation can be administered in 5–7 minutes.
The ODAC recommendation was supported by data from a clinical development program consisting of five studies that included >2,000 patients across major blood cancers for which IV Rituxan is approved. Clinical studies linking the safety and efficacy profile of the SC formulation to the already established IV Rituxan were included. In the studies, the SC co-formulation demonstrated non-inferior levels of rituximab in the blood and produced consistent clinical efficacy and safety outcomes vs. IV Rituxan. In addition, data from various Phase 1b and 3 studies evaluating patient preferences and healthcare professional opinions for SC rituximab were also included in the Biologics License Application (BLA) submitted to the FDA.
Rituxan, a CD20-directed cytolytic antibody, is currently approved as an IV drug to treat previously untreated follicular lymphoma, previously untreated DLBCL, relapsed or refractory low grade or follicular lymphoma, and previously untreated and relapsed or refractory CLL. The IV formulation will continue to be available to patients if the SC rituximab formulation is approved.
The FDA is expected to decide on the SC co-formulation by June 26, 2017.
For more information call (888) 835-2555 or visit Rituxan.com.