A New Formulation for Rituxan Moves Ahead With FDA Committee Vote

All members of the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted to approve Rituxan for the treatment of some blood cancers.
BY JASON M. BRODERICK @jasoncology
PUBLISHED: MARCH 29, 2017
In a unanimous (11-0) vote, the FDA’s Oncologic Drugs Advisory Committee (ODAC) recommended the approval of subcutaneous Rituxan for the treatment of patients with certain blood cancers, according to Genentech, the manufacturer of the treatment.

The company explained in a statement that the novel co-formulation includes the identical monoclonal antibody as intravenous (IV) Rituxan (rituximab), along with the molecule hyaluronidase, which facilitates the delivery of medicine beneath the skin.

The proposed indications for the treatment include previously untreated follicular lymphoma (FL), 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). A final approval decision is expected from the FDA by June 26, 2017.

“Subcutaneous rituximab can be administered in five to seven minutes compared to an hour and a half or more for intravenous Rituxan,” Sandra Horning, M.D., chief medical officer and head of Global Product Development at Genentech, said in a statement. “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.”

ODAC based its recommendation on a review of data from five clinical trials that included 2,000 patients with the various blood cancers for which rituximab IV is currently approved. The results demonstrated that the efficacy, safety, and pharmacokinetics of the subcutaneous (SC) formulation were noninferior to IV Rituxan.

The specific trials included in the clinical development program were as follows:  SparkThera (NCT00930514), a phase 1b maintenance study in previously untreated or relapsed follicular lymphoma; SABRINA (NCT01200758), a phase 3 induction and maintenance study in previously untreated follicular lymphoma; SAWYER (NCT01292603), a phase 1b study in previously untreated CLL; MabEase (NCT01649856), a phase 3 study in previously untreated DLBCL; and PrefMab (NCT01724021), a phase 3 patient preference study in previously untreated follicular lymphoma and DLBCL.



Talk about this article with other patients, caregivers, and advocates in the Leukemia CURE discussion group.
x-button
Special Feature
Share Your Art
Related Articles
3 Times Cancer Was Fun
Cobra, baseball cards and two guys who always let me know I wasn't dead.
CAR T-Cell Therapy Yescarta Approved to Treat Non-Hodgkin Lymphoma
Yescarta was granted FDA approval for use in adults with relapsed or refractory non-Hodgkin lymphoma. This is only the second CAR T-cell therapy ever approved.
New Hodgkin Lymphoma Therapy in the Pipeline
Adcetris (brentuximab vedotin) was granted a breakthrough therapy designation by the Food and Drug Administration (FDA) for the frontline treatment of patients who have classical Hodgkin lymphoma
Related Videos
Cancer Survivor Celebrates by Dancing with Scripps Doctor
Irene Hutchins, M.D., and her patient Steve Valentine, both accomplished ballroom dancers, made a pact to dance together once he had recovered from late-stage Burkitt lymphoma. They performed their victory dance June 11 during Cancer Survivors Day at Scripps Green Hospital, in La Jolla, California, where Hutchins treated Valentine.
Aziz Nazha on Adverse Events Associated With Treatment for MDS
Aziz Nazha, Hematology and Medical Oncology Fellow, Cleveland Clinic, discusses adverse events associated with treatment for myelodysplastic syndrome (MDS).
Aziz Nazha Discusses the Future of Treating Patients With MDS
Aziz Nazha, Hematology and Medical Oncology Fellow, Cleveland Clinic, discusses the future of treating patients with myelodysplastic syndrome (MDS).
x
//For side ad protocol