ROCKVILLE, Maryland—Rituxan (rituximab, Genentech/Biogen Idec) has been approved for two new indications in patients with CD20-positive, B-cell non-Hodgkin’s lymphoma. After an accelerated review, FDA approved Rituxan for the first-line treatment of previouslyuntreated patients with follicular NHL in combination with cyclophosphamide(Drug information on cyclophosphamide), vincristine, and prednisone(Drug information on prednisone) (CVP) and for use in low-grade NHL patients with stable disease or who have achieved a partial or complete response following first-line treatment with CVP.
“These approvals are the result of an extraordinary collaboration between Biogen Idec, Genentech, the Eastern Cooperative Oncology Group, clinical investigators, the FDA, and most importantly, the patients who participated in the clinical trials,” said Hal Barron, MD, Genentech’s senior vice president for development and chief medical officer.
An estimated 360,000 Americans are currently living with NHL, and physicians diagnose more than 58,000 new cases each year. Approximately 85% of NHL cases involve B-cells, and 30% of NHL patients have slow-growing but incurable (low-grade) disease.
Rituxan is a genetically engineered murine/human monoclonal antibody, which binds specifically to the CD20 antigen found on normal and malignant B lymphocytes. This binding results in cell lysis. The drug initially received FDA approval in 1997 as a single agent for patients with relapsed or refractory, low-grade or follicular CD20-positive, B-cell NHL. Earlier this year, the agency approved Rituxan, in combination with CHOP or other anthracycline-based chemotherapies, as a first-line treatment for patients with diffuse large B-cell lymphoma (DLBCL).
Delay Disease Progression “The goal of treating low-grade or follicular NHL . . . is to delay disease progression for as long as possible,” said Howard Hochster, MD, professor of medicine and clinical pharmacology, New York University’s School of Medicine and Cancer Institute. “These approvals enable doctors and patients to select among different treatment options with Rituxan in the front-line setting. As we demonstrated in the Eastern Cooperative Oncology Group [ECOG] trial, the use of extended Rituxan dosing following induction of CVP chemotherapy in patients who reached stable disease or better has been shown to decrease the risk of disease progression, relapse, or death.”
FDA approved the first-line use of the drug in previously untreated follicular, CD20-positive, B-cell NHL patients based on findings of a phase III controlled, multicenter open-label study of 322 patients randomized to receive up to eight 3-week cycles of CVP alone or in combination with Rituxan 375 mg/m2 on the first day of each cycle.
An independent review found a significantly increased progression-free survival for the Rituxan/CVP patients, 2.4 years vs 1.4 years for those receiving CVP alone. Rituxan/CVP reduced the risk of disease progression, relapse, or death by 56%, compared with CVP alone (P < .0001).