Two New Indications Approved for Rituximab in NHL

The US Food and Drug Administration (FDA) has approved, after a priority review, two additional uses for rituximab (Rituxan) for patients with CD20-positive, B-cell non-Hodgkin's lymphoma (NHL). One new indication is for first-line treatment of previously untreated patients with follicular NHL in combination with CVP (cyclophosphamide, vincristine, and prednisolone) chemotherapy. The second new indication is for the treatment of low-grade NHL in patients with stable disease or who achieve a partial or complete response following first-line treatment with CVP chemotherapy.

Delaying Progression

"The goal of treating low-grade or follicular NHL, a chronic cancer marked by multiple recurrences, is to delay disease progression for as long as possible," said Howard Hochster, MD, professor of medicine and clinical pharmacology, New York University 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 trial, the use of extended Rituxan dosing following induction CVP chemotherapy in patients who reached stable disease or better has been shown to decrease the risk of disease progression, relapse or death."

In February 2006, rituximab in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) or other anthracycline-based chemotherapy was approved as first-line treatment for patients with diffuse large B-cell lymphoma (DLBCL). Rituximab was approved in 1997 as a single agent for patients with relapsed or refractory, low-grade or follicular CD20-positive B-cell NHL.

Clinical Studies

The FDA approval of rituximab as a first-line treatment in previously untreated patients with follicular, CD20-positive B-cell NHL in combination with CVP chemotherapy is based on data from a phase III, randomized, controlled study of 322 patients. The study evaluated the first-line use of rituximab in combination with CVP chemotherapy (R-CVP) vs CVP chemotherapy alone. All patients received up to eight 3-week cycles of CVP chemotherapy. Patients in the R-CVP arm received rituximab, 375 mg/m², on day 1 of each treatment cycle. Study results included the following findings:

• R-CVP improved median progression-free survival to 2.4 years from 1.4 years for CVP chemotherapy alone.

• R-CVP reduced the risk of disease progression, relapse, or death by 56% compared to CVP chemotherapy alone (hazard ratio = 0.44; P < .0001).

The FDA approval of rituximab for the treatment of low-grade, CD20-positive, B-cell NHL in patients with stable disease or who achieve a partial or complete response following first-line treatment with CVP chemotherapy, is based on a phase III, randomized, controlled Eastern Cooperative Oncology Group study of 322 patients. Study participants received rituximab, 375 mg/m^{2, given in four weekly infusions, every 6 months for up to 16 doses, or observation. Rituximab reduced the risk of disease progression, relapse, or death by more than 50% over observation.}