Genentech/Biogen Idec expanded their Rituxan (rituximab) oncology portfolio with FDA approval of two new indications for low-grade or follicular, CD-20-positive, B-cell Non-Hodgkin's lymphoma, the companies announced Sept. 29.

The first new Rituxan indication is for first-line treatment of previously untreated patients with follicular NHL in combination with CVP chemotherapy. The second is for ongoing treatment of patients "with stable disease or who achieve a partial or complete response following first-line treatment with CVP."

Genentech noted that Rituxan has a dedicated oncologic sales force, but could not say how the new indications would affect the company's marketing strategy. For the new first-line indication, the drug has a wholesale acquisition cost of approximately $19,561, assuming an average course of six doses. For the second indication, the cost is approximately $52,154 for two years, or approximately 16 doses.

In a 322-patient clinical study to evaluate the first-line use of Rituxan with CVP, median progression-free survival was 2.4 years with rituximab versus 1.4 years for CVP alone, the companies said.

All patients received up to eight three-week cycles of CVP; patients in the Rituxan plus CVP arm received Rituxan 375 mb/m2 on day one of each treatment cycle. The regimen also reduced the risk of disease progression, relapse or death by 56% compared to CVP alone.

For the second new indication, 322 patients with stable disease or partial or complete response following first-line treatment, were put into two groups: Rituxan 375 mg/m2 given in four weekly infusions every six months for up to 16 doses, or observation. Rituxan reduced the risk of disease progression relapse or death by more than 50%.

Rituxan was approved in 1997 as a single agent for patients with relapsed or refractory, low-grade or follicular CD-20-positive, B-cell NHL. The WAC on that treatment is approximately $13,041, assuming four doses.

On Feb. 10, rituximab was approved for first-line use in patients with diffuse large B-cell, CD-20 positive NHL in combination with CHOP or other anthracycline-based chemotherapy regimens (¹ Also see "Rituxan Approved For First-Line Non-Hodgkin's Lymphoma" - Pink Sheet, 13 February, 2006.). The cost for this treatment is approximately the same as for the new front-line indication, at $19,561, assuming an average of six doses.

The therapeutic antibody also is in studies for other hematologic malignancies, as well as autoimmune diseases with significant unmet needs, including systemic lupus erythematosus, lupus nephritis, multiple sclerosis and ANCA-associated vasculitis, the companies said.

On Feb. 28, FDA approved Rituxan for use in combination with methotrexate to treat adults with moderately-to-severely active rheumatoid arthritis (² Also see "Rituxan Comes In Like A Lion With Two New Indications" - Pink Sheet, 1 March, 2006.).

Rituxan also is being evaluated in an ongoing Phase III study for treatment of relapsed or refractory chronic lymphocytic leukemia, and it is in Phase II for relapsing-remitting multiple sclerosis (³ Also see "Rituxan Is On Target (Price Wise) As Multiple Sclerosis Treatment" - Pink Sheet, 7 September, 2006.).

-Shirley Haley (s.haley@elsevier.com)

Rituxan Adds Third NHL Indication In 2006

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