NEW YORK (AP) — Biogen Idec Inc. and Genentech said Friday that the FDA has approved an additional use for blockbuster cancer drug
Rituxan as a first-line maintenance treatment for patients with follicular
lymphoma, a cancer of the blood.
Biogen and Genentech, which is part of Swiss pharmaceutical firm Roche Group, said the disease is considered
incurable and is characterized by years of relapses and remissions. An estimated
65,000 people in the U.S. were diagnosed with non-Hodgkin's lymphoma last year,
and follicular lymphoma accounted for up to a fifth of those cases. The disease
can occur at any time during adulthood, though people are typically diagnosed
during their 50s and 60s.
The approval announced Friday is for the drug's use as a maintenance
treatment for patients with previously untreated advanced follicular lymphoma
who responded to initial treatment with a combination of Rituxan and
chemotherapy. In data submitted to regulators, the drug nearly doubled the
length of time people lived without the disease getting worse.
The European Union cleared the drug for the same indication in October.
Rituxan, discovered by Biogen Idec of Weston, Mass., first received FDA
approval in 1997 for the treatment of non-Hodgkin's lymphoma. Genentech and
Biogen collaborate on Rituxan in the U.S., and Roche markets the drug elsewhere
in the world except in Japan, where Rituxan is co-marketed by Chugai and Zenyaku
Kogyo Co. Ltd.
A biologic drug produced in living cells, it is Roche's second-bestselling
medicine, with global sales of about $5.9 billion in 2009.