Rituxan holds off leukemia progress

Genentech and Biogen Idec are crowing today about Rituxan's performance in a leukemia trial. The late-stage research found that Rituxan in combo with two chemo drugs "significantly" boosted progression-free survival for patients who had relapsed with chronic lymphocytic leukemia. The trial data is now under independent review, the companies said, "for U.S. regulatory purposes."

In other words, expect an application for broader Rituxan use. "We look forward to collaborating with Biogen Idec to discuss these data with the FDA in the future," Genentech's SVP Dr. Hal Barron said in a statement.

Rituxan is now approved to combat rheumatoid arthritis and non-Hodgkins' lymphoma. Earlier this year, another late-stage study found that a similar Rituxan combo improved progression-free survival in leukemia patients who hadn't been previously treated. So the companies have promising data in both untreated patients and relapsed patients. We'll keep our eyes open for FDA action.

- read the joint release
- see the Associated Press article

Suggested Articles

Compared with the FDA "boxed warning," the EMA version puts a smaller restriction on the higher dose but broadens the cautionary language.

Shionogi's newest antibiotic Fetroja has now earned the FDA's approval, but will a mortality-rate warning scuttle the drug's chances?

Novartis' Sandoz doubled down in Japan as Lupin retreated. Dr. Reddy's posted a loss tied to its Zantac recall. Aslan's varlitinib failed again.