By Ransdell Pierson
NEW YORK, Dec 7 (Reuters) - Biogen Idec and Roche Holding AG on Monday said their drug Rituxan has prolonged survival among patients with the most common form of adult leukemia, according to data from an ongoing late-stage study.
The favorable finding came from an updated look at data from the Phase III study, now that researchers have followed patients for more than three years, the companies said in a joint release.
The study, sponsored by Roche and conducted by a German research group, involves 817 patients with previously untreated chronic lymphocytic leukemia.
One group of patients in the study received Rituxan in combination with two standard chemotherapy agents, fludarabine and cyclophosphamide. Another group received only the two chemo agents.
Some 87.2 percent of those in the Rituxan-plus-chemo group were alive after 37.7 months of treatment compared with 82.5 percent of those receiving chemo alone, the companies said, noting that median survival has not yet been reached.
Moreover, patients in the Rituxan group have progressed without a worsening of symptoms for a median of 51.8 months, compared to 32.8 months for those receiving chemo alone, the companies said.
Other favorable results from the study were reported last year.
But serious adverse events occurred more frequently among patients taking Rituxan and chemo -- especially blood toxicities and neutropenia, a reduction in a type of infection-fighting cell, according to the data.
Biogen and Roche have submitted data from the study, as well as results from another large trial, to the U.S. Food and Drug Administration in hopes of winning permission to market Rituxan for CLL.
The drugmakers last month said the FDA had declined to approve Rituxan for the new indication, pending final discussions on new wording for the drug's package insert label. The companies said the FDA had not requested any new data to compete its review of the intended new use.
Nearly 90,000 Americans are living with CLL and more than 15,000 new cases will be diagnosed this year, the companies said.
Rituxan was approved more than a decade ago to treat non-Hodgkin's leukemia and was approved in 2006 as a treatment for adults with moderate to severe rheumatoid arthritis.
Roche's Genentech division and Biogen co-market Rituxan in the United States, where the drug garners annual sales of more than $2.5 billion. Roche markets it overseas, under the brand name MabThera.
(Reporting by Ransdell Pierson; editing by Carol Bishopric) Keywords: BIOGEN ROCHE/RITUXAN (Reuters Messaging: ransdell.pierson.reuters.com@reuters.net; 646-223-6034; ransdell.pierson@reuters.com) COPYRIGHT Copyright Thomson Reuters 2009. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
NEW YORK, Dec 7 (Reuters) - Biogen Idec and Roche Holding AG on Monday said their drug Rituxan has prolonged survival among patients with the most common form of adult leukemia, according to data from an ongoing late-stage study.
The favorable finding came from an updated look at data from the Phase III study, now that researchers have followed patients for more than three years, the companies said in a joint release.
The study, sponsored by Roche and conducted by a German research group, involves 817 patients with previously untreated chronic lymphocytic leukemia.
One group of patients in the study received Rituxan in combination with two standard chemotherapy agents, fludarabine and cyclophosphamide. Another group received only the two chemo agents.
Some 87.2 percent of those in the Rituxan-plus-chemo group were alive after 37.7 months of treatment compared with 82.5 percent of those receiving chemo alone, the companies said, noting that median survival has not yet been reached.
Moreover, patients in the Rituxan group have progressed without a worsening of symptoms for a median of 51.8 months, compared to 32.8 months for those receiving chemo alone, the companies said.
Other favorable results from the study were reported last year.
But serious adverse events occurred more frequently among patients taking Rituxan and chemo -- especially blood toxicities and neutropenia, a reduction in a type of infection-fighting cell, according to the data.
Biogen and Roche have submitted data from the study, as well as results from another large trial, to the U.S. Food and Drug Administration in hopes of winning permission to market Rituxan for CLL.
The drugmakers last month said the FDA had declined to approve Rituxan for the new indication, pending final discussions on new wording for the drug's package insert label. The companies said the FDA had not requested any new data to compete its review of the intended new use.
Nearly 90,000 Americans are living with CLL and more than 15,000 new cases will be diagnosed this year, the companies said.
Rituxan was approved more than a decade ago to treat non-Hodgkin's leukemia and was approved in 2006 as a treatment for adults with moderate to severe rheumatoid arthritis.
Roche's Genentech division and Biogen co-market Rituxan in the United States, where the drug garners annual sales of more than $2.5 billion. Roche markets it overseas, under the brand name MabThera.
(Reporting by Ransdell Pierson; editing by Carol Bishopric) Keywords: BIOGEN ROCHE/RITUXAN (Reuters Messaging: ransdell.pierson.reuters.com@reuters.net; 646-223-6034; ransdell.pierson@reuters.com) COPYRIGHT Copyright Thomson Reuters 2009. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.