Genentech files for wider Rituxan use

Biotech companies Genentech Inc. and Biogen Idec Inc. and Swiss drug maker Roche said Wednesday that they filed a supplemental application with the Food and Drug Administration to expand the label for Rituxan to treat a larger population of people with non-Hodgkins lymphoma.



The companies said they have requested a priority review from the FDA. If granted, the agency would decide on the supplemental application within six months rather than the standard 10 months.



Rituxan is currently approved as a treatment for low-grade non-Hodgkins lymphoma patients who have failed other therapies or who have relapsed. The supplemental application seeks to expand Rituxan's labeling to be used as a front-line, or first, treatment used in combination with other chemotherapy regimens for patients with intermediate or aggressive forms of the disease.



The application included clinical data from 1,854 previously untreated patients and used overall survival as a primary endpoint. The companies are also studying Rituxan as a treatment for rheumatoid arthritis, a condition when the immune system inappropriately attacks joint tissue, causing inflammation and destroying cartilage, tendons and bones, often resulting in disability.

Blog Category: 

More Articles

More Articles

The US Food and Drug Administration (FDA) has granted a third so-called Breakthrough Therapy Designation for the investigational oral...

The US Food and Drug Administration today has approved an expanded use of Imbruvica (ibrutinib) in patients with...

The U.S. Food and Drug Administration has announced that it has granted "Breakthrough Therapy Designation" for the investigational agent...

According to a new study published in the Proceedings of the National Academy of Sciences, a team from the University of California, San...

Pharmacyclics has announced that the company has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for...

New research suggests that frontline radioimmunotherapy...

Gilead Sciences has announced results of the company's Phase II study of its investigational compound idelalisib, an oral inhibitor of...

In a large trial of older, newly diagnosed patients with chronic lymphocytic leukemia (CLL),...

Today’s typical treatments have been unable to cure numerous types of lymphoma, but emerging immunotherapies could provide the key to...

Biotech firm Gilead Sciences Inc. has announced that the first patient has been dosed in a Phase III trial evaluating the safety and efficacy of...

Last week at the 54th American Society of Hematology Annual Meeting and Exposition in Atlanta, researchers out of MD Anderson Cancer Center in...

The results of a pair of long-term survival studies indicate the therapeutic value of BEXXAR (...

A new lab test that can improve survival rates among patients with chronic lymphocytic leukemia (...

Aggressive Non-Hodgkin’s Lymphomas (NHLs) are fast growing cancers (as opposed to indolent cancers). They involve...

A B cell is a type of lymphocyte that produces antibodies to fight infections. These are the most prevalent lymphocytes in the bloodstream and are...

Sitemap