FDA approves leukemia drug from Roche

The Food and Drug Administration has approved a new drug from Roche to help treat patients with a type of cancer of the blood and bone marrow.

The agency cleared Gazyva to fight in combination with in who haven't previously been treated for the disease.

Gazyva works by killing cancer cells and encouraging the immune system to fight them.

The FDA approved the drug based on a study showing Gazyva plus chemotherapy was superior to chemotherapy alone at slowing the progress of the disease. Patients treated with Gazyva had median survival of 23 months before death, relapse or worsening of their disease. That compares with 11.1 months for the chemotherapy patients.

Gazyva will be marketed by Roche's Genentech unit, based in South San Francisco.

5 /5 (1 vote)
add to favorites email to friend print save as pdf

Related Stories

FDA approves genetic test for lung cancer drug

May 14, 2013

The Food and Drug Administration says it approved a genetic test from Roche to help doctors identify patients who can benefit from a lung cancer drug made by Genentech.

FDA: Roche drug works in early-stage breast cancer

Sep 10, 2013

The U.S. Food and Drug Administration has issued a positive review of a breast cancer drug from Roche that could soon become the first pharmaceutical option approved for treating early-stage disease before ...

New drug approved for lack of certain white blood cells

Aug 30, 2012

(HealthDay)—The U.S. Food and Drug Administration has approved the drug tbo-filgrastim to treat certain cancer patients undergoing chemotherapy who have a condition called severe neutropenia, the FDA said in a news release.

Recommended for you

XenOPAT, mouse models for personalized cancer treatment

28 minutes ago

On September 8th, the company XenOPAT SL, a spin-off of the Institute of Biomedical Research (IDIBELL) and the Catalan Institute of Oncology (ICO) was established with the aim of bringing the company the latest scientific ...

Gene linked to development of skin cancer in mice

3 hours ago

(Medical Xpress)—New research on an enzyme linked to cancer development shows that 37 percent of mice that produce excessive quantities of the enzyme developed skin tumors within four to 12 months of birth, ...

User comments