FDA approves new leukemia drug from Roche - KALB-TV News Channel 5 & CBS 2

FDA approves new leukemia drug from Roche

Posted: Updated:
Photo Credit: MGNOnline.com Photo Credit: MGNOnline.com

WASHINGTON (AP) - The Food and Drug Administration on Friday 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 chronic lymphocytic leukemia in combination with chemotherapy in patients who haven't previously been treated for the disease.

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

Chronic lymphocytic leukemia develops slowly over time and is usually diagnosed in the elderly. More than 15,600 Americans will be diagnosed and 4,580 of them will die from the disease this year, according to estimates from the National Cancer Institute.

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.

The injectable biotech drug is the first medicine approved under FDA's breakthrough designation, which was authorized by Congress last year. The new designation is designed to speed up the approval of promising drugs by providing companies with extra meetings and earlier communication with FDA scientists to discuss drug development.

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

A spokeswoman for Genentech said the drug would cost $41,300 for one course of treatment, which lasts six months.

Common side effects seen in company studies included anemia, fever, muscle and bone pain and lower levels of white blood cells.

Copyright 2013 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

  • Most Popular StoriesMost Popular StoriesMore>>

  • *UPDATE* Missing juvenile female in Alexandria FOUND

    *UPDATE* Missing juvenile female in Alexandria FOUND

    Thursday, April 24 2014 6:31 PM EDT2014-04-24 22:31:25 GMT
    ALEXANDRIA, La. (KALB News Channel 5) - The Rapides Parish Sheriff’s Office is asking for the public’s assistance in locating a missing juvenile. Gabrielle Dubroc is described as a white female, 14 years of age, with brown hair, brown eyes, and is 5’2” tall.More >>
    ALEXANDRIA, La. (KALB News Channel 5) - The Rapides Parish Sheriff’s Office is asking for the public’s assistance in locating a missing juvenile. Gabrielle Dubroc is described as a white female, 14 years of age, with brown hair, brown eyes, and is 5’2” tall.More >>
  • New "Swatting" game causes massive police response

    New "Swatting" game causes massive police response

    Thursday, April 24 2014 12:57 PM EDT2014-04-24 16:57:42 GMT
    LONG BEACH, N.Y. (CBS News) - Police descended upon a home in Long Island, N.Y. Tuesday after receiving a 911 call from a man who said he had shot several of his relatives inside the house.More >>
    LONG BEACH, N.Y. (CBS News) - Police descended upon a home in Long Island, N.Y. Tuesday after receiving a 911 call from a man who said he had shot several of his relatives inside the house.More >>
  • Woman allegedly attacked boyfriend with ax, went after neighbors

    Woman allegedly attacked boyfriend with ax, went after neighbors

    Thursday, April 24 2014 12:50 PM EDT2014-04-24 16:50:25 GMT
    LUNENBURG, Mass. (CBS News) - A Massachusetts woman has been arrested after she allegedly attacked her boyfriend with an ax before also going after the couple across the street, reports CBS Boston.More >>
    LUNENBURG, Mass. (CBS News) - A Massachusetts woman has been arrested after she allegedly attacked her boyfriend with an ax before also going after the couple across the street, reports CBS Boston.More >>
Powered by WorldNow
Powered by WorldNow
All content © Copyright 2000 - 2014 WorldNow and KALB. All Rights Reserved.
For more information on this site, please read our Privacy Policy and Terms of Service.