FDA approves new leukemia drug from Roche - 21 News Now, More Local News for Youngstown, Ohio -

FDA approves new leukemia drug from Roche

Posted: Updated:

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 This material may not be published, broadcast, rewritten or redistributed.

  • More From wfmj.comMore>>

  • Ocean crash kills teen pilot seeking world record

    Ocean crash kills teen pilot seeking world record

    Wednesday, July 23 2014 10:03 PM EDT2014-07-24 02:03:01 GMT
    A family spokeswoman says an Indiana teenager was killed when his plane crashed while trying to set a record for an around-the-world flight.More >>
    His pilot's license fresh in his hands, an Indiana teenager set out in June for the adventure of a lifetime: an around-the-world flight with his father designed to break a record and raise money to build schools in his...More >>
  • Ohio veteran cited for ducks hopes for law change

    Ohio veteran cited for ducks hopes for law change

    Wednesday, July 23 2014 9:56 PM EDT2014-07-24 01:56:55 GMT
    COSHOCTON, Ohio (AP) - An Army veteran who says his pet ducks help relieve his post-traumatic stress disorder is now hoping for a change in the Ohio village law that prohibits him from keeping the animals in his backyard. Darin Welker, who served in the Army National Guard, was cited for violating a ban on keeping farm animals in West Lafayette. The village is about 80 miles east of Columbus. Welker and his attorney said Wednesday that village officials are considering the possibility of a n...More >>
    COSHOCTON, Ohio (AP) - An Army veteran who says his pet ducks help relieve his post-traumatic stress disorder is now hoping for a change in the Ohio village law that prohibits him from keeping the animals in his backyard. Darin Welker, who served in the Army National Guard, was cited for violating a ban on keeping farm animals in West Lafayette. The village is about 80 miles east of Columbus. Welker and his attorney said Wednesday that village officials are considering the possibility of a n...More >>
  • More than 500 migrant children sent to Pa.

    More than 500 migrant children sent to Pa.

    Wednesday, July 23 2014 9:31 PM EDT2014-07-24 01:31:15 GMT
    HARRISBURG, Pa. (AP) - More than 500 migrant children are being housed in Pennsylvania as federal officials wrestle with a national crisis created by a flood of tens of thousands of unaccompanied minors across the southern U.S. border. State officials confirmed Wednesday that the federal government told them 120 children are in two temporary centers in Bethlehem and Womelsdorf, near Reading. Kait Gillis of the state Department of Public Welfare says the other 386 youngsters are staying with ...More >>
    HARRISBURG, Pa. (AP) - More than 500 migrant children are being housed in Pennsylvania as federal officials wrestle with a national crisis created by a flood of tens of thousands of unaccompanied minors across the southern U.S. border. State officials confirmed Wednesday that the federal government told them 120 children are in two temporary centers in Bethlehem and Womelsdorf, near Reading. Kait Gillis of the state Department of Public Welfare says the other 386 youngsters are staying with ...More >>
Powered by WorldNow
All content © Copyright 2000 - 2014 Worldnow and WFMJ. All Rights Reserved. For more information on this site, please read our Privacy Policy and Terms