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Leukemia Drug Approved by the FDA

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[ Science]

Pfizer this week announced that Bosulif, a medication it developed for the treatment of a rare type of Leukemia, has been approved by the U.S. Food and Drug Administration.

The medication is approved for the treatment of adults with chronic, accelerated, or blast phase Philadelphia chromosome-positive chronic myelogenous leukemia (CML) that has resisted prior therapy. The American Cancer Society estimates that almost 5,500 new CML cases will be diagnosed in 2012, and that just over 600 people will die of the disease. Just over 10% of new leukemia cases are CML, and over half of the people who get it are over the age of 65. According to Pfizer, Bosulif blocks CML cell growth by inhibiting the Abl and Src signaling pathways.

“Bosulif is an important new addition to the CML treatment landscape,” said Dr. Jorge Cortes, professor of medicine in the Department of Leukemia at the University of Texas, and a lead investigator of the Pfizer’s registrational study for Bosulif. “Despite recent advances, an unmet need remains for many CML patients who are refractory to one or more tyrosine kinase inhibitors.”

Bosulif was quickly approved because of its status as an orphan drug. Orphan drugs are drugs that have been developed to treat rare diseases and conditions. In the U.S. and E.U., orphan drugs are fast-tracked for approval, and companies can often charge a premium for them. The wildly expensive scorpion antivenom Anascorp is another example of a recently approved orphan drug.

Leukemia Drug Approved by the FDA
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  • Beth DM

    I appauld whenever a new leukemia drug is approved! That means one more chance someone can live longer! I have first hand knowledge on how this is a victory. My father passed away from AML. I was waiting for feverfew in liquid form to be approved by the FDA. The feverfew from a flower called Chrysanthemum parthenium has been currently used for headache victims. Studies in the US at a university have shown that a liquid form of feverfew has been successful in ripping out the roots of the leukemic cells! I was awaiting for my father to be able to try this liguid form. However, when I contacted the research team at the university they said the US did not want to pursue the feverfew and they had to take the study to England. I beg Obama to bring the study back here so others may be able to try this homeopathic study. My father passed away and was never given another chance….so this new approval on the CML RX is another possible life that will be saved! Great job Pfizer!:)

  • http://yahoo marianne reeves

    Great news for people with CML! Recently by oldest brother (52) passed away 7/31/12 due to AML. I hope & pray one day there will be a cure for AML as well. Thank you to all who had a part in this medication may we continue to keep finding cures for these diseases.

  • http://CML2 Lotie

    Being a patient and living with CML for 16 years, I find this news very comforting. I have been on nearly every drug produced to treat CML and find myself resisting them all. I look forward to finding any new research that would lead to a cure or bring everyone to a molecular remission. That would be a good insurance policy.

  • http://GOOGLE PAT HAWKINS

    I DONT HAVE HIGH BLOOD PRESSURE.BUT IN THE LAST MONTH YAHOO PRINTED SEVERAL ARTICLES ON THESE HIGH BLOOD PRESSURE LOWERING DRUGS.THEY SAID THE SIDE EFFECTS ARE TERRIBLE AND MOST PATIENTS HAVE TO BE PRESCRIBED ANOTHER ONE OR TWO MEDICINES TO COUNTER ATTACK THE SIDE EFFECTS OF THESE DRUGS!IF I EVER GET HIGH BLOOD PRESSURE ILL FOLLOW MY DIET TO A T WHICH MOST HIGH BLOOD PATIENTS WILL NOT DO!THEY STILL EAT RED MEAT,USE SALT,EAT HARDLY NO GREEN VEGETABLES AND DRINK PEPSI OR ICED TEA WHICH ARE VERY BAD FOR YOUR HEART AND ARTERIES!MOST DONT TAKE ADEQUATE VITAMINS AND MINERALS THAT CLEAN OUT BAD PROPERTIES IN THEYRE SYSTEMS.MOST EAT MASHED POTATOES WITH GRAVY,RICE AND GRAVY,RED MEAT,ICE CREAM AND ALL KINDS OF DESSERTS!THEY JUST CANT SAY NO TO WHAT THEY ARE USED TO EATING ALL OF THEYRE LIVES!