Pfizer Wins FDA Approval for Chronic Leukemia Drug

by Christopher Freeburn | September 5, 2012 11:24 am

Pfizer (NYSE:PFE[1]) announced on Tuesday that it has received Food and Drug Administration (FDA) clearance[2] for Bosulif, an anti-leukemia treatment.

The drug has been approved for use in adults with chronic myeloid leukemia that has already been treated and also possess the so-called Philadelphia chromosome, a genetic abnormality, Bloomberg noted.

Drugs from Novartis (NYSE:NVS[3]) and Bristol-Myers Squibb (NYSE:BMY[4]) have already been approved to treat patients suffering from this kind of leukemia, generating annual sales of $716 million and $803 million, respectively.

Another drug designed to treat chronic myeloid leukemia from Ariad Pharmaceuticals (NASDAQ:ARIA[5]) is awaiting FDA clearance, which could come early next year.

The condition is expected to produce 5,400 new cases and cause more than 600 deaths this year, according to medical groups. Due to the relatively low number of people affected by chronic myeloid leukemia, Bosulif is considered an “orphan drug.” That designation is applied to drugs designed to combat conditions affecting less than 200,000 people.

Including Bosulif, Pfizer has been granted FDA approval for three anti-cancer drugs in the past thirteen months.

Pfizer shares were mostly flat in Wednesday morning trading.

  1. PFE:
  2. that it has received Food and Drug Administration (FDA) clearance:
  3. NVS:
  4. BMY:
  5. ARIA:

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