Pfizer nabs another targeted cancer drug OK from FDA

Bosulif sales expected to reach $341M by 2016, analysts say

Pfizer ($PFE) has another targeted cancer drug approval under its belt. The FDA gave its blessing to Bosulif, a treatment for chronic myelogenous leukemia (CML) patients with Philadelphia chromosome-positive disease. It's a second-line approval, for patients who've failed on--or can't tolerate--another drug. Analysts figure the approval is worth $341 million in annual sales by 2016, Reuters reports.

The typical first-line therapy is Novartis' ($NVS) Gleevec, the first drug in the same class as Bosulif. The treatments work by inhibiting an enzyme called tyrosine kinase. Patients often become resistant to Gleevec, which is why second-line therapies such as Bosulif are increasingly important. Other second-line CML drugs include Bristol-Myers Squibb's ($BMY) Sprycel and Novartis' Tasigna.

"With the approval of tyrosine kinase inhibitors, we are seeing improvements in the treatment of CML based on a better understanding of the molecular basis of the disease," FDA's oncology chief Richard Pazdur said in a statement.

That "molecular basis" is cancer therapy's sweet spot these days, as drugmakers pin their hopes on specialized drugs for patients whose cancers exhibit specific characteristics.

Pfizer itself has now ushered 3 targeted cancer treatments through FDA over the past 15 months, beginning with the lung cancer drug Xalkori, approved last summer. Its kidney cancer drug Inlyta got the FDA's blessing in January, and just won European approval yesterday.

- read the FDA release
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- see the Reuters news
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