FDA Approvals of 2012

23 of 39


Drug: Bosulif
Generic molecule: bosutinib
Company: Pfizer
Approval date: Sept. 4

The scoop: Bosutinib is an orphan drug for treatment of chronic myelogenous leukemia. The FDA estimates that 5,430 Americans will be diagnosed with CML this year. Bosulif, a kinase inhibitor, became the third new cancer drug from Pfizer Oncology's pipeline to be approved by the FDA in a 13-month period. On the eve of approval, a spokesperson for Pfizer told FierceBiotech that the drug would cost less than $8,200 a month.