Pharmaceutical giant Pfizer has announced that the US Food & Drug Administration has accepted the company's NDA (new drug application) for standard review of bosutinib, an oral, once-daily drug treatment for adult patients with previously treated Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML).
This amounts to a potentially second- or third- line therapy for patients whose disease proves resistant to imatinib (Gleevec) and patients who received dasatinib or nilotinib.
Currently these treatments represent first- and second- line therapies for CML, a disease that accounts for about 15 percent of leukemia diagnoses worldwide.
Acceptance of the NDA comes on the heels of the safety and efficacy data from Study 200, a single-arm trial of bosutinib in Ph+ CML patients with at leastone prior treatment.
Source: Therapeutics Daily
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