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news.The FDA has accepted Pfizer’s new drug application (NDA) for standard review of bosutinib for patients with previously treated Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML).
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Bosutinib is an oral, once-daily, investigational dual Src and Abl kinase inhibitor with minimal inhibitory activity against c-kit and PDGFR.
By dual inhibition of the Src and Abl tyrosine kinases, bosutinib may inhibit signaling in CML cells that allows the cells to grow, survive and reproduce, the company said.
This submission was based on efficacy and safety data from Study 200, a single-arm study of bosutinib in over 500 patients with previously treated Ph+ CML.
Pfizer oncology business unit president and general manager Garry Nicholson said the filing underscores their commitment to bring treatment options to hematologic patient populations like CML.