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FDA grants priority review to Bosulif for first-line treatment of chronic myeloid leukemia subtype
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The FDA granted priority review to bosutinib for the treatment of patients with newly diagnosed, chronic phase Philadelphia chromosome-positive chronic myeloid leukemia, according to the drug’s manufacturer.
Bosutinib (Bosulif, Pfizer), an oral tyrosine kinase inhibitor, already is approved at a dose of 500 mg once daily for adults with Ph+CML who were resistant to or intolerant of prior therapy.
Pfizer submitted a supplemental new drug application that seeks to expand bosutinib into a first-line treatment at a dose of 400 mg.
The supplemental application included results from the multicenter, open-label phase 3 BFORE trial, designed to compare the efficacy and safety of bosutinib with imatinib.
Patients treated with bosutinib demonstrated superior molecular response rates at 12 months. Bosutinib’s safety profile appeared consistent with prior studies.
“As physicians gained experience with Bosulif, they have come to appreciate its favorable risk-benefit profile in patients with [Philadelphia chromosome-positive] CML who no longer responded to or could not tolerate prior TKI therapy,” Mace Rothenberg, MD, chief development officer of oncology at Pfizer Global Product Development, said in a company-issued press release. “At the 400-mg dose, we believe that the BFORE study demonstrates a similarly favorable risk-benefit in previously untreated patients with [Philadelphia chromosome-positive] CML. We look forward to working with the FDA in our efforts to expand the label for Bosulif to include this important group of patients.”
The FDA is expected to make its decision by December.