Pfizer’s Bosulif accepted for new regulatory review in US and EU

Pfizer has announced that its cancer drug Bosulif has been accepted for review by regulatory bodies in the US and EU.

A supplemental new drug application for the chronic myeloid leukaemia (CML) therapy has been accepted and granted priority review by the US Food and Drug Administration, while the European Medicines Agency has also validated a type II variation application for review.

Both bodies will assess whether the drug's indication should be expanded to include patients with newly-diagnosed chronic phase Philadelphia chromosome-positive (Ph-positive) CML, based on positive results from a phase III trial.

In the BFORE study, it was demonstrated that Bosulif was associated with a significantly higher rate of patients achieving major molecular response at 12 months compared with an established alternative.

Dr Mace Rothenberg, chief development officer for oncology at Pfizer's global product development division, said: "As physicians gained experience with Bosulif, they have come to appreciate its favourable risk-benefit profile in patients with Ph-positive CML who no longer responded to or could not tolerate prior TKI therapy."

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