Pfizer’s Bosulif scores US green light in leukaemia sub-type
Pfizer has revealed that its tyrosine kinase inhibitor Bosulif (bosutinib) has been awarded marketing authorisation from the FDA in the treatment of newly-diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML) in adult patients.
The decision was based on Phase 3 data which showed that use of Bosulif was linked to a significantly higher rate of major molecular response of 47.2% at 12 months, compared to 36.9% in those treated with current standard of care imatinib (Novartis’ Glivec). Additionally, complete cytogenic response rate stood at 77.2% with Bosulif compared to 66.4% with imatinib.
An ongoing long-term follow up trial in in progress, and continued approval may be dependent on whether it can confirm clinical benefit of the drug.
“Bosulif was Pfizer’s first treatment for hematologic malignancies, and has since become an important treatment option for Ph+ CML patients who are resistant or intolerant to previous therapy,” commented Liz Barrett, Global President of Pfizer Oncology. “This expanded indication has the potential to make an even greater impact on the lives of patients with CML. Today’s news marks the third FDA approval for a Pfizer haematology medicine in just five months, a significant achievement that reinforces our commitment to patients living with blood cancers.”
Bosulif already secured approval for the treatment of chronic, accelerated or blast phase Ph+ CML with resistance or intolerance to prior therapy back in 2012.
“Among patients with CML today, with the various treatment options available, it is important to recognize the unique needs of each of my CML patients and prescribe treatments that best meet those needs,” added Jorge E Cortes from The University of Texas MD Anderson Cancer Center. “The efficacy and distinct tolerability profile of Bosulif make it an important and useful treatment option for newly diagnosed CML patients.”
The US Food and Drug Administration (FDA) has granted de novo marketing authorisation to the …
Biogen has announced that the US Food and Drug Administration (FDA) has approved Tofidence (tocilizumab-bavi) …