Could cut months off approval decision for ponatinib
Ariad Pharmaceuticals' blood cancer drug ponatinib has won a rapid assessment from European regulators, potentially cutting months off its approval timeline.
The European Medicines Agency's (EMA) accelerated assessment is only granted to drugs in areas of high unmet medical need or that are expected to have major impact on medical practice.
Ariad is seeking approval for ponatinib's use to treat adults with chronic myeloid leukaemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to, or intolerant of, prior treatment – an indication for which there are few available treatment options.
“The accelerated assessment granted to our marketing authorisation application further illustrates the major unmet medical need among patients with CML and Ph+ ALL who have become resistant or intolerant to prior tyrosine kinase inhibitor therapy,” said Dr Harvey Berger, chair and CEO of Ariad.
"As we establish our European headquarters in Lausanne, Switzerland and develop our commercial infrastructure in the region, our regulatory team will continue to work closely with the EMA," he added.
The application is based on results in the ongoing PACE trial involving patients with chronic CML who had shown resistance to or intolerance of prior tyrosine kinase inhibitor therapy.
The trial demonstrated that after ponatinib treatment 54 per cent of chronic CML patients achieved the primary endpoint of major cytogenetic response, which means more than 65 per cent of a person's cells are normal.
Ariad's CEO Berger told Bloomberg the drug could achieve global annual sales of $800m if its current application in CML and Ph+ ALL in approved, but that this could rise to $1.5bn if the drug can secure a licence to treat patients with newly diagnosed CML. Such an authorisation, for which trials are on-going, would see ponatinib compete head-on with Novartis' Glivec (imatinib).