CHMP nod for Pfizer CML drug
pharmafile | January 21, 2013 | News story | Sales and Marketing | CHMP, CML, FDA, Pfizer
Pfizer’s cancer drug bosutinib has been given a positive opinion by the CHMP for patients with chronic myelogenous leukemia (CML).
The European recommendation follows the FDA’s decision in September to approve the drug, which is being marketed as Bosulif in the US.
The European Commission usually follows CHMP guidance, which means that bosutinib should soon be available to treat adults with chronic, accelerated and blast phase Philadelphia chromosome positive (Ph+) CML with resistance to, or intolerance of, prior therapy.
Patients may previously have been treated with one or more tyrosine kinase inhibitor (TKI), or Novartis’ Glivec (imatinib), Novartis’ Tasigna (nilotinib) and Bristol-Myers Squibb’s Sprycel (dasatinib) are not considered appropriate for them.
Pfizer says bosutinib is the only therapy approved with pivotal trial data, including CML patients treated with Glivec followed by a second generation TKI.
A Phase I/II study looked at 500 patients with Ph+ CML previously treated with one prior TKI (Glivec) or more than one TKI (Glivec plus Sprycel and/or Tasigna).
Major cytogenetic response (MCyR) at 24 weeks for patients previously treated with Glivec only was 33.8%, and 53.4% after a minimum follow-up of 23 months. The McyR for those on Glivec and at least one other TKI was 26.9% (32.4% after 13 months).
“We believe many doctors and CML patients will find this treatment, if approved, to be a welcome addition, offering a distinct adverse event profile and a convenient once-daily dosing regimen,” said Mace Rothenberg, senior vice president of clinical development and medical affairs at Pfizer’s oncology business unit.
In October, Teva’s CML injection Synribo (omacetaxine mepesuccinate) was also approved by the FDA for US use on the basis of likely future data showing it benefits patients.
Adam Hill
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