Ariad Pharmaceuticals is celebrating after getting the green light from regulators in Europe for its leukaemia drug Iclusig.
Specifically, the European Commission has granted a marketing authorisation for Iclusig (ponatinib) for two indications. First up, it has been approved to treat adults with chronic, accelerated or blast phase chronic myeloid leukaemia who cannot tolerate Novartis' Tasigna (nilotinib) or Bristol-Myers Squibb's Sprycel (dasatinib) and for whom subsequent treatment with Novartis' Glivec (imatinib) is not appropriate or who have the T315I mutation.
The EC has also given the thumbs-up to Iclusig for the treatment of adults with Philadelphia-chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to Sprycel, should not take Glivec and who have the T315I mutation.
Ariad was granted accelerated assessment by the European Medicines Agency's Committee for Medicinal Products for Human Use and chief executive Harvey Berger said "we are delighted by the rapid approval…and will now work closely with the national health authorities to make Iclusig available to Ph+ leukaemia patients as quickly as possible".
The company quoted Stephen O'Brien at Newcastle University, UK, as saying that "we have seen deep, durable responses from this once daily, oral treatment, and it would appear that Iclusig is a very useful new medicine for CML and Ph+ ALL patients who have become resistant to, or intolerant of, other tyrosine kinase inhibitors". The drug was approved in the USA at the end of 2012.