Ariad files new blood cancer drug with the FDA
pharmafile | July 31, 2012 | News story | Research and Development, Sales and Marketing | Ariad, CML, EMA, FDA, Glivec, blood cancer
Ariad has filed its investigational blood cancer drug ponatinib with the FDA and hopes for an accelerated review.
The US biotech is seeking FDA marketing approval of ponatinib in patients with resistant or intolerant chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL).
The company has asked for an accelerated approval by the FDA, which, if granted, would mean that the drug could be on the market within six months.
Ariad said it anticipates the US approval and commercial launch of ponatinib, a pan-BCR-ABL inhibitor, in the first quarter of next year.
The firm said it also plans to submit a marketing application to the EMA by the third quarter, which could also the drug approved in Europe by 2013.
But if it is approved it would be up against a competitive market. This market is dominated by tyrosine kinase inhibitors such as Novartis’ Glivec (imatinib), Novartis’ Tasigna (nilotinib) and Bristol-Myers Squibb’s Sprycel (dasatinib).
Glivec is the biggest selling of these drugs, and brought in $1.51 billion in sales last year, although it does also have a licence to treat certain stomach tumours.
But Ariad is confident ponatinib’s mode of action is different from these brands as it bypasses T315I, the so-called ‘gatekeeper’ mutation in CML and can potentially treat patients with all mutations.
Analysts EvaluatePharma said that the drug demonstrated ‘very strong data’ at the ASCO cancer conference this year and if it can gain a frontline setting – which it has just begun new Phase III trials in – this would open up a ‘major blockbuster opportunity’ for the drug.
EP said that this would be ‘no mean feat’ for a business whose only other late-stage project, Taltorvic (ridaforolimus), was rejected by the FDA last month.
The Agency said it wants further clinical trials from the firm to further assess its safety and efficacy as a maintenance therapy for metastatic soft tissue or bone sarcoma.
Ben Adams
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