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EMA approves marketing authorisation for ponatinib/Iclusig

On 21 March 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Iclusig 15 mg and 45 mg film-coated tablets intended for the treatment of chronic myeloid leukaemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL). Iclusig was designated as an orphan medicinal product on 2 March 2010. The applicant for this medicinal product is ARIAD Pharma Ltd. They may request a re-examination of any CHMP opinion, provided they notify the European Medicines Agency in writing of their intention within 15 days of receipt of the opinion.

The active substance of Iclusig is ponatinib, a protein kinase inhibitor (L01XE24). It acts by inhibiting the BCR‑ABL kinase.

The benefits with Iclusig are its cytogenetic and haematological response rates in patients with CML and Ph+ ALL including patients bearing T315I mutation. The most common side effects are platelet count decreased, rash, dry skin, and abdominal pain.

A pharmacovigilance plan for Iclusig will be implemented as part of the marketing authorisation.

The approved indication is: “Iclusig is indicated in adult patients with:
chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation
Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.
It is proposed that Iclusig be initiated by physicians experienced in the diagnosis and treatment of patients with leukaemia.

http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_...

So only another few years until NICE recognises its utility, well behind the curve of others.

Cynical Saturday

C

Hi Chris,

Well yes you may be right. Usually, as soon as EMA give approval for marketing authorisation then NICE likes to come in as soon as it possibly can. We are expecting ponatinib will enter the HTA process before the end of this year.
Ariad has indicated that "We anticipate receiving marketing authorization by the European Commission later this summer". It is though I agree a long (and for us) and tortuous process. Hope the snow is not too deep?

Best, Sandy

Hi Sandy,

No snow in Bristol, just a bit of rain. We seem to have escaped - my parents in Halifax though have 18" plus drifting.

At least if Iclusig is approved in Europe it should make any application using the cancer drugs fund a bit more straightforward, right?

Chris

Yes Chris you are correct. The granting of EMA marketing authorisation for iclusig will be of assistance for clinicians making applications to the Fund on behalf of their patients provided of course their patients meet the 'indication' description in the CHMP opinion and assuming Ariad do not request any re-examinaion.

Assuming Ariad are content then the NICE machinery will step up a gear because they do not favour a lengthy gap between marketing authorisation being granted and entry into their appraisal system. Another assumption operative is a Ministerial recommendation for entry into the NICE appraisal system, it is unlikely that a Minister would refuse this.

David

It is worth stressing that a clinician can make an application for ponatinib for treatment of a patient outside the indication description. However approval would be less likely.

The big change after 1st April this year is that the NHS Commissioning Board will manage the Fund on a national basis whereas it is currently managed on a regional basis which has produced inconsistencies in approvals.