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EMA safety panel rules no change needed for Ariad's Iclusig

Positive news comes after blood clot concerns

Ariad Iclusig ponatinib

The European Medicines Agency (EMA) has ruled the continued use of Ariad's cancer therapy Iclusig unchanged in the EU.

The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) brought an investigation into the safety of Iclusig (ponatinib) to a close late last week, concluding that there was no need to reduce the approved dose of the drug.

Iclusig was approved in the US and EU last year for the treatment of adult patients with chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), but quickly ran into problems after it was linked to an increased risk of blood clots.

The safety concerns culminated in the drug being temporarily withdrawn from the market in the US and placed under a clinical hold - suspending all clinical trials of the drug - which prompted Ariad to slash its workforce. Around the same time, the EMA announced it was also reviewing the safety of the drug but would allow it to remain on the market in the meantime.

The FDA allowed Iclusig back on the market in January, subject to certain restrictions and a comprehensive Risk Evaluation and Mitigation Strategy (REMS), while the EMA concluded last November it could stay on the market provided it was not prescribed to patients with a history of heart attack or stroke.

The PRAC ruled ahead of the weekend that Iclusig's benefits outweigh its risks but its labelling should be updated to include a requirement for patient monitoring, dose reduction if patients respond to the drug and the possibility of discontinuing the drug within three months if there is no response to treatment.

Ariad's chief executive Harvey Berger commented: "The PRAC recommendation provides insightful guidance to healthcare professionals and patients regarding the use of Iclusig … and importantly, leaves the original Iclusig indication statement unchanged.”

The company is keen to put the safety issues with Iclusig behind it and concentrate on growing the product, which is showing some signs of acceleration with US sales of $8m in the second quarter, a 70% increase on the first three months of the year, along with a $6m contribution from Europe - mainly from France which was one of the few countries to have agreed reimbursement before the EMA safety review came into effect.

The company is also conducting a trial of a lower dose of Iclusig to see if it can maintain efficacy whilst reducing the cardiovascular risks, and is supporting a number of independent studies in other indications, including stomach cancer, non-small cell lung cancer (NSCLC), medullary thyroid cancer, endometrial cancer and acute myeloid leukaemia (AML).

Ariad has two other product candidates in development, AP26113 for advanced solid tumours including NSCLC (in a phase I/II trial) and ridaforolimus for cardiovascular indications, which is in early-stage testing.

Article by
Phil Taylor

13th October 2014

From: Research, Regulatory



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