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FDA suspends sale of Ariad’s cancer drug

Iclusig linked to increased risk of blood clots
Ariad Iclusig ponatinib

The US Food and Drug Administration (FDA) has asked Ariad to suspend sales of its leukaemia drug Iclusig as it continues to investigate reports of life-threatening side effects.

The suspension follows a warning about the risk of blood clots and severe narrowing of blood vessels that was issued by the FDA on October 11.

Ariad was also forced to stop the EPIC trial of the drug in patients with newly-diagnosed chronic myeloid leukaemia (CML) last week and said in a statement it was stopping distribution "while it continues to negotiate updates to the US prescribing information for Iclusig and implementation of a risk mitigation strategy."

The FDA said that "patients currently receiving Iclusig should discuss with their healthcare professionals the risks and benefits of continuing treatment with the drug”, although it recommended that patients who are not responding to the drug have their treatment stopped immediately. 

Shares in Ariad went into free-fall after investors reacted to news of the suspension, with the stock closing down 44 per cent to $2.20 yesterday, having been as high as $24 in the last 12 months.

Iclusig is Ariad's only marketed product having been granted accelerated approval by the FDA just under a year ago as a second-line treatment for adults diagnosed with chronic phase, accelerated phase, or blast phase CML or Philadelphia chromosome-positive acute lymphoblastic leukaemia (ALL).

The drug is also available in Europe, but at the time of writing the European Medicines Agency (EMA) had not indicated whether it would follow the FDA's lead and suspend sales.

Around 24 per cent of patients in a phase II clinical trial and 48 per cent of patients in a phase 1 clinical trial have experienced serious adverse vascular events, said the FDA.

The reactions included "fatal and life-threatening heart attack, stroke, loss of blood flow to the extremities resulting in tissue death, and severe narrowing of blood vessels in the extremities, heart, and brain," it said in a statement.

Iclusig brought in sales of around $20m in the first half of this year, but on launch had been predicted to reach $1bn or more in turnover at peak depending on approvals in follow-up indications, such as non-small cell lung cancer (NSCLC), medullary thyroid cancer and gastrointestinal stromal tumours (GIST).

Article by
Phil Taylor

1st November 2013

From: Sales, Regulatory

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