Ariad cancer drug pulled amid safety fears
pharmafile | November 1, 2013 | News story | Sales and Marketing | Ariad, FDA, iclusig, leukaemia
Ariad Pharmaceuticals has been forced by the FDA to suspend sales of its blood cancer drug Iclusig given the high risk of blood clots from the medicine.
The drug was given an accelerated approval at the end of last year and has licences to treat two rare blood cancers: a type of chronic myeloid leukaemia (CML) and a version of acute lymphoblastic leukaemia.
“At this time, FDA cannot identify a dose level or exposure duration that is safe,” the agency said in a statement.
The US regulator has also recommended patients currently taking Iclusig and not responding to it to immediately stop treatment and explore alternative options.
Patients responding to Iclusig should be treated under a drug development setting as long as the FDA was investigating the safety issues, it added.
The FDA passed the drug under an accelerated approval, which is granted based on promising data from early trials but the process still requires further studies to prove the drug is as effective as initially thought.
If the drug is not as effective or deemed unsafe in follow-up studies, the regulator can pull or suspend the treatment, as the FDA has done here.
In fact this type of speed review from the FDA came under pressure just this week, after research published in the BMJ showed that these types of approvals can put patients at risk as fewer trials are undertaken in the run up to a marketing application.
This also comes less than a month after the firm stopped an ongoing trial of the drug which was down to the same safety concerns.
Ariad mutually agreed with the FDA in October that its Phase III EPIC trial should be terminated because patients treated with Iclusig suffered arterial thrombotic events.
The study was suspended before being scrapped completely and the 300 or so patients from EPIC are now being removed from treatment.
Future sales
The company had been bullish about the drug’s prospects at the beginning of the year, confident that its mode of action is different from existing brands in the field – tyrosine kinase inhibitors such as Novartis’ Glivec, Novartis’ Tasigna and Bristol-Myers Squibb’s Sprycel.
It works by bypassing T315I, the so-called ‘gatekeeper’ mutation in CML which has been associated with resistance to other approved treatments. The treatment was expected to generate sales of about $821 million by 2018, according to analysts.
Ariad reported net sales of $13.9 million for the drug for the quarter ending in June, but this suspension will damage the firm’s prospects for the drug, leaving its future in doubt.
Ben Adams
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