EMA keeps Ariad cancer drug on the market
pharmafile | October 13, 2014 | News story | Sales and Marketing | Ariad, CML, EMA, PRAC, iclusig, leukaemia, ponatinib
The EMA has recommended Ariad’s leukaemia drug Iclusig (ponatinib) should continue to be used under its current indication despite ongoing safety worries.
Concerns were first raised last year that the drug could lead to an increased risk of blood clots or blockages in the arteries. The FDA has suspended sales in the US and terminated a Phase III trial, but the drug has remained on sale in Europe for patients with no history or risk of cardiovascular problems.
The Pharmacovigilance Risk Assessment Committee (PRAC) assessed the available data on the nature, frequency and severity of blood clots or vessel blockage and concluded that Iclusig’s benefits continue to outweigh its risks. The committee recommended, however, that product information for patients and healthcare professionals should be updated with strengthened warnings.
Although the risk of blood clots and vessel blockages is likely to be dose-related, the PRAC says that there are insufficient data to formally recommended the use of lower doses of the drug, and there is a risk that lower doses might not be as effective in all patients and in long-term treatment.
Iclusig will therefore continue to have a recommended starting dose of 45mg a day. The new updates to product information, however, will provide healthcare professionals with the latest evidence in case they want to consider reducing the dose in patients with chronic-phase chronic myeloid leukaemia (CML) who are responding well to treatment and might be at particular risk of blood vessel blockage.
The PRAC has also recommended that healthcare professionals should stop Iclusig if there has been no response after three months of treatment, and monitor patients for high blood pressure or signs of heart problems.
Iclusig is used to treat CML and acute lymphoblastic leukaemia (ALL) in patients who do not respond to standard treatments, and works by blocking an enzyme involved in stimulating cancer cells to divide uncontrollably.
The PRAC recommendation will be forwarded to the Committee for Medicinal Products for Human Use (CHMP), which will adopt the EMA’s final opinion. Ariad’s chairman and chief executive officer Harvey Berger, says: “We are grateful for the rigorous and in-depth review provided by the PRAC.
“The PRAC recommendation provides insightful guidance to healthcare professionals and patients regarding the use of Iclusig in patients with Ph+ leukemias and importantly, leaves the original Iclusig indication statement unchanged.
“We look forward to consideration and adoption of these recommendations by the CHMP later this month and authorization by the European Commission by the end of the year.”
Analysts originally predicted that the drug could generate sales of up to $821 million by 2018.
A new study is also planned to help clarify if lower doses of Iclusig reduce its risks while still having a beneficial effect in patients with chronic phase CML.
George Underwood
Related Content
Rethinking oncology trial endpoints with generalised pairwise comparisons
For decades, oncology trials have been anchored to a familiar set of endpoints. Overall survival …
ViroCell and UCL launch trial to treat childhood leukaemia relapse
ViroCell Biologics has manufactured a GMP-grade lentiviral vector for a University College London (UCL) clinical …
NICE issues positive final guidance for treatment of Duchenne Muscular Dystrophy from Santhera
Santhera Pharmaceuticals has received positive final guidance from the National Institute for Care and Excellence …
