Ponatinib launched for chronic myeloid and acute lymphoblastic leukaemias
Patients with certain types of leukaemia now have the option of being treated with ponatinib.
The new medicine is indicated for adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia who are resistant to dasatinib or nilotinib; who are intolerant of dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; as well as those who have the T3151 mutation. It is also indicated for the treatment of patients with Philadelphia chromosome-positive acute lymphoblastic leukaemia who are resistant to dasatanib; who are intolerant of dasatanib and for whom subsequent treatment with imatinib is not appropriate; or who have the T3151 mutation.
The medicine received a positive recommendation from the European Medicines Agency in March 2013. However, ponatinib’s manufacturer Ariad Pharma told PJ Online that the EMA is currently reviewing safety data regarding a potential increased risk of blood clots associated with the medicine.
Ponatinib is a tyrosine kinase inhibitor with activity against the BCR-ABL protein. The most common side effects are decreased platelet count, rash, dry skin and abdominal pain.
Ponatinib is marketed as Iclusig by Ariad.
Action: Tyrosine kinase inhibitor of the BCR-ABL protein
Dose: Recommended starting dose is 45mg once daily until disease progression or unacceptable toxicity. To manage toxicity the dose can be adjusted to 15mg or 30mg once daily.
Legal category: POM
Price: 60 x 15mg tablets, or 30 x 45mg tablets, £5,050
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2013.11129916