Ponatinib (Iclusig – Ariad), a tyrosine kinase inhibitor, has been approved by the FDA for treatment of chronic-, accelerated-, or blast-phase chronic myeloid leukemia (CML) or Philadelphia chromosome- positive (Ph+) acute lymphoblastic leukemia (ALL) resistant to prior tyrosine kinase inhibitor therapy. It is the fifth tyrosine kinase inhibitor approved for the treatment of CML or Ph+ ALL.

The October 2013 suspension of marketing and sales of ponatinib (Iclusig – Ariad) for treatment of leukemia1 has been lifted by the FDA, and the drug is expected to return to the market this month with narrower indications and heightened safety warnings.2 The reason for its suspension was a high incidence of thrombotic events, some of them fatal. The new indications limit use of the drug to patients with T315I-positive disease and those "for whom no other tyrosine kinase inhibitor is indicated," presumably because of resistance or intolerance.1. In brief: ponatinib (Iclusig) marketing and...

The FDA recently issued a Drug Safety Communication saying that it had asked the manufacturer of ponatinib (Iclusig – Ariad) to suspend marketing and sales of the drug because of the risk of life-threatening blood clots and severe narrowing of blood vessels.1 Ponatinib is a tyrosine kinase inhibitor that was granted accelerated approval by the FDA in December 2012 for treatment of chronic-, accelerated, or blast-phase chronic myeloid leukemia (CML) and Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) resistant to (or the patients were intolerant to) prior tyrosine...

The FDA has approved omacetaxine mepesuccinate (Synribo – Teva), a cephalotaxine known for many years as homoharringtonine, for treatment of adults with chronic or accelerated phase chronic myeloid leukemia (CML) who are no longer responding to, or who could not tolerate, two or more tyrosine kinase inhibitors.

Asciminib (Scemblix – Novartis), an oral kinase inhibitor, has been approved by the FDA for treatment of adults with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) previously treated with ≥2 tyrosine kinase inhibitors and for adults with Ph+ CML in CP with a T315I mutation.