Showing posts with label Richard Padzur. Show all posts
Showing posts with label Richard Padzur. Show all posts

Saturday, December 15, 2012

Ponatinib in CML


FDA Approves Ponatinib for Rare Leukemias

Zosia Chustecka
Disclosures Dec 14, 2012
Ponatinib ( Iclusig, Araid) was approved today by the US Food and Drug Administration (FDA) for use in patients with 2 leukemias that have stopped responding to other therapies, and offers new hope for these subgroups of patients. The approval comes 2 months earlier than expected.
Ponatinib is approved for use in patients with chronic myeloid leukemia (CML) and also Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukemia (Ph+ ALL) who have relapsed or are refractory to other therapies. Many of these patients, but not all, have developed a T3151 mutation, which makes the disease resistant to the standard treatment with tyrosine kinase inhibitors (TKIs) such as imatinib ( Gleevec).
"The approval of ponatinib is important because it provides a treatment option to patients with CML who are not responding to other drugs, particularly those with the T3151 mutation who have few therapeutic options," said Richard Pazdur, MD,