Full FDA Approval for Iclusig
November 28, 2016 – The U.S. FDA accelerates approval for Iclusig® (ponatinib) as it appears promising in mid-stage clinical trial data to treat patients who have serious conditions that are not controlled by existing therapies. The tyrosine kinase inhibitor (TKI), Iclusig, manufactured by Ariad Pharmaceuticals, Inc., was granted full approval for treating two rare types of leukemia, based on the results of continuing studies. Originally, Iclusig was granted accelerated approval on December. 14, 2012, after it showed effectiveness in phase II trials of patients in treating these two conditions.
Iclusig treats adults who have no other TKI therapy options for either chronic phase, blast phase or accelerated phase chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). It also is indicated for CML or Ph+ ALL that is T315I-positive, a specific kind of mutation that resists treatment with some other TKIs. Approximately one-third of clinical trial participants using Iclusig experienced some degree, including some fatal events, of artery blockages while taking the drug. Smaller numbers of participants developed venous thromboembolisms (blood clots in the veins), heart failure or liver damage. Iclusig’s label has a boxed warning about all of these potentially severe side effects. It is an oral drug with recommended initial dosing of 45mg once a day. However, doses frequently are lessened to 30mg or 15mg per day depending on the patient’s condition, response and side effects.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.