Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Approves Iclusig for Certain Types of CML, ALL

Ariad news release; 2016 Nov 29

The FDA has approved Iclusig (ponatinib) to treat certain types of chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).

Indications: Iclusig is a kinase inhibitor indicated for the treatment of adult patients with chronic phase, accelerated phase, or blast phase CML, or Ph+ ALL for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated.

Dosage and administration: 45 mg taken orally once daily. For hepatic impairment, 30 mg orally once daily.

Efficacy and safety: Approval is based on data from the PACE trial, which showed that 55% of chronic phase CML patients achieved major cytogenetic response.

Side effects/risks: Most common adverse reactions are abdominal pain, rash, constipation, headache, dry skin, fatigue, hypertension, pyrexia, arthralgia, nausea, diarrhea, lipase increased, vomiting, myalgia and pain in extremity.

Citation:

Ariad announces FDA full approval and label update for Iclusig® (ponatinib) based on long-term efficacy and safety data from Phase 2 PACE clinical trial. [news release]. Cambridge, MA: Ariad Pharmaceuticals November 29, 2016. http://www.businesswire.com/news/home/20161129005510/en/ARIAD-Announces-.... Accessed December 5, 2016.

Iclusig [package insert]. Cambridge, MA: Ariad Pharmaceuticals, Inc 2016. http://www.ariad.com/files/1914/8044/8671/Iclusig-Prescribing-Informatio.... Accessed December 5, 2016.

This Week's Must Reads

Gene sequencing bone marrow in myelodysplastic syndrome, Duncavage EJ et al. N Engl J Med 2018;379:1028-41.

Levofloxacin prophylaxis in ALL, AML , Alexander S, et al. JAMA. 2018;320(10):995-1004

Genetic markers signal poor prognosis in MCL, Obr A et al. Clin Lymphoma Myeloma Leuk. 2018 Aug 23. doi: 10.1016/j.clml.2018.07.282

Disparities in ALL treatment toxicity, Taylor OA et al. Clin Cancer Res. 2018 Sep 11. doi: 10.1158/1078-0432.CCR-18-0939

Leukemia risk after maternal contraception use, Hargreave M et al. Lancet Oncol. 2018 Sep 6. doi: 10.1016/S1470-2045(18)30479-0

Must Reads in AML

Levofloxacin prophylaxis in ALL, AML , Alexander S, et al. JAMA. 2018;320(10):995-1004

Higher AML, MDS risk linked to autotransplants, Radivoyevitch T et al. Leuk Res. 2018 Jul 19. pii: S0145-2126(18)30160-7

Vadastuximab talirine improves AML remission rates, Fathi AT et al. Blood. 2018 Jul 25. doi: 10.1182/blood-2018-03-841171.

Tibsovo for AML with IDH1 mutation, FDA approves first targeted treatment for patients with relapsed or refractory acute myeloid leukemia who have a certain genetic mutation, FDA press release

Second filgrastim biosimilar approved by FDA, U.S. FDA Approves Pfizer’s Biosimilar NIVESTYM™ (filgrastim-aafi), Pfizer press release