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The FDA lifts clinical hold on the phase I trials of vadastuximab talirine in AML

Mar 8, 2017

On 6 thMarch 2017, the U.S. Food and Drug Administration(FDA) lifted a clinical hold on the phase I clinical trials of experimental drug vadastuximab talirine (SGN-CD33A; a CD33-directed antibody drug conjugate) for patients with Acute Myeloid Leukemia (AML).

In January 2017, the AML Global Portal(AGP) reportedon the clinical hold placed on a phase I/II trial  of vadastuximab talirine by the FDA after four patients who were treated with this agent along with Allogeneic Hematopoietic Cell Transplant (AHCT), either prior to or following treatment, died. Additionally, a partial clinical hold was placed on phase I trials of vadastuximab talirine consisting of no further enrollment of new patients.

After a comprehensive analysis of clinical data from 300 AML patients who were treated with vadastuximab talirine by an independent committee of clinical experts and collaborations with the FDA, the FDA lifted the clinical hold placed on the phase I trials with vadastuximab talirine.

As a result, Seattle Genetics, the drug’s manufacturers, have said that they will resume two of the phase I trials in AML. One of these phase I trials is designed to evaluate the safety profile of vadastuximab talirine in combination with hypomethylating agents in newly diagnosed and relapsed AML patients ( NCT01902329). The other phase I trial is designed to assess the safety profile of vadastuximab in combination treatment with standard of care, or 7+3 chemotherapy, in newly diagnosed younger AML patients ( NCT02326584). However, the phase I/II clinical trials of vadastuximab talirine in pre- and post-AHCT patients will not be resumed.

Nonetheless, the phase III CASCADEtrial in older AML patients is still proceeding with enrolment.

  1. Business Wire: FDA Lifts Clinical Hold on Seattle Genetics’ Phase 1 Trials of Vadastuximab Talirine. 2017 Mar 6. http://www.businesswire.com/news/home/20170306005337/en/.[Accessed 2017 Mar 8].