FDA lifts its hold on vadastuximab talirine after Seattle Genetics adds new safeguards

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March 6, 2017

The FDA has given Seattle Genetics the green light to continue the trials for its armed antibody dubbed SGN-CD33A (vadastuximab talirine) used for the treatment of acute myeloid leukemia. The biotech says it is implementing additional risk mitigation measures in all vadastuximab talirine studies, including “revised eligibility criteria and stopping rules for veno-occlusive disease.” Two months ago, FDA put a clinical hold on the early-stage work of this trial following the deaths of 4 patients.

Seattle Genetics wanted to expand its portfolio beyond Adcetris and has been attracting some positive attention for this program from analysts, who followed the company and expected a quick resolution of the hold, and they weren’t disappointed.

Chief Medical Officer of Seattle Genetics, Jonathan Drachman, said: “We will resume two Phase I trials in AML and plan to initiate a randomized Phase II trial during 2017 evaluating vadastuximab talirine in combination with standard of care chemotherapy in frontline, younger AML patients. In addition, we are continuing to enroll our ongoing Phase III randomized CASCADE trial in frontline older AML patients and our phase 1/2 trial in frontline high-risk myelodysplastic syndrome (MDS).”

FDA lifts its hold on vadastuximab talirine after Seattle Genetics adds new safeguards last edit: 2017-03-16T07:11:59+00:00 da Luca

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