Regulatory

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

Jonathan G. Drachman

A little more than two months after the FDA put a clinical hold on early-stage work of its armed antibody dubbed SGN-CD33A (vadastuximab talirine) in acute myeloid leukemia following the deaths of 4 patients, the agency has come back to lift the hold and give Seattle Genetics the green light to continue.

Moving forward, the biotech says it’s implementing added risk mitigation measures in all vadastuximab talirine studies, including “revised eligibility criteria and stopping rules for veno-occlusive disease.”

Seattle Genetics has been attracting some positive attention for this program from analysts looking for the biotech to expand its portfolio beyond Adcetris. The biotech launched its late-stage study in May after posting positive Phase I data from a combination study reviewed at ASH.

Data demonstrated that 15 of 23 (65 percent) evaluable patients achieved CR/CRi. At a median follow-up of 7.7 months, median survival had not yet been reached, and 72 percent of patients remained alive and on study.

Some of the analysts who follow the company expected a quick resolution of the hold, and they weren’t disappointed. Seattle Genetics stock was down slightly Monday afternoon.

“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,” said Chief Medical Officer Jonathan Drachman. “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).”


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RAPS Regulatory Convergence 2017