FDA Advisers Back Marqibo for Ph-Negative ALL
FROM A MEETING OF THE FOOD AND DRUG ADMINISTRATION'S ONCOLOGIC DRUGS ADVISORY COMMITTEE
Talon posited that patients who went on to bone marrow transplant after treatment should be counted as responders, but the agency noted that of the 12 patients who had transplants, only 5 were actually responders.
The agency’s reviewers also raised questions about Marqibo’s safety, which was judged on an 83-patient database. A third of patients (27 of 83) had a grade 3 or greater adverse event. Twenty percent (17) missed a dose, and 22% (18) had a dose reduction. Twenty-three percent of patients died on study.
Talon said that adverse events and patient deaths were in line with what would be expected for the ALL population, especially one with so much prior vincristine exposure.
By law, the FDA must act on Talon’s accelerated approval application by May 13.
