Minimal Residual Disease Endpoint Would Aid Leukemia Drug Development, Experts Say
An international panel of hematology experts tells an FDA/ASCO workshop Feb. 27 that minimal residual disease would be a useful surrogate endpoint for assessing the effects of chronic lymphocytic leukemia therapies because it has been strongly correlated with longer-term outcomes in the disease.
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More work needs to be done to validate MRD as predictive of clinical outcomes in hematological malignancies before it can be used as the basis for accelerated approval, FDA and other stakeholders say.
US FDA is reviewing confirmatory trial data that suggest a ‘detriment in survival’ with Oncopeptides’ alkylating agent in relapsed/refractory multiple myeloma and may convene its Oncologic Drugs Advisory Committee to explore continued marketing for patients who received at least four prior lines of therapy.
Advisory committee will discuss five types of toxicity risks with adeno-associated virus vector-based gene therapy products at a two-day meeting in September, which follows some recent high-profile instances of adverse events that have delayed development programs.