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Impact of FDA Breakthrough Therapy Designation on the Regulatory Timelines of Chronic Lymphocytic Leukemia (CLL) Therapies

Time

Wed, Jun 18 7:15AM
W 32

Title

Impact of FDA Breakthrough Therapy Designation on the Regulatory Timelines of Chronic Lymphocytic Leukemia (CLL) Therapies

Abstract Summary

The study utilized publicly accessible NIH clinical trial registry for trial information as well as the FDA and sponsor company press releases for regulatory milestones and pivotal trial data for the breakthrough therapies obinutuzumab and ibrutinib, as well as the standard-of-care, rituximab.

Poster Presenter

Alex Wei
Student,
Ernest Mario School of Pharmacy, Rutgers University
United States