AbbVie Inc. ABBV said Monday the U.S. Food and Drug Administration has granted breakthrough therapy designation, or BTD, to its epocritamab treatment for relapsed or refractory (R/R) follicular lymphoma (FL) in adult patients. BTD is a process designed to expedite the development and review of drugs that are intended to treat a serious umet medical need. The company said the European Medicines Agency has validated a Type II application for epcoritamab for the same indication. If approved, it would become the second conditionally approved indication for the drug in the European Union. The moves come after the release of data from a Phase 1/2 trial involving128 adult patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin’s lymphoma (NHL), including FL. AbbVie’s stock was slightly higher premarket, but has fallen 14% in the year to date, while the S&P 500 SPX has gained 18.8%.
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