(Reuters) – AbbVie Inc intends to voluntarily withdraw in the U.S. the accelerated approvals of its Imbruvica drug for patients with certain types of blood cancer, the drugmaker said on Thursday.
The company plans to voluntarily withdraw accelerated approvals of Imbruvica for patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, and with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior therapy.
A late-stage study in previously untreated MCL met its main goal of progression-free survival, the one for relapsed or refractory MZL did not meet the main goal, the company said.
The drug was approved in these indications based on overall response rates in a mid-stage study, the company said, adding that the U.S. Food and Drug Administration (FDA) requires additional studies to confirm the clinical benefit following accelerated approvals.
Other approved indications for Imbruvica in the U.S. are not affected, the company said.
The FDA did not immediately respond to Reuters’ request for comment.
(Reporting by Sriparna Roy in Bengaluru; Editing by Shilpi Majumdar)
