(Reuters) -AbbVie Inc and partner Johnson & Johnson intend to voluntarily withdraw the accelerated approvals of Imbruvica in the U.S. for patients with certain types of blood cancer, the companies said on Thursday.
The U.S. Food and Drug Administration (FDA) advised that the primary outcomes from late-stage studies of the drug for the indications were considered insufficient to support conversion to full approval, J&J said.
Accelerated approvals of Imbruvica to treat patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, and those with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior therapy will be withdrawn, the companies said.
A late-stage study in previously untreated MCL patients met its main goal of progression-free survival. But addition of the drug to chemoimmunotherapy was associated with increased adverse reactions compared to the placebo-controlled arm, the companies said.
A late-stage study for relapsed or refractory MZL did not meet the main goal of progression-free survival.
Imbruvica was approved in these indications based on overall response rates in mid-stage studies.
The U.S. health regulator grants the so-called accelerated approval mainly for drugs and therapies targeted at rare diseases or small patient populations that have had no effective treatments available to them.
Companies are still required to conduct studies to confirm the anticipated clinical benefit.
The withdrawal will not affect other approved indications for the drug in the U.S., the companies said on Thursday.
“We are confident of the benefit/risk profile of Imbruvica in its approved indications and are committed to its continued development,” J&J said.
The FDA did not immediately respond to Reuters’ request for comment.
(Reporting by Sriparna Roy in Bengaluru; Editing by Shilpi Majumdar)
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