JNJ, AbbVie plan to pull US accelerated approvals for some blood cancer
treatments
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[April 07, 2023]
(Reuters) -AbbVie Inc and partner Johnson & Johnson intend to
voluntarily withdraw the accelerated approvals of their Imbruvica drug
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received at least one prior therapy will be withdrawn, the companies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.
![](http://archives.lincolndailynews.com/2023/Apr/07/images/ads/current/sunag_sda_SFARM_2023.png)
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.
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![](../images/040723PIX/health85.jpg)
A sign stands outside a Abbvie facility
in Cambridge, Massachusetts, U.S., May 20, 2021. REUTERS/Brian
Snyder
![](http://archives.lincolndailynews.com/2019/Sep/05/images/ads/current/stclara_lda_SPONSOR_090519.png) 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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