AbbVie (NYSE:ABBV) and Janssen Pharmaceutical (NYSE:JNJ) have revealed their intent to voluntarily withdraw the accelerated approvals for Imbruvica (ibrutinib) for patients with mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL) in the U.S.
Ibrutinib is a selective Bruton’s tyrosine kinase (BTK).
The main reasons for the move relate to FDA’s request for additional studies to confirm clinical benefits that relate to the accelerated approval status granted by the FDA for MCL and MZL. Initially, FDA authorized the accelerated approval program for the two indications following the publication of positive overall response rate data in phase 2 trials.
While the phase 3 shine study in previously untreated MCL met its primary endpoint of progression-free survival, there was an increased rate of adverse reactions when combining Imbruvica and chemotherapy compared to the placebo-controlled arm.
Conversely, the phase 3 SELENE study in re…