Other indications for the blockbuster cancer mediation are not affected.
AbbVie is voluntarily withdrawing the FDA’s accelerated approval of Imbruvica (ibrutinib) in the U.S. for two blood cancer indications.
The drugmaker is withdrawing approvals for patients with the blood cancers 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 anti-CD20-based therapy.
However, other approved indications for the blockbuster cancer medication — which netted nearly $4.6 billion in sales last year — are not affected, the company said.
The other approved indications for Imbruvica, a Bruton’s tyrosine kinase inhibitor, include chronic lymphocytic leukemia, Waldenström macroglobulinemia, adult chronic graft versus host disease and pediatric chronic graft versus host disease.
The voluntary action is linked to phase 3 studies that showed increased adverse reactions with Imbruvica, along with not meeting progression-free survivalendpoints. AbbVie’s Phase 3 SHINE (NCT01776840) study in previously untreated MCL and the Phase 3 SELENE study (NCT01974440) in relapsed or refractory MZL served as confirmatory studies for the accelerated approval indication.
While the SHINE study met its primary endpoint of progression-free survival, the addition of Imbruvica to chemoimmunotherapy was associated with increased adverse reactions compared to the placebo-controlled arm, according to AbbVie. The SHINE study results were presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The New England Journal of Medicine.
The SELENE study did not meet its primary endpoint of PFS. Those results will be presented at a future scientific forum.
“We pursued accelerated approvals for MCL and MZL indications for Imbruvica in the U.S. to offer a treatment to patients who at the time had limited therapeutic options,” said Roopal Thakkar, M.D., senior vice president, chief medical officer, AbbVie. “While we are disappointed in the outcome of the confirmatory trials for these indications, we remain confident in the benefit/risk profile of Imbruvica for patients living with multiple forms of blood cancer around the world.”
Imbruvica remains “the most comprehensively studied and prescribed cancer treatment in its class,” AbbVie said, adding that the medication “remains an important therapy for patients and healthcare professionals around the world.”