Ibrutinib indications for mantle cell, marginal zone lymphoma to be voluntarily withdrawn
Click Here to Manage Email Alerts
Janssen and Pharmacyclics intend to voluntarily withdraw the U.S. indications of ibrutinib for certain patients with lymphoma, according to a press release.
The withdraw applies only to ibrutinib indications for patients with mantle cell lymphoma who received at least one previous therapy and for patients with marginal zone lymphoma who need systemic treatment after at least one previous anti-CD20-based therapy, according to the press release from Janssen Pharmaceutical Companies of Johnson & Johnson. Treatment options for the rare non-Hodgkin lymphoma subtypes remain limited.
Ibrutinib (Imbruvica; Janssen, Pharmacyclics), a Bruton tyrosine kinase inhibitor, received accelerated approval in mantle cell lymphoma and marginal zone lymphoma based on overall response rates in separate phase 2 studies. The agent had to demonstrate clinical benefit in phase 3 confirmatory trials in order to receive continued approval.
The confirmatory SHINE study of ibrutinib among patients with previously untreated mantle cell lymphoma met its primary endpoint, showing a significant PFS benefit when added to chemoimmunotherapy. However, it did not demonstrate an OS advantage and appeared associated with increased adverse events vs. the placebo-controlled group.
The confirmatory SELENE study among patients with relapsed or refractory follicular lymphoma or marginal zone lymphoma failed to meet its primary endpoint of PFS. Results of the study will be presented at a future medical meeting.
FDA discussed the study results with the companies and deemed the primary outcomes insufficient to support conversion to full approval, according to the press release.
“We fully support the FDA accelerated approval pathway, which patients rely on for timely access to promising treatments that may improve or extend their lives,” Craig Tendler, MD, vice president of late development and global medical affairs for Janssen Research & Development, LLC, said in the press release. “While withdrawing these indications was a difficult decision, we remain confident in the benefit/risk profile of Imbruvica in its approved indications and are committed to its continued development.”
Read more about
Click Here to Manage Email Alerts