Janssen Reports the Submission of a Type II Variation Application to the EMA for the Approval of a New Indication for Imbruvica (ibrutinib) for MCL
- The company has submitted a Type II variation application to the EMA for approval of a new indication for Imbruvica (BTK inhibitor) + bendamustine and rituximab for patients with MCL who are unsuitable for ASCT
- The submission was supported on the P-III (SHINE) study to evaluate the efficacy and safety of ibrutinib + bendamustine and rituximab in 523 patients aged ≥65yrs. with newly diagnosed MCL. The trial met its 1EPs of PFS
- Ibrutinib is designed to block the BTK protein which is needed by normal and abnormal B-cells including specific cancer cells to multiply and spread. The therapy has been approved in the EU CLL, MCL & WM
Ref: J&J | Image: Janssen
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