Johnson & Johnson submits application to the European Medicines Agency seeking approval of a new indication for IMBRUVICA® (ibrutinib) in adult patients with previously untreated mantle ce...
Johnson & Johnson (JNJ)
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immunochemotherapy, both with and without an autologous stem cell transplant, followed by 24 months fixed-duration ibrutinib therapy Both ibrutinib-based regimens, transplant-free and with transplant, delivered clinically meaningful improvement in efficacy compared to the current standard of care of induction immunochemotherapy followed by transplant BEERSE, BELGIUM, Dec. 18, 2024 (GLOBE NEWSWIRE) -- Janssen-Cilag International NV, a Johnson & Johnson company, today announced the submission of a Type II variation application to the European Medicines Agency (EMA). The submission seeks approval for an indication extension of IMBRUVICA ® (ibrutinib) in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL), who are eligible for autologous stem cell transplant (transplant). This regulatory submission is supported by data from the TRIANGLE study, conducte
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JNJ
Earnings
- 10/15/24 - Beat
JNJ
Sec Filings
- 12/12/24 - Form 4
- 12/12/24 - Form 4
- 12/12/24 - Form 4
- JNJ's page on the SEC website