Janssen announces submission of supplemental new drug application to U.S. FDA seeking approval of Imbruvica (ibrutinib) in combination with rituximab for previously untreated patients with chronic lymphocytic leukaemia

Janssen

8 November 2019 - Supplemental new drug application -- submitted through FDA real-time oncology review program -- is based on positive Phase 3 data in patients aged 70 or younger.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental new drug application to the U.S. FDA seeking approval to expand the Imbruvica (ibrutinib) label to include the combination with rituximab for the first-line treatment of patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma. 

The submission is based on positive results from the investigational Phase 3 E1912 study designed and conducted by the ECOG-ACRIN Cancer Research Group and sponsored by the National Cancer Institute, which is part of the National Institutes of Health.

Read Janssen press release

Michael Wonder

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Michael Wonder

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Cancer , Medicine , US , Dossier