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Janssen Biotech Inc.

 

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FDA grants Breakthrough designation to ibrutinib in cGVHD

1 July 2016 | By Victoria White, Digital Content Producer

The US Food and Drug Administration (FDA) has granted a fourth Breakthrough Therapy Designation for ibrutinib (Imbruvica) as monotherapy for the treatment of patients with chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy.

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IMBRUVICA™ (ibrutinib) capsules now approved in the U.S. for Mantle Cell Lymphoma patients who have received at least one prior therapy

13 November 2013 | By Johnson & Johnson

Janssen Biotech, Inc. [“Janssen”] today announced the U.S. Food and Drug Administration (FDA) has approved IMBRUVICA™ (ibrutinib) capsules for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.1 This indication is based on overall response rate (ORR). An improvement in survival or…