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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.
7 December 2015 | By Victoria White
Janssen-Cilag International NV has announced data from the Phase 3 RESONATE-2 (PCYC-1115) trial that show ibrutinib (Imbruvica) was superior to chlorambucil in all efficacy endpoints measured in patients with treatment-naïve chronic lymphocytic leukaemia or small lymphocytic lymphoma (CLL/SLL) aged 65 or older.
14 September 2015 | By Victoria White
A supplemental New Drug Application (sNDA) for Imbruvica (ibrutinib) has been submitted to the US Food and Drug Administration (FDA) for front-line use in patients with chronic lymphocytic leukaemia (CLL).
13 October 2014 | By Bristol-Myers Squibb Company
Bristol-Myers Squibb Company (NYSE:BMY), Pharmacyclics, Inc. (NASDAQ:PCYC), and Janssen Research & Development, LLC announced today they have entered into a clinical trial collaboration agreement to evaluate the safety, tolerability and preliminary efficacy of Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor OPDIVO® (nivolumab) in combination with IMBRUVICA® (ibrutinib), an oral Bruton's…
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…
21 February 2013 | By Abbott
Abbott will collaborate with Janssen Biotech and Pharmacyclics to explore the benefits of Abbott's proprietary FISH technology...
8 December 2011 | By Johnson & Johnson
Compound in development for multiple B-cell hematologic malignancies...
