List view / Grid view

Imbruvica (ibrutinib)

Filter the results

 

news

NICE says Novartis’ and Janssen’s cancer drugs are not cost effective

18 August 2016 | By The National Institute for Health and Care Excellence (NICE)

In new draft guidance, the National Institute for Health and Care Excellence (NICE) has advised that everolimus, for treating advanced breast cancer after endocrine therapy, and ibrutinib, for treating relapsed or refractory mantle cell lymphoma, two drugs on the Cancer Drugs Fund are not cost effective. 

news

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.

news

NICE asks Janssen to put ibrutinib forward for the CDF

1 June 2016 | By Victoria White, Digital Content Producer

The National Institute for Health and Care Excellence (NICE) has asked Janssen to set out a case for including its chronic lymphocytic leukaemia (CLL) drug ibrutinib (Imbruvica) in the Cancer Drugs Fund (CDF).

news

Ibrutinib shown to be superior to chlorambucil in trial

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.

news

Imbruvica Phase III combination data submitted to the FDA

13 November 2015 | By Victoria White

AbbVie has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for labelling considerations based on safety and efficacy results from the Phase III HELIOS trial investigating the use of Imbruvica (ibrutinib) plus bendamustine and rituximab (BR) versus placebo plus BR in relapsed or…

news

Janssen submits application to EMA to expand use of ibrutinib

4 November 2015 | By Victoria White

Janssen-Cilag International has submitted a Type II variation application to the European Medicines Agency (EMA), which seeks to broaden the existing marketing authorisation for Imbruvica (ibrutinib) to include previously untreated patients with chronic lymphocytic leukaemia (CLL).