Imbruvica® (ibrutinib) plus Venclexta®/Venclyxto® (venetoclax) resulted in 95 percent of chronic lymphocytic leukaemia patients surviving without disease progression for two years.
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Imbruvica® (ibrutinib) plus ventoclax and single-agent Imbruvica induced remissions lasting up to seven years in first-line treatment of chronic lymphocytic leukaemia.
FDA approves IMBRUVICA® (ibrutinib) for treatment of chronic lymphocytic leukaemia and small lymphocytic lymphoma
IMBRUVICA (ibrutinib), in combination with rituximab, has been given approval in the US for the treatment of chronic lymphocytic leukaemia and small lymphocytic lymphoma.
The European Commission has approved the drug for two indications: chronic lymphocytic leukaemia and Waldenström's macroglobulinemia.
2 December 2016 | By Niamh Louise Marriott, Digital Editor
Ibrutinib had only previously been available through the CDF. Following a reduction in its price for the NHS, it is now recommended in further guidance...
17 October 2016 | By Niamh Louise Marriott, Digital Content Producer
The National Institute of Health and Care Excellence (NICE) has published draft guidance that does not recommend Janssen’s Imbruvica (ibrutinib) for treating some people with Waldenstrom’s macroglobulinaemia – a rare type of slow growing non-Hodgkin’s lymphoma.
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In new draft guidance, the National Institute for Health and Care Excellence (NICE) has advised that everolimus, for treating advanced breast cancer after endocrine therapy, and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.
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.
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).
31 May 2016 | By Victoria White, Digital Content Producer
The European Commission (EC) has approved Imbruvica (ibrutinib) for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
3 May 2016 | By Mandy Parrett, Editorial Assistant
Janssen-Cilag International NV have reported that their therapy IMBRUVICA® (ibrutinib) has received a ‘Positive Opinion’ from the CHMP recommending that its use be extended for CLL patients.
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.
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…
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).