The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the full marketing approval of Pharmacyclics’ Imbruvica (ibrutinib) in the EU for treatment of two blood cancers.
The CHMP’s positive opinion supports the use of Imbruvica to treat adult patients with relapsed or refractory mantle cell lymphoma (MCL), or adult patients with chronic lymphocytic leukemia (CLL) who received at least one prior therapy, or in first line in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.
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The European Commission will review the CHMP’s positive opinion for Imbruvica and is expected to issue a final decision later this year.
Imbruvica’s approval in the EU is based on positive data from the Phase II study (PCYC-1104) in MCL, and a Phase III Resonate study and a Phase II study (PCYC-1102) in CLL.
The Phase II study (PCYC 1104) evaluated the efficacy of ibrutinib in 111 patients with relapsed or refractory MCL.
Resonate is a Phase III, head-to-head study of a single-agent, orally-administered ibrutinib versus the intravenous monoclonal antibody ofatumumab targeting the CD 20 antigen. The study enrolled 391 relapsed or refractory patients with CLL/ small lymphocytic lymphoma.
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By GlobalDataIn the randomised, multi-centre study, single-agent ibrutinib showed a statistically significant improvement in progression-free survival, overall survival, and overall response rate, regardless of baseline characteristics, as compared with patients treated with ofatumumab.
Imbruvica is being jointly developed and commercialised in the US by Pharmacyclics and Janssen Biotech.
Once approved, Janssen-Cilag International will be the marketing authorisation holder in Europe. Janssen will market Imbruvica in Europe, Middle East, Africa, as well as the rest of the world, outside of the US.
The US Food and Drug Administration had granted accelerated approval for Imbruvica for two indications based on overall response rate for the treatment of patients with MCL and CLL.
Image: Pharmacyclics and Janssen Biotech are jointly developing Imbruvica in the US. Photo: courtesy of PRNewswire.
