EMA committee recommends full approval of Imbruvica to treat two blood cancers

The CHMP recommendation for Imbruvica is to treat adult patients with relapsed or refractory mantle cell lymphoma (MCL), or adult patients with chronic lymphocytic leukemia (CLL) who have 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.

The positive opinion was based on data from the Phase II trial (PCYC-1104) in MCL, and a Phase III RESONATE study (PCYC-1112-CA) and a Phase II study (PCYC-1102) in CLL.

Pharmacyclics chairman and CEO Bob Duggan said the company is happy with the CHMP’s positive opinion for a full approval and with their recognition of the statistically significant overall survival and progression-free survival benefits of ibrutinib in CLL, as well as the strength of our MCL data.

"Today, we are one big step closer to offering an important, potentially paradigm-changing, new treatment option to patients around the world with these complex and challenging blood cancers," Duggan said.

In the US, Imbruvica is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech.

Following approval, Janssen-Cilag International NV will be the marketing authorization holder in Europe.

Janssen will be responsible for marketing Imbruvica in Europe, Middle East, Africa (EMEA) region, as well as the rest of the world, outside of the US.

Imbruvica received accelerated approval from the US Food and Drug Administration (FDA) for two indications based on overall response rate to treat patients with MCL and CLL who have received at least one prior therapy.

Image: Pharmacyclics and Janssen Biotech are jointly developing and commercializing Imbruvica in the US. Photo: courtesy of PRNewswire.