European Regulators Recommend Janssen’s Imbruvica

European Regulators Recommend Janssen’s ImbruvicaThe European regulatory body has granted approval to Pharmacyclics’ / Johnson & Johnson’s Janssen unit’s Imbruvica for two types of blood cancer.

The European Commission has specifically approved the drug for mantle cell lymphoma (MCL) or patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy, or first-line in those with the chromosomal abnormalities deletion 17p or TP53 mutation.

Approval for Imbruvica follows a previous positive response from the Committee for Medicinal Products for Human Use of the European Medicines Agency in July 2014.

Johnson & Johnson’s Janssen unit quoted Peter Hillmen of St James’s University Hospital in Leeds as commenting that MCL and CLL with 17p deletion “are usually challenging and difficult-to-treat blood cancers that do not respond well to conventional therapies. They usually rapidly progress during or soon after chemotherapy leaving patients with very limited treatment options and poor survival.”

Peter Hillmen added that being able to use Imbruvica as a single agent “offers a new option and gives renewed hope for physicians and their patients.”

The drug has previously also received regulatory approval by the US Food and Drug Administration (FDA) for mantle cell lymphoma in November 2013 and full approval for chronic lymphocytic leukaemia in July 2014.

Chairman of Janssen, Europe, Middle East and Africa (EMEA), Jane Griffiths, commented that the European Commission recommendation is a positive step forward for patients, and noted that Janssen is “looking into further areas of unmet need in blood cancers where Imbruvica could improve outcomes.”

Earlier this week, Janssen and Pharmacyclics announced agreements to evaluate Imbruvica in combination with Roche’s Gazyva for NHL and chronic lymphocytic leukaemia/small lymphocytic lymphoma, and Bristol-Myers Squibb’s PD-1 immune checkpoint inhibitor Opdivo for non-Hodgkin lymphoma.


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