Regulators in Europe have given the green light to Johnson & Johnson/Pharmacyclics’ closely-watched Imbruvica for two forms of blood cancer.
J&J’s Janssen unit noted that the European Commission has specifically approved Imbruvica (ibrutinib) 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 the drug, a first-in-class, once-daily, oral Bruton’s tyrosine kinase inhibitor, follows a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency in July.
Janssen quoted Peter Hillmen of St James’s University Hospital in Leeds as saying 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”.
He 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 was given the green light by the US Food and Drug Administration for MCL in November 2013 and full approval for CLL in July this year.
Jane Griffiths, chairman of Janssen, Europe, Middle East and Africa (EMEA), said the EC thumbs-up is a positive step forward for patients, and the company is “looking into further areas of unmet need in blood cancers where Imbruvica could improve outcomes”.
Earlier this week, Janssen and Pharmacyclics announced pacts to evaluate Imbruvica in combination with Bristol-Myers Squibb’s PD-1 immune checkpoint inhibitor Opdivo (nivolumab) for non-Hodgkin lymphoma and another combo with Roche’s Gazyva (obinutuzumab) for NHL and chronic lymphocytic leukaemia/small lymphocytic lymphoma.
