EMA Approves Blood Cancer Drug Imbruvica for Two Indications

The European Medicines Agency has approved Janssen and Pharmacyclics’ blood cancer drug Imbruvica for two indications, a move that follows similar approvals in the U.S. this summer.

Imbruvica (ibrutinib) will be indicated as a second-line treatment for adults with relapsed or refractory mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL) or as a first-line treatment for CLL patients with a 17p deletion or TP53 mutation, Pharmacyclics says.

There are few first-line treatments available for MCL and CLL, Janssen spokesman Satu Glawe said, and many of these consist of chemotherapy. Imbruvica not chemotherapy and can be taken once a day at home. The drug works by inhibiting a signaling molecule in the chain that leads to survival and spread of cancerous B cells.

The approval follows various Phase I, II and III studies in both indications that showed patients with MCL had a median response duration of 17.5 months and median progression-free survival of 15.3 months. CLL patients showed statistically significant gains in progression-free survival, overall survival and overall response rate, the companies said.

The companies say they are now studying the drug for other MCL and CLL indications on its own and in combination with other therapies in more than 35 clinical trials around the world. The drug also is being tested to treat other blood cancers, such as Waldenström's macroglobulinemia, diffuse large B-cell lymphoma, follicular lymphoma and multiple myeloma.

Imbruvica won FDA approval for CLL and for MCL in July. — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.