Gilead, Janssen-Cilag Cancer Drugs, Allergan Eye Treatment Recommended by EU Advisors

A key European advisory panel gave positive opinions for Gilead’s Zydelig and Janssen-Cilag’s Imbruvica to treat various forms of rare blood cancers and a new indication for Allergan’s Ozurdex to treat the eye disorder diabetic macular edema.

The recommendations by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) now go before the European Commission, which will make a final decision on market authorization.

Both Zydelig (idelalisib) and  Imbruvica (ibrutinib) received the green light to treat adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior treatment, and as a first-line treatment for patients with a specific genetic mutation making them unsuitable for chemo-immunotherapy.

In addition, CHMP recommended Zydelig for treatment in adults with follicular lymphoma that have not responded to two previous treatments, and recommended Imbruvica for use in adults with mantle cell lymphoma that has come back after previous treatments or is not responding to other treatments.

The European recommendation for Zydelig follows the FDA’s July 22 approval of the drug to be used in combination with Genentech’s Rituxan (rituximab) to treat patients whose CLL has returned and patients with relapsed follicular B-cell non-Hodgkin lymphoma and relapsed small lymphocytic lymphoma. The FDA approved Imbruvica Feb. 12 for chronic lymphocytic leukemia patients who have received at least one previous therapy.

The drugs will go head-to-head in the lucrative cancer drug market. Research firm EvaluatePharma estimated that Zydelig will generate up to $1.2 billion in annual sales by 2020.

Ibrutinib was co-developed by Janssen and Pharmacyclics Switzerland GmbH. Once approved, Janssen will market the drug everywhere except in the U.S., where both firms co-market it.

Last Friday, the CHMP also recommended approval of a new indication for the steroid implant Ozurdex (dexamethasone intravitreal implant) to treat adult patients who lost vision due to diabetic macular edema, who have an artificial lens implant or can’t take non-corticosteroid therapy.

Ozurdex already was approved in Europe to treat macular edema in patients with retinal vein occlusion and for inflammation, Allergan said. The FDA last month approved a new indication for Ozurdex to treat diabetic macular edema in patients that have a lens implant or are scheduled for cataract surgery. — Robert King, Jonathon Shacat

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