Roche gets thumbs up for CLL use of Gazyvaro in EU

Gazyva, Roche's ($RHHBY) successor to Rituxan, is already approved in the U.S. for first-line use on chronic lymphocytic leukemia (CLL) and appears poised for the same in Europe. The EU Committee for Medicinal Products for Human Use (CHMP) today recommended it for approval there. Approval will better position Gazyvaro, as it is named outside the U.S., to fill the looming revenue gap Roche expects when biosimilars of its bestseller Rituxan hit the market.

The recommendation is for Gazyvaro to be used in combination with chlorambucil for untreated CLL to be used for first-line treatment of CLL in patients who are not suitable for full-dose fludarabine therapy. A recommendation is generally followed by approval within several months.

Roche has indicated the drug is seeing solid uptake in the U.S. since the FDA approved it in November. CLL is the most common form of leukemia in adults, and the National Cancer Institute estimates there were more than 15,680 new cases and more than 4,580 deaths in the U.S. last year, meaning it is a serious problem and a significant market. And the market potential in Europe may be even greater. Roche said today that it is estimated about 10,000 deaths a year are attributed to the cancer.

But Roche is not without competition in the category. The FDA in April granted Arzerra, the drug that GlaxoSmithKline ($GSK) shares with Genmab, approval for first-line use on CLL. The partners are seeking the same designation in Europe as well.

Roche is in a bit of a race with Gazyva, hoping to move patients to the drug before the patent on Rituxan expires in 2018. With global sales of $7.778 billion last year, Rituxan is the target of a number of biosimilar developers who want a piece of that action. The Swiss drugmaker has data that shows Gazyva works better than Rituxan, giving it hope that doctors will make the switch and some significant piece of Rituxan sales will transfer to Gazyva before generic competition starts eating away Rituxan sales.

- here's the announcement