FDA Approves More Convenient Form of Roche Blood Cancer Drug

By Reuters Staff

June 23, 2017

(Reuters) - U.S. health regulators on Thursday approved a new formulation of Roche's big-selling cancer drug Rituxan (rituximab) for three common types of blood cancers that allows for relatively quick administration via injection under the skin in place of a lengthy intravenous infusion, the company said.

The new formulation, to be sold under the name Rituxan Hycela, combines the medicine with an enzyme that can deliver the active ingredient with a subcutaneous injection in five to seven minutes compared with an infusion that typically takes 90 minutes or longer.

The Food and Drug Administration approved Rituxan Hycela to treat adults with follicular lymphoma, diffuse large B-cell lymphoma or chronic lymphocytic leukemia, Roche's Genentech unit said.

The FDA approval is based on clinical studies that demonstrated that subcutaneous administration of Rituxan Hycela resulted in similar levels of the antibody in the blood with comparable clinical efficacy compared with intravenous Rituxan.

The new formulation will be available to U.S. patients in one to two weeks, the company said. Regular IV Rituxan will also still be available.

Rituxan, which is beginning to face competition from less expensive biosimilar rivals in Europe, had global sales of about $7.5 billion in 2016.

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