Roche’s combo lymphoma treatment wins FDA’s accelerated approval

(Reuters) – The U.S. Food and Drug Administration granted accelerated approval to Roche Holding AG’s combo lymphoma treatment for previously treated patients, the company said on Monday.

The drug, Polivy, is used in combination with Rituxan and a chemotherapy agent to treat an aggressive form of the disease.

The combo is used to treat adults, who have received at least two prior therapies for relapsed or refractory form of non-Hodgkin’s lymphoma (NHL).

Roche estimates that nearly 25,000 new cases to be recorded in the United States this year.

NHL, which is one of the most common cancers in the United States, accounts for about 4% of all types of cancers, according to the American Cancer Society.

Continued approval for the treatment may depend on data from a confirmatory trial, Roche said.

The FDA’s accelerated approval program allows conditional approval of a medicine that fills an unmet medical need for a serious condition.