The FDA grants accelerated approval to Roche’s drug combo for lymphoma.
The approval was given to the company’s treatment, Polivy, when given as a cocktail with its oncology drug Rituxan and a chemotherapy treatment, bendamustine. The combo was designed to treat patients with an aggressive form of lymphoma that has not yet responded to other therapies.
A phase 1B/2 study showed that the cancer was not detected in 40 percent of patients who received the pairing, compared to 18 percent who were given Rituxan and chemo alone. As part of the approval, Roche will need to perform a confirmatory trial.
The FDA’s accelerated approval process fast-tracks drugs onto the market that target serious, unmet medical needs.
“Today’s approval of this Polivy combination will provide a novel treatment that is both immediately available and very much needed for people with this aggressive disease,”the company said in a statement.
Read the full press release.