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Roche blood cancer drug Polivy gets conditional European Commission nod

Roche Holding AG said the European Commission granted conditional approval to Polivy, in combination with chemotherapy drug Treanda and MabThera, for treating a type of blood cancer.

The European regulator granted conditional marketing authorization to the regimen for treating adult patients with diffuse large B-cell lymphoma who are not candidates for a hematopoietic stem cell transplant and whose disease returned or did not respond to prior therapy.

The European Commission grants conditional approval to medicinal products that fulfill an unmet need where the benefit of immediate availability outweighs the risk of less comprehensive data.

Polivy's approval was based on results from the phase 1b/2 GO29365 study, during which 40% of patients treated with the drug combination experienced a disappearance of all signs of cancer compared with 18% of patients who received Roche's MabThera and Treanda, or bendamustine, alone.

The European Commission nod comes after the European Medicines Agency granted conditional marketing authorization for Polivy, or polatuzumab vedotin, regimen in November 2019.

The combination was also granted accelerated approval by the U.S. Food and Drug Administration in June 2019 to treat diffuse large B-cell lymphoma in patients whose disease has recurred after two lines of therapies, or has not responded to prior treatment.