Roche’s Polivy Among Seven New Drugs On Track For EU-Wide Approval

The European Medicines Agency today said it had recommended for EU-wide marketing approval seven new drugs, including two orphans – Roche's Polivy (polatuzumab vedotin), for treating diffuse large B-cell lymphoma (DLBCL), and Novartis's Isturisa (osilodrostat), for the treatment of Cushing’s syndrome.

As was the case with Polivy’s approval in the US in June, the EMA’s drug evaluation committee, the CHMP, has recommended that the drug receive a conditional approval for treating relapsed/refractory DLBCL in combination with bendamustine and Roche’s MabThera (rituximab). The recommendation for conditional marketing authorization means that Roche will likely have to provide comprehensive clinical data at a later stage