Roche gets conditional approval in Europe for lymphoma therapy
Roche announced on Tuesday that the European Commission has granted conditional marketing authorisation for ‘Polivy’ (polatuzumab vedotin), in combination with bendamustine plus ‘MabThera’ (rituximab), for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma who were not candidates for a haematopoietic stem cell transplant.
The Swiss pharmaceutical giant said the conditional approval was based on the results from the phase 1b and 2 ‘GO29365’ study, which was the first and only clinical trial to show higher response rates and improved overall survival compared to the commonly used regimen of bendamustine plus MabThera (BR), in people with relapsed or refractory diffuse large B-cell lymphoma who were not candidates for a haematopoietic stem cell transplant.
Results of the study showed that 40% of people treated with Polivy plus BR achieved a complete response, meaning no cancer could be detected at the time of assessment, compared to 17.5% with BR alone.
Complete response rates were assessed by an independent review committee, Roche said.
The study also showed that overall survival more than doubled, with a median of 12.4 months in the Polivy arm compared to 4.7 months in the BR alone arm.
Additionally, patients treated with Polivy plus BR showed a longer time between first response to treatment and disease worsening than those receiving BR alone.
The most commonly-reported adverse events in people treated with Polivy in combination with BR included anaemia, thrombocytopenia, neutropenia, fatigue, diarrhoea, nausea, and pyrexia.
Roche explained that conditional approval is granted to a medicinal product that fulfils an unmet medical need, where the benefit of immediate availability outweighs the risk of less comprehensive data than normally required.
It said the conditional EU approval followed the US Food and Drug Administration’s (FDA) accelerated approval of Polivy in combination with BR for the treatment of people with relapsed or refractory diffuse large B-cell lymphoma who had received at least two prior therapies, in June.
Polivy was granted ‘breakthrough therapy designation’ by the FDA and ‘priority medicines’ (PRIME) designation by the European Medicines Agency (EMA) for the treatment of people with relapsed or refractory diffuse large B-cell lymphoma in 2017, which was the first PRIME designation for a Roche medicine.
Additional submissions of the GO29365 data to health authorities around the world were ongoing, the board said, with the goal of bringing the new treatment option to more patients as soon as possible.
“With this approval, people in the EU with relapsed or refractory diffuse large B-cell lymphoma will have the opportunity to benefit from this new Polivy combination,” said Roche’s chief medical officer and head of global product development Levi Garraway.
“For patients battling this aggressive disease, the prognosis is poor and few treatments are available.
“We are proud to bring this first-in-class treatment option to those who need it most.”