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FDA committee supports Roche’s lymphoma treatment

Published on 10/03/23 at 11:38am

 A committee at the FDA have voted in favour of Roche’s Polivy antibody drug targeting untreated diffuse large B cell lymphoma, which is the most common form of non-Hodgkin lymphoma in the US.

Roche has said that the oncologic drugs advisory committee voted 11 to 2 in favour of the drug in combination with Rituxan and cyclophosphamide, doxorubicin and prednisone to treat the disease, however this is not yet an official approval. This committee only supplies the FDA with independent opinions and recommendations, however an official FDA decision is expected by 2 April 2023.

This recommendation follows positive data from a phase 3 study that Roche shared late last year. This study demonstrated that Polivy in combination with other drugs can significantly reduce a patient’s risk of disease deterioration or death from untreated diffuse large B cell lymphoma. Most patients in the trial reported clinically meaningful improvements in lymphoma treatments following a first cycle of treatment, according to Roche back in December 2022.

The combination of Polivy drugs has already been approved in over 60 countries, including those in the EU, UK, and Japan, Canada and China.

Levi Garraway, Roche’s chief medical officer and head of global product development, commented: “Today’s committee decision to recognise the potential of this Polivy combination as a first line treatment is important since four in ten people with diffuse large B cell lymphoma relapse or do not respond to initial treatment.”


Betsy Goodfellow

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