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Roche’s Polivy recommended by NICE for lymphoma therapy

Around 5,500 people in England are diagnosed with the aggressive blood cancer each year


Roche’s Polivy (polatuzumab vedotin) has been recommended by the National Institute for Health and Care Excellence (NICE) as part of a drug combination to treat adults with an aggressive form of blood cancer.

In final draft guidance, NICE recommended the antibody drug conjugate be used in combination with rituximab, cyclophosphamide, doxorubicin and prednisolone (R-CHP) for untreated diffuse large B-cell lymphoma (DLBCL).

Around 5,500 people are diagnosed with DLBCL each year in England. The disease can develop at any age, but most patients are diagnosed at the age of 65 years or older.

Common symptoms include painless swellings at single or multiple sites, excessive night sweating, unexplained fever and weight loss.

Currently, the standard treatment for untreated DLBCL is the combination of rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone (R-CHOP), which NICE reports as only being effective in 50-70% of patients.

‘The chance for a long-term cure for DLBCL diminishes with each subsequent line of therapy,’ the organisation explained in its final guidance. ‘Therefore, obtaining the best possible outcome for previously untreated patients is of critical importance.’

The recommendation is supported by clinical evidence that suggests that patients taking Polivy with R‑CHP have more time before their cancer progresses than those receiving R‑CHOP.

A randomised control trial found that patients treated with Polivy in combination with R‑CHP had a 24-month progression-free survival rate of 76.7%, compared with 70.2% for those who received R‑CHOP.

“We are delighted with today’s news that patients in England will now be able to access this treatment," said Pia Ballschmieter, Haematology Lead, Roche Products Limited. "After decades with very limited treatment advances, this approval marks a new era for people battling aggressive DLBCL."

Roche has a commercial arrangement to make Polivy available to the NHS at a discount and estimates that around 1,862 patients in England are eligible to receive the new treatment.

In May 2022, the Polivy/ R-CHP combination was approved by the European Commission, also for adult patients with untreated DLBCL.

“After more than 20 years with very limited treatment advances, the approval of Polivy plus R-CHP marks a new era for people battling this aggressive disease,” said Levi Garraway, Roche’s chief medical officer and head of global product development at the time of the announcement.

Roche’s supplemental biologics licence application for the Polivy combination therapy was also accepted by the US Food and Drug Administration for the same indication in August 2022, with a final decision expected by April this year.

Article by
Emily Kimber

2nd February 2023

From: Regulatory



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