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Roche’s Polivy backed by FDA Advisory Committee for lymphoma therapy

Around 160,000 people worldwide are estimated to be diagnosed with DLBCL each year


Roche’s Polivy (polatuzumab vedotin) has been recommended by a US Food and Drug Administration’s (FDA) panel of experts as part of a drug combination to treat adults with an aggressive form of blood cancer.

The Oncologic Drugs Advisory Committee (ODAC) voted 11 to two in favour of the antibody drug conjugate being used in combination with rituximab, cyclophosphamide, doxorubicin and prednisolone (R-CHP) for untreated diffuse large B-cell lymphoma (DLBCL).

Around 160,000 people worldwide are estimated to be diagnosed each year with DLBCL, the most common form of non-Hodgkin lymphoma. The disease can develop at any age, but most patients are diagnosed at age 65 or older.

Currently, the standard treatment for untreated DLBCL is the combination of rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone (R-CHOP).

While the disease is generally responsive to treatment in the front line, Roche reports that as many as 40% of people will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short.

The committee’s recommendation for the combination is supported by data from the phase 3 POLARIX study, which demonstrated a statistically significant and clinically meaningful improvement in progression-free survival with Polivy plus R-CHP compared to standard of care R-CHOP in first line DLBCL.

The risk of disease progression, relapse or death was reduced by 27% with Polivy plus R-CHP compared with R-CHOP, the company reported, and the safety profile was comparable between both therapies.

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

“We believe the clinical benefit demonstrated in the POLARIX study may improve outcomes for many people with newly diagnosed DLBCL and look forward to continued collaboration with the FDA to make this treatment option available in the US.”

More than 60 countries have already approved this Polivy combination for the treatment of adult patients with previously untreated DLBCL, including in the EU, UK, Japan, Canada and China.

The FDA will now consider the panel’s advice as it works towards completing its review of the combination for this indication, with a decision expected in April this year.

Article by
Emily Kimber

14th March 2023

From: Regulatory



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