The FDA has started a review of Roche’s Polivy for people with previously untreated diffuse large B-cell lymphoma (DLBCL), as the drugmaker tries to move the drug further up the treatment pathway in the US.
Polivy (polatuzumab vedotin) – an antibody-drug conjugate targeting CD79b – was cleared by the European Commission for the new indication in May, building on its earlier approval as a third-line treatment for DLBCL alongside rituximab and bendamustine. An FDA decision is due by 2 April, 2023.
Roche has previously said that approval of the ADC for newly-diagnosed patients could unlock a market worth around $2 billion a year, transforming the commercial potential of the drug which made CHF 119 million in the first half of this year.
It says Polivy is the first therapy in more than 20 years to significantly improve outcomes in front-line therapy of DLBCL, a particularly aggressive form of blood cancer.
The filing is based on the results of the POLARIX study of Polivy given alongside a chemotherapy regimen known as RCH-P (rituximab plus cyclophosphamide, doxorubicin and prednisone).
The results showed that the combination reduced the risk of disease progression, relapse, or death by 27% compared to R-CHP alone after a median follow-up of 28 months.
Around 40% of people with DLBCL relapse after initial therapy, so boosting responses in the front-line setting has the potential to provide big benefits to patients, according to Roche’s chief medical officer Levi Garraway.
“We hope it will become the new standard of care for the first-line treatment of DLBCL, potentially reducing the need for subsequent treatments and limiting patient burden,” he said.
Polivy is also being developed in combination with Roche and AbbVie’s Venclexto/Venclyxto (venetoclax) in DLBCL and other forms of NHL, and alongside the Swiss drugmaker’s bispecific antibodies, including recently-approved follicular lymphoma therapy Lunsumio (mosunetuzumab) and experimental candidate glofitamab – in various blood cancers.
Another phase 3 trial – called POLARGO – is comparing Polivy, Rituxan and chemotherapy with gemcitabine and oxaliplatin to the Rituxan/chemo regimen as a second-line therapy for DLBCL.
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