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▎WuXi AppTec content team editor Roche (Roche) today announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended approval of the antibody drug conjugate (ADC) Polivy (polatuzumab vedotin) and the treatment called R-CHP The combination of regimens is used in the first-line treatment of patients with diffuse large B-cell lymphoma (DLBCL)
.
The release notes that the combination of Polivy with R-CHP is the first treatment in more than 20 years to significantly improve outcomes for this disease
.
DLBCL is the most common type of non-Hodgkin lymphoma (NHL), accounting for about one-third of NHLs
.
DLBCL is an aggressive type of NHL, and approximately 150,000 people are diagnosed with DLBCL every year worldwide
.
While first-line therapy is often effective, up to 40% of patients will relapse or develop refractory disease, where treatment options are limited, survival is short, and there is an unmet medical need
.
The CD79b protein is specifically expressed in most B cells, making it a promising target for the development of new therapies
.
By specifically binding to CD79b on tumor cells, Polivy delivers anticancer drugs to kill these B cells and minimize damage to normal cells
.
At present, Polivy is approved in more than 60 countries and regions around the world, and is used in combination with bendamustine or rituximab (rituximab, the English brand name is Rituxan) for the treatment of relapsed or refractory (R/R ) DLBCL patients
.
The positive CHMP opinion is based on efficacy and safety data from a Phase 3 clinical trial
.
The trial results showed that the Polivy combination therapy significantly improved the progression-free survival of patients compared with the standard treatment of birituximab + cyclophosphamide + doxorubicin + vincristine + prednisone (R-CHOP).
HR=0.
73; 95% CI: 0.
57-0.
95; P<0.
02)
.
The clinical trial results have been published in the New England Journal of Medicine
.
"A large proportion of patients with DLBCL do not respond adequately to existing therapies
, " said Dr.
Levi Garraway
, chief medical officer and head of global product development at Roche
.
A Polivy combination to bring DLBCL patients as soon as possible
.
"Reference: [1] CHMP recommends EU approval of Roche's Polivy combination for people with previously untreated diffuse large B-cell lymphoma.
Retrieved March 25, 2022, from https:// .
com/media/releases/med-cor-2022-03-25b[2] Tilly et al.
, (2021).
Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma.
NEJM, DOI: 10.
1056/NEJMoa2115304 Disclaimer: The WuXi AppTec content team focuses on introducing global biomedical health research progress
.
This article is for information exchange purposes only.
The views expressed in this article do not represent WuXi AppTec's position, nor do they represent WuXi AppTec's support or opposition to the views expressed in the article.
.
This article is also not a treatment plan recommendation
.
For guidance on treatment options, please visit a regular hospital
.
.
The release notes that the combination of Polivy with R-CHP is the first treatment in more than 20 years to significantly improve outcomes for this disease
.
DLBCL is the most common type of non-Hodgkin lymphoma (NHL), accounting for about one-third of NHLs
.
DLBCL is an aggressive type of NHL, and approximately 150,000 people are diagnosed with DLBCL every year worldwide
.
While first-line therapy is often effective, up to 40% of patients will relapse or develop refractory disease, where treatment options are limited, survival is short, and there is an unmet medical need
.
The CD79b protein is specifically expressed in most B cells, making it a promising target for the development of new therapies
.
By specifically binding to CD79b on tumor cells, Polivy delivers anticancer drugs to kill these B cells and minimize damage to normal cells
.
At present, Polivy is approved in more than 60 countries and regions around the world, and is used in combination with bendamustine or rituximab (rituximab, the English brand name is Rituxan) for the treatment of relapsed or refractory (R/R ) DLBCL patients
.
The positive CHMP opinion is based on efficacy and safety data from a Phase 3 clinical trial
.
The trial results showed that the Polivy combination therapy significantly improved the progression-free survival of patients compared with the standard treatment of birituximab + cyclophosphamide + doxorubicin + vincristine + prednisone (R-CHOP).
HR=0.
73; 95% CI: 0.
57-0.
95; P<0.
02)
.
The clinical trial results have been published in the New England Journal of Medicine
.
"A large proportion of patients with DLBCL do not respond adequately to existing therapies
, " said Dr.
Levi Garraway
, chief medical officer and head of global product development at Roche
.
A Polivy combination to bring DLBCL patients as soon as possible
.
"Reference: [1] CHMP recommends EU approval of Roche's Polivy combination for people with previously untreated diffuse large B-cell lymphoma.
Retrieved March 25, 2022, from https:// .
com/media/releases/med-cor-2022-03-25b[2] Tilly et al.
, (2021).
Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma.
NEJM, DOI: 10.
1056/NEJMoa2115304 Disclaimer: The WuXi AppTec content team focuses on introducing global biomedical health research progress
.
This article is for information exchange purposes only.
The views expressed in this article do not represent WuXi AppTec's position, nor do they represent WuXi AppTec's support or opposition to the views expressed in the article.
.
This article is also not a treatment plan recommendation
.
For guidance on treatment options, please visit a regular hospital
.