Roche Submits NDA in China for First-in-Class Anti-CD79b ADC Polatuzumab Vedotin

Source: Medicinal Landscape

China's National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) announced on its official website that Roche has submitted four marketing applications in China for Polatuzumab Vedotin for Injection. Public information shows that Polatuzumab Vedotin is a "first-in-class" antibody-drug conjugate (ADC) targeting CD79b, which has been approved for marketing in more than 60 countries and regions worldwide to treat relapsed or refractory diffuse large B-cell lymphoma.

Screenshot source: CDE official website

CD79b Protein Is Specifically Expressed in Most B Cells, Making It a Promising Target for New Therapy Development. Polivy (Chinese generic name: Viberotuzumab) is an ADC targeting CD79b. By specifically binding to CD79b on tumor cells, it delivers anticancer drugs to kill these B cells while minimizing harm to normal cells.

In China, the CDE accepted four marketing applications for injectable obinutuzumab in December 2021. Notably, on December 21, the CDE granted obinutuzumab priority review status for the proposed treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Publicly available information shows that, globally, polatuzumab vedotin has been approved in more than 60 countries and regions. It is used in combination with bendamustine or rituximab to treat patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). According to the clinical data released when the drug was approved by the U.S. FDA, in treating patients with relapsed or refractory DLBCL, the complete response rate in the polatuzumab vedotin treatment group was 40%, compared to only 18% in the standard treatment group.

Notably, according to a recent press release from Roche, the combination of Viberzi and a regimen named R-CHP (rituximab + cyclophosphamide + doxorubicin + prednisone) has achieved positive results in a Phase 3 clinical trial for the first-line treatment of patients with diffuse large B-cell lymphoma. Compared with the current standard treatment R-CHOP (rituximab + cyclophosphamide + doxorubicin + vincristine + prednisone), the combination of Viberzi and R-CHP reduced the risk of disease progression or death by 27%.

DLBCL is the most common type of non-Hodgkin lymphoma (NHL), accounting for about one-third of NHL cases. DLBCL is an aggressive type of NHL, with approximately 150,000 people worldwide diagnosed with DLBCL each year.

Note: The original text has been abridged.

References:

[1] Center for Drug Evaluation, National Medical Products Administration of China. Retrieved Dec 30, 2021, from https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d

[2] Roche’s Polivy Combination Reduced The Risk Of Disease Worsening Or Death By 27% In People With Previously Untreated Aggressive Form Of Lymphoma. Retrieved December 14, 2021, from https://www.roche.com/media/releases/med-cor-2021-12-14.htm

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