Roche's First-in-Class Anti-CD79b ADC Polatuzumab Vedotin Submitted for Marketing Approval in China

Source: PharmaCube Info

On December 2, the CDE website showed that Roche's Polatuzumab vedotin for injection had its marketing application accepted by the National Medical Products Administration (NMPA). This is the first anti-CD79b antibody-drug conjugate (ADC) to be submitted for marketing in China.

Polivy is a first-in-class anti-CD79b ADC. The CD79b protein is specifically expressed in most B cells, and Polivy can specifically bind to the CD79b protein and release chemotherapeutic drugs to destroy B cells, minimizing the impact on normal cells.

Mechanism of Action of Vaborbactam

Polivy (Pivotal Drug: Polatuzumab Vedotin) was first approved by the FDA in June 2019 for use in combination with Bendamustine and Rituxan (Rituximab) to treat adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received at least two prior therapies.

A Phase Ib/II clinical trial evaluated the efficacy of Polivy in 80 patients with relapsed or refractory DLBCL. Participants were randomly assigned to receive either standard therapy with bendamustine plus rituximab or Polivy in combination with bendamustine and rituximab. Results showed a complete response rate of 18% in the standard therapy group compared to 40% in the Polivy group. Additionally, among patients achieving partial or complete responses in the Polivy group, 64% had a duration of response lasting more than six months, with 48% lasting over a year.

Notably, in August this year, the pivotal Phase III POLARIX trial of Polivy in combination with R-CHP as a first-line treatment for DLBCL met its primary endpoint. The study results showed that Polivy+R-CHP significantly improved PFS compared to the R-CHOP regimen. Polivy+R-CHP is the first treatment regimen in 20 years to significantly improve outcomes for such patients compared to the standard of care.