GENE ONLINE|News &
Opinion
Blog

.

Зеркало официального сайта всегда доступно для входа на Мостбет, даже при ограничениях. Скачать Mostbet – это шаг к удобству и азартным развлечениям.

Если вы ищете место для увлекательных ставок, обратите внимание на Joycasino, где лучшие предложения для игроков ждут вас.
2022-11-27| Trials & Approvals

Canada Authorizes Roche’s Polivy as First-Line Lymphoma Treatment

by Reed Slater
Share To

After success in the clinic and on the market as a second-line treatment, Health Canada authorized Roche’s CD79b-targeting antibody-drug conjugate, Polivy, as a first-line treatment for patients with untreated large B-cell lymphoma (LBCL), including diffuse LBCL (DLBCL). Genentech, a Roche subsidiary, is eyeing the same approval in the American market after the FDA accepted its supplemental biologics license application (BLA) in August this year. 

A New First-Line Treatment for Lymphoma Patients

LBCL is the most common type of lymphoma, a blood cancer that develops in the lymphatic system, which works with other parts of the immune system to help fight off infections and disease. As many as 40% of LBCL patients experience relapse within 24 months of initial treatment, so Roche says that an additional first-line treatment option may reduce the need for later-line treatments. 

Roche designed Polivy to target CD79b, a cell surface component of B-cell receptors. Once it binds to the cell surface, CD79b rapidly internalizes, helping deliver monomethyl auristatin E (MMAE), which works to kill dividing cells. 

Health Canada authorized Polivy based on the POLARIX Phase 3 clinical trial, which compared Polivy in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone to standard-of-care (R-CHOP) treatments. The trial included 879 participants with untreated LBCL; the primary endpoint was investigator-assessed progression-free survival. Participants who received Polivy experienced a 27% reduction in relapse or death compared to R-CHOP.

Dr. Laurie Sehn, Chair of the Lymphoma Tumor Group at the BC Cancer Centre for Lymphoid Cancer and Clinical Professor of Medicine in the Division of Medical Oncology at the University of British Columbia, spoke about the challenges of the initial management of LBCL. She said, “The POLARIX trial demonstrates a meaningful improvement in progression-free survival with the addition of polatuzumab vedotin and represents important progress in frontline therapy.”

Related Article: Astellas’ Claudin 18.2 Antibody Shows Its Teeth In GEJ Cancer Trial

The Quest to Carry Momentum into the American Market

The Canadian authorization came just a few months after the FDA accepted Genentech’s supplemental BLA for Polivy as a first-line treatment. If all goes well for the Roche subsidiary, the FDA could administer a decision by April 2, 2023.

Genentech will use the same POLARIX Phase 3 trial as the basis for the supplemental BLA, which Canadian authorities found sufficient for the same indication. Roche and Genentech say that the POLARIX trial is the first in two decades to show a clinically meaningful improvement in progression-free survival in LBCL patients. 

The FDA granted Polivy accelerated approval as a second-line LBCL treatment in June 2019. Accelerated approval requires confirmatory trials for full approval and additional indications, which Genentech and Roche have been working hard at to prove the drug’s worth in the lymphoma treatment market. 

Health Canada’s Polivy authorization is a sign of good things to come for the drug, which Roche and Genentech hope will become a new standard-of-care treatment for LBCL. Hopefully, by April of next year, the FDA will render its decision on whether or not it thinks Polivy is an acceptable first-line lymphoma treatment for the American market. 

©www.geneonline.com All rights reserved. Collaborate with us: [email protected]
Related Post
Roche’s STI Test Clears FDA Potentially Becoming A Game-Changer for Fast, Accurate Diagnosis
2025-01-23
China’s Innovent Biologics Secures USD $1 Billion ADC Oncology Licensing Agreement with Roche
2025-01-06
The Boldest Business Matchmaking of 2024: A Look at the Top M&A Activity
2025-01-02
LATEST
Novo Nordisk Bets Big on CagriSema With A Heavyweight Move Planned for 2026
2025-02-07
Major Win – FDA Grants Fast Track Designation to Adicet Bio’s ADI-001 for Lupus Disease
2025-02-07
First-of-its-Kind Diagnostic Aid Uses a Single Hair Strand to Detect Autism Risk in Babies
2025-02-06
Teladoc Dials Up Virtual Care with $70 Million Acquisition of Catapult
2025-02-06
Silicon Valley in the Crosshairs as EU Readies to Strike U.S. Big Tech
2025-02-06
Johnson & Johnson Under Fire Again as Legal Action Over Alleged Talc-Cancer Link Moves to the UK
2025-02-05
MediBuddy Partners with Japan’s ELECOM to Launch Smart Health IoT Devices in India
2025-02-05
EVENT
2025-02-05
Precision Medicine World Conference 2025
Santa Clara, California
2025-02-19
Healthcare Conference Taipei 2025
Taipei, Taiwan
2025-03-17
BIO-Europe Spring 2025
Milan, Italy
2025-04-21
World Vaccine Congress 2025
Washington, U.S.A
2025-04-25
AACR Annual Meeting 2025
Chicago, U.S.A
Scroll to Top