USA — After a recent regulatory scare, Roche has received approval from the FDA to begin work on changing the standard of care for diffuse large B-cell lymphoma (DLBCL), which has remained relatively unchanged for almost 20 years.

Roche announced on Wednesday that its drug Polivy has been approved as part of a five-drug combination for the treatment of previously untreated DLBCL or high-grade B-cell lymphoma.

Roche claims that this new treatment regimen is the first in almost two decades to significantly improve outcomes in first-line DLBCL.

Industry analysts have speculated that front-line use could increase Polivy’s peak sales by as much as US$2 billion.

However, it is still unclear to what extent Polivy will be able to challenge the standard R-CHOP therapy, given that the FDA has previously expressed reservations about the company’s application.

The regulatory approval for Polivy was based on the results of the phase 3 POLARIX trial, which demonstrated that Polivy and R-CHP reduced the risk of progression or death by 27% compared to R-CHOP.

Roche is replacing the Oncovin (O) component in R-CHOP with Polivy, an antibody-drug conjugate, to develop this new regimen.

While Roche’s Polivy approval represents an exciting development in the treatment of DLBCL, some experts have noted that there is still a need for further research and trials to determine its long-term efficacy and safety.

Following the approval of Roche’s drug Polivy for the treatment of diffuse large B-cell lymphoma (DLBCL), there have been mixed reactions from members of the FDA advisory committee.

Some experts believe that the POLARIX results, which served as the basis for the approval, may not represent a significant breakthrough in the treatment of the disease.

However, Roche has received support for the adoption of Polivy from the National Comprehensive Cancer Network, which has included the drug as a preferred regimen for first-line DLBCL.

This endorsement comes at the highest level of category 1 and provides Roche with a significant tailwind for adoption.

In addition to the approval for first-line DLBCL, the FDA has also converted the accelerated approval for Polivy, which was previously granted in combination with Rituxan and bendamustine as a third-line treatment for DLBCL, into full approval.

Roche remains committed to improving treatment outcomes for DLBCL and is now turning its attention to a phase 3 SUNMO study.

In this study, Polivy will be combined with Roche’s CD20xCD3 bispecific antibody Lunsumio to evaluate its efficacy in previously treated disease.

While there has been some skepticism regarding the significance of the POLARIX results, it is important to note that Polivy represents an important advancement in the treatment of DLBCL.

With the endorsement from the National Comprehensive Cancer Network and the conversion of its accelerated approval into full approval, Roche is poised to make significant progress in improving the standard of care for DLBCL patients.

The SUNMO study represents a crucial step forward in this ongoing effort to develop innovative new treatments for this devastating disease.

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