FDA Approves Roche’s Polivy as the First-Line Treatment for Diffuse Large B-Cell Lymphoma

Roche-subsidiary Genentech’s groundbreaking Polivy (polatuzumab vedotin-piiq) has been given the green light by the FDA, as part of a five-drug regimen, to treat patients with diffuse large B-cell lymphoma (DLBCL) as a first-line treatment.

Combining Polivy with Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP), this treatment regimen is a promising step forward for those with high-grade B-cell lymphoma with an International Prognostic Index score of at least two.

Thursday marked a major milestone in healthcare as Roche announced the approval of a new therapeutic option for patients with newly diagnosed DLBCL, the first of its kind in nearly two decades. Levi Garraway, Roche’s Chief Medical Officer and Global Product Development Head, described the win as an “exciting development” for those affected.

The FDA’s decision to grant regular approval to Polivy as a combination regimen with Rituxan and Bendamustine in relapsed or refractory DLBCL marks a major milestone for the drug. Initially granted accelerated approval in June 2019, Polivy is now officially recognized as a safe and effective treatment for this difficult-to-treat cancer.

By employing the current standard of care, many cancer patients face the sobering reality of relapse after initial treatment. Charles Fuchs, Senior Vice President and Global Head, Oncology & Hematology Product Development, Genentech and Roche, is determined to change this statistic by providing an effective and tolerable therapy at the time of first diagnosis, to help delay disease progression and the need for subsequent treatments.

Genentech is exploring the potential of Polivy to treat not only blood cancers but also other types of cancers in combination with other therapies, according to Fuchs. This could open up new possibilities for fighting cancer and could be a game-changer in the field of oncology.

Polivy is an innovative antibody-drug conjugate that targets CD79b, a protein expressed on the surface of B cells. The drug was approved by the FDA following the successful completion of the Phase III randomized and double-blinded POLARIX study. This groundbreaking therapy offers a promising new treatment option for patients suffering from B cell-related illnesses.

A recent study found that a Polivy-based regimen significantly reduced the risk of disease progression, relapse or death by 27% compared to the standard-of-care regimen R-CHP plus vincristine. The study, which involved 879 patients, was a major breakthrough in the treatment of cancer.

The Polivy-based combination regimen proved to be just as safe as the standard of care, with grade 3/4 and grade 5 adverse events, serious side effects and toxicities leading to dose reductions being comparable between the two. Rest assured, this treatment is a safe and reliable option.

In March, the FDA’s independent Oncologic Drugs Advisory Committee gave Genentech their resounding support, voting 11–2 in favor of Polivy due to its impressive efficacy and safety profile. This vote of confidence endorses Polivy as a viable first-line intervention for this patient population, demonstrating its favorable risk-benefit profile.

The FDA’s briefing document released before the Committee meeting raised concerns about Polivy’s efficacy, despite the fact that POLARIX had demonstrated a statistically significant improvement in its primary endpoint of progression-free survival. While the treatment effect was found to be “modest” at 27%, FDA staffers questioned whether this could be deemed clinically meaningful.

The FDA raised concerns about Polivy’s ability to provide overall survival (OS) benefits, complete response, and even a limited effect on disease-free survival, event-free survival, and duration of response. Despite these worries, the FDA was still willing to approve the drug.

The Polivy regimen was found to reduce the risk of death by 6%, although the result was not statistically significant, after a median follow-up of 39.7 months. Initially, the standard of care seemed to offer better outcomes in terms of overall survival, but this changed as the data was collected over time.

The FDA’s briefing document reflects the lack of improvement in overall survival rates for frontline therapy of LBCL, adding to the already uncertain benefit-risk. Despite the low event rates, the associated uncertainties do not diminish the importance of safety and efficacy.

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