The United States Food and Drug Administration (FDA) has accepted the supplemental biologics license application(sBLA) by Roche, a Swiss multinational healthcare company, for the treatment of long untreated diffuse large B-cell lymphoma (DLBCL).
Roche said the FDA had accepted its sBLA to use Polivy (polatuzumab vedotin-piiq) in conjunction with rituxan, cyclophosphamide, doxorubicin, and prednisone (R-CHP). The l company intends to use this to treat DLBCL in patients who had not been treated earlier.
The sBLA is a result of the Polarix Phase III trial. The FDA’s decision is awaited and expected to be announced around 2 April 2023.
Diffuse large B-cell lymphoma is a common type of non-Hodgkin lymphoma or cancer. While patients are generally responsive, around 40 percent of people tend to relapse or have refractory disease. DLBCL is a hostile type of blood cancer. People affected by this tend to relapse within a span of about two years of commencing treatment, as commonly observed.
What is the Polarix Phase III trial?
Polarix is a study conducted by The Lymphoma Academic Research Organization (LYSARC) in association with The Lymphoma Study Association (LYSA). This is a randomized clinical trial involving patients with untreated DLBCL.
In Phase III, an international, double-blind, placebo-controlled study was conducted. Pola-R-CHP with R-CHOP in patients is compared with previously untreated DLBCL.
The sBLA relies on results that showed PFS’s (progression-free survival) improvement with respect to the existing care standard for Rituxan plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP).
With Polivy plus R-CHP, a 27 percent decline was observed in the risk of the progress of relapse, DLBCL, or death than R-CHOP post a median follow-up of 28.2 months.
Levi Garraway, Roche’s chief medical officer, informed FDA News that the results of the Polarix study indicate that the malignancy of DLBCL can be treated. It implies that the Polivy plus R-CHP can completely change the treatment, reducing the need for subsequent treatment.
Roche is working with the FDA to bring this combination to those diagnosed with DLBCL for the first time. The aim is to make it the standard treatment for future DLBCL cases.