{"id":47316,"date":"2022-08-16T07:01:53","date_gmt":"2022-08-16T05:01:53","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/fda-accepts-supplemental-biologics-license-application-for-genentechs-polivy-combination-for-people-with-previously-untreated-diffuse-large-b-cell-lymphoma\/"},"modified":"2022-08-16T07:01:53","modified_gmt":"2022-08-16T05:01:53","slug":"fda-accepts-supplemental-biologics-license-application-for-genentechs-polivy-combination-for-people-with-previously-untreated-diffuse-large-b-cell-lymphoma","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/fda-accepts-supplemental-biologics-license-application-for-genentechs-polivy-combination-for-people-with-previously-untreated-diffuse-large-b-cell-lymphoma\/","title":{"rendered":"FDA Accepts Supplemental Biologics License Application for Genentech’s Polivy Combination for People With Previously Untreated Diffuse Large B-Cell Lymphoma"},"content":{"rendered":"
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\n\u2013 First new treatment regimen in more than 20 years to significantly improve outcomes in people with this fast-growing type of lymphoma \u2013<\/i>\n<\/p>\n

\n\u2013 Application is based on pivotal data from the Phase III POLARIX study showing Polivy plus R-CHP significantly reduced the risk of disease progression, relapse or death <\/i>with comparable safety <\/i>versus the standard of care, R-CHOP \u2013<\/i>\n<\/p>\n

\n\u2013 Various combination studies with Polivy and the company<\/i>\u2019<\/i>s CD20xCD3 bispecifics in diffuse large B-cell lymphoma are ongoing \u2013<\/i>\n<\/p>\n

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company\u2019s supplemental Biologics License Application (sBLA) for Polivy\u00ae<\/sup> (polatuzumab vedotin-piiq) in combination with Rituxan\u00ae<\/sup> (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of people with previously untreated diffuse large B-cell lymphoma (DLBCL). The FDA is expected to make a decision on approval by April 2, 2023.\n<\/p>\n

<\/a><\/p>\n

\n\u201cThe POLARIX study results suggest that Polivy plus R-CHP could transform the treatment of this aggressive malignancy, and we are working with the FDA to bring this combination to newly diagnosed DLBCL patients as soon as possible,\u201d said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. \u201cWe hope it will become the new standard of care for the first-line treatment of DLBCL, potentially reducing the need for subsequent treatments and limiting patient burden.\u201d\n<\/p>\n

\nDLBCL is an aggressive blood cancer. Although DLBCL often responds to initial treatment, it is not cured with the current standard of care in four out of 10 people. Most relapses occur within two years of starting treatment, and the majority of those who require subsequent lines of therapy have poor outcomes.\n<\/p>\n

\nThe sBLA is based on results from the pivotal Phase III POLARIX trial, which is the first in two decades to show a clinically meaningful improvement in progression-free survival (PFS) compared to the current standard of care Rituxan plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP). The risk of disease progression, relapse or death was reduced by 27% with Polivy plus R-CHP compared with R-CHOP after a median follow-up of 28.2 months (hazard ratio [HR] 0.73; 95% confidence interval [CI]: 0.57\u20130.95; p<0.02). Safety outcomes were consistent with those seen in previous clinical trials, and the safety profile was comparable for Polivy plus R-CHP versus R-CHOP, including rates of Grade 3-4 adverse events (AEs; 57.7% versus 57.5%), serious AEs (34.0% versus 30.6%), Grade 5 AEs (3.0% versus 2.3%), and AEs leading to dose reduction (9.2% versus 13.0%).\n<\/p>\n

\nBased on pivotal data from the POLARIX study, the European Commission approved Polivy in combination with R-CHP in May 2022 for the treatment of adult patients with previously untreated DLBCL. Polivy is currently approved as a readily available, fixed-duration treatment option for relapsed or refractory (R\/R) DLBCL in combination with bendamustine and Rituxan\/Mabthera in more than 70 countries worldwide, including in the United States and in the EU.\n<\/p>\n

\nGenentech continues to explore areas of unmet need where Polivy has the potential to deliver additional benefit, including in ongoing studies investigating combinations of Polivy with the company\u2019s CD20xCD3 T-cell engaging bispecific antibodies mosunetuzumab and glofitamab, and with Rituxan in combination with gemcitabine and oxaliplatin in the Phase III POLARGO study.\n<\/p>\n

\nAbout the POLARIX Study<\/b>\n<\/p>\n

\nPOLARIX [NCT03274492<\/a>] is an international Phase III, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety and pharmacokinetics of Polivy\u00ae<\/sup> (polatuzumab vedotin-piiq) plus Rituxan\u00ae<\/sup> (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) versus rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) in people with previously untreated diffuse large B-cell lymphoma (DLBCL). Eight-hundred and seventy-nine patients were randomized 1:1 to receive either Polivy plus R-CHP plus a vincristine placebo for six cycles, followed by rituximab for two cycles; or R-CHOP plus a Polivy placebo for six cycles, followed by two cycles of rituximab. The primary outcome measure is progression-free survival (PFS) as assessed by the investigator using the Lugano Response Criteria for malignant lymphoma. POLARIX is being conducted in collaboration with The Lymphoma Study Association (LYSA) and The Lymphoma Academic Research Organisation (LYSARC). Other clinical investigators from around the world also participated in the trial.\n<\/p>\n

\nAbout Diffuse Large B-cell Lymphoma<\/b>\n<\/p>\n

\nDiffuse large B-cell lymphoma (DLBCL) is the most common form of non-Hodgkin\u2019s lymphoma (NHL), accounting for about one in three cases of NHL. DLBCL is an aggressive (fast-growing) type of NHL. While it is generally responsive to treatment in the frontline, as many as 40% of people will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short. Approximately 150,000 people worldwide are estimated to be diagnosed with DLBCL each year.\n<\/p>\n

\nAbout Polivy\u00ae<\/sup> (polatuzumab vedotin-piiq)<\/b>\n<\/p>\n

\nPolivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). The CD79b protein is expressed specifically in the majority of B cells, an immune cell impacted in some types of non-Hodgkin\u2019s lymphoma (NHL), making it a promising target for the development of new therapies. Polivy binds to cancer cells such as CD79b and destroys these B cells through the delivery of an anti-cancer agent, which is thought to minimize the effects on normal cells. Polivy is being developed by Genentech using Seagen ADC technology and is currently being investigated for the treatment of several types of NHL.\n<\/p>\n

\nPolivy U.S. Indication<\/b>\n<\/p>\n

\nPolivy is a prescription medicine used with other medicines, bendamustine and a rituximab product, to treat diffuse large B-cell lymphoma in adults who have progressed after at least two prior therapies.\n<\/p>\n

\nThe accelerated approval of Polivy is based on a type of response rate. There are ongoing studies to confirm the clinical benefit of Polivy.\n<\/p>\n

\nImportant Safety Information<\/b>\n<\/p>\n

\nPossible serious side effects<\/b>\n<\/p>\n

\nEveryone reacts differently to Polivy therapy, so it\u2019s important to know what the side effects are. Some people who have been treated with Polivy have experienced serious to fatal side effects. <\/b>A patient\u2019s doctor may stop or adjust a patient\u2019s treatment if any serious side effects occur. Patients must contact their healthcare team if there are any signs of these side effects.<\/b>\n<\/p>\n