{"id":56020,"date":"2023-04-19T22:03:03","date_gmt":"2023-04-19T20:03:03","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/fda-approves-genentechs-polivy-in-combination-with-r-chp-for-people-with-certain-types-of-previously-untreated-diffuse-large-b-cell-lymphoma\/"},"modified":"2023-04-19T22:03:03","modified_gmt":"2023-04-19T20:03:03","slug":"fda-approves-genentechs-polivy-in-combination-with-r-chp-for-people-with-certain-types-of-previously-untreated-diffuse-large-b-cell-lymphoma","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/fda-approves-genentechs-polivy-in-combination-with-r-chp-for-people-with-certain-types-of-previously-untreated-diffuse-large-b-cell-lymphoma\/","title":{"rendered":"FDA Approves Genentech\u2019s Polivy in Combination With R-CHP for People With Certain Types of Previously Untreated Diffuse Large B-cell Lymphoma"},"content":{"rendered":"
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\n\u2013 Polivy combination is the first FDA-approved therapy in nearly 20 years for the first-line treatment of diffuse large B-cell lymphoma, an aggressive disease and the most common form of non-Hodgkin\u2019s lymphoma in the U.S. \u2013<\/i><\/p>\n

\n\u2013 POLARIX trial showed the Polivy combination reduced the risk of disease progression, relapse or death by 27% compared to the standard of care, R-CHOP, with a comparable safety profile \u2013<\/i><\/p>\n

\n\u2013 First-line treatment with Polivy plus R-CHP has the potential to reduce the burden on patients and healthcare systems, associated with disease progression \u2013<\/i><\/p>\n

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Polivy\u00ae<\/sup> (polatuzumab vedotin-piiq) in combination with Rituxan\u00ae<\/sup> (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index (IPI) score of two or greater. This FDA decision converts the accelerated approval of Polivy in combination with bendamustine and Rituxan for relapsed or refractory (R\/R) DLBCL after at least two prior therapies to regular approval.<\/p>\n

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

\nDLBCL is an aggressive, hard-to-treat disease and is the most common form of non-Hodgkin\u2019s lymphoma in the United States. Approximately 31,000 people in the U.S. are projected to be diagnosed with DLBCL in 2023. Limited progress has been made in improving patient outcomes in previously untreated DLBCL over the last two decades. While many patients are responsive to initial treatment, as many as four in 10 people with DLBCL do not respond or relapse. For people who undergo initial treatment with the standard of care, Rituxan plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP), most relapses occur within two years of starting treatment, and the majority of those who require subsequent lines of therapy have poor outcomes.<\/p>\n

\n\u201cIt has been nearly 20 years since a new treatment option has become available to people newly diagnosed with diffuse large B-cell lymphoma,\u201d said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. \u201cToday\u2019s decision from the FDA to approve Polivy in combination with R-CHP in this setting brings a much-needed new treatment option which may improve outcomes and bring other benefits to many patients with this aggressive lymphoma.\u201d<\/p>\n

\nThe FDA approval of Polivy plus R-CHP for the first-line treatment of DLBCL is based on pivotal data from POLARIX, an international Phase III, randomized, double-blind, placebo-controlled study that demonstrated a statistically significant and clinically meaningful improvement in PFS compared to R-CHOP. The risk of disease progression, relapse or death was reduced by 27% with Polivy plus R-CHP (n=440) compared with R-CHOP (n=439; hazard ratio [HR] 0.73; 95% confidence interval [CI]: 0.57\u20130.95; p<0.02). 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%). The most common AEs were peripheral neuropathy, nausea, fatigue, diarrhea, constipation, alopecia, and mucositis. The most common Grade 3-4 AEs were lymphopenia and neutropenia.<\/p>\n

\nThis approval follows the FDA Oncologic Drugs Advisory Committee (ODAC) vote of 11 to 2 in favor of Polivy in combination with R-CHP for previously untreated DLBCL. More than 70 countries have approved this Polivy combination for the treatment of adult patients with previously untreated DLBCL, including in the EU, UK, Japan, Canada and China. Polivy in combination with R-CHP was recently added to the National Comprehensive Cancer Network\u00ae<\/sup> (NCCN\u00ae<\/sup>) Clinical Practice Guidelines in Oncology (NCCN Guidelines\u00ae<\/sup>) as a category 1, preferred regimen for first-line DLBCL. Polivy in combination with bendamustine and Rituxan is currently approved in more than 80 countries worldwide for the treatment of adults with relapsed or refractory (R\/R) DLBCL after one or more prior therapies, including in the U.S.<\/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 Lunsumio\u00ae<\/sup> (mosunetuzumab-axgb) or glofitamab. Trials include the Phase III SUNMO study in combination with Lunsumio in patients with R\/R DLBCL and the Phase III POLARGO study with Rituxan in combination with gemcitabine and oxaliplatin in patients with R\/R DLBCL.<\/p>\n

\nGenentech is committed to helping people access the medicines they are prescribed and offers comprehensive services for people prescribed Polivy to help minimize barriers to access and reimbursement. For people who qualify, Genentech offers patient assistance programs through Genentech Access Solutions. More information is also available at 866-4ACCESS\/866-422-2377 or http:\/\/www.Genentech-Access.com<\/a>.<\/p>\n

\nAbout the POLARIX Study<\/b><\/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 Rituxan, 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 Rituxan for two cycles; or R-CHOP plus a Polivy placebo for six cycles, followed by two cycles of Rituxan. The primary outcome measure is progression-free survival 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).<\/p>\n

\nAbout Diffuse Large B-Cell Lymphoma<\/b><\/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 160,000 people worldwide are estimated to be diagnosed with DLBCL each year.<\/p>\n

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

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

\nPOLIVY is a prescription medicine used with other medicines (a rituximab product, cyclophosphamide, doxorubicin, and prednisone) as a first treatment for adults who have moderate to high risk diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL).<\/p>\n

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

\nPossible serious side effects<\/b><\/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>Your doctor may stop or adjust your treatment if any serious side effects occur. Be sure to contact your healthcare team if there are any signs of these side effects.<\/b><\/p>\n