FDA approves atezolizumab plus bevacizumab for unresectable hepatocellular carcinoma

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bevacizumab (TECENTRIQ and AVASTIN, Genentech Inc.) for patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.</p> <p>Efficacy was investigated in IMbrave150 (NCT03434379), a multicenter, international, open-label, randomized trial in patients with locally advanced unresectable or metastatic hepatocellular carcinoma who had not received prior systemic therapy. A total of 501 patients were randomized (2:1) to receive either atezolizumab 1200 mg as an intravenous infusion (IV) followed by bevacizumab 15 mg/kg IV on the same day, every 3 weeks, or sorafenib orally twice daily.</p> <p>The main efficacy outcome measures were overall survival (OS) and independent review facility (IRF)-assessed progression-free survival (PFS) per RECIST 1.1. Additional efficacy outcome measures were IRF-assessed overall response rate (ORR) per RECIST 1.1 and mRECIST.</p> <p>Median OS was not reached in the patients who received atezolizumab plus bevacizumab and was 13.2 months (95% CI: 10.4, NE) in the patients who received sorafenib (HR 0.58; 95% CI: 0.42, 0.79; p=0.0006). Estimated median PFS was 6.8 months (95% CI: 5.8, 8.3) vs. 4.3 months (95% CI: 4.0, 5.6), respectively (HR  0.59; 95% CI: 0.47, 0.76; p<0.0001). The ORR per RECIST 1.1 was 28% (95% CI: 23, 33) in the atezolizumab plus bevacizumab group compared with 12% (95% CI: 7,17) in the sorafenib group (p<0.0001). The ORR per mRECIST was 33% (95% CI: 28, 39) vs. 13% (95% CI: 8, 19), respectively (p<0.0001).</p> <p>The most common adverse reactions (reported in ≥20% of patients) with atezolizumab plus bevacizumab in patients with HCC were hypertension, fatigue and proteinuria.</p> <p>The recommended atezolizumab dose is 1,200 mg, followed by 15 mg/kg bevacizumab on the same day every 3 weeks. If bevacizumab is discontinued, atezolizumab should be given either as 840 mg every 2 weeks, 1,200 mg every 3 weeks, or 1,680 mg every 4 weeks.</p> <p><a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761034s025lbl.pdf">View full prescribing information for TECENTRIQ</a>.<br> <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125085s332lbl.pdf">View full prescribing information for AVASTIN</a>.</p> <p>FDA collaborated with the Australian Therapeutic Goods Administration (TGA), Health Canada, and Singapore’s Health Sciences Authority (HSA) on the review of the atezolizumab application as part of <a href="/about-fda/oncology-center-excellence/project-orbis">Project Orbis</a>. FDA approved this application nearly two months ahead of schedule. The review of the atezolizumab application is ongoing for the Australian TGA, Health Canada and Singapore’s HSA.</p> <p>This review used the <a href="/about-fda/oncology-center-excellence/real-time-oncology-review-pilot-program">Real-Time Oncology Review</a> (RTOR), which streamlined data submission prior to the filing of the entire clinical application, and the <a href="/about-fda/oncology-center-excellence/assessment-aid">Assessment Aid</a>, a voluntary submission from the applicant to facilitate the FDA’s assessment.</p> <p>These applications were granted priority review and atezolizumab and bevacizumab received breakthrough designation. A description of FDA expedited programs is in the <a href="/regulatory-information/search-fda-guidance-documents/expedited-programs-serious-conditions-drugs-and-biologics">Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics</a>.</p> <p>Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s <a href="https://www.accessdata.fda.gov/scripts/medwatch/index.cfm">MedWatch Reporting System</a> or by calling 1-800-FDA-1088.</p> <p>For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s <a href="/about-fda/oncology-center-excellence/project-facilitate">Project Facilitate</a> at 240-402-0004 or email <a href="mailto:OncProjectFacilitate@fda.hhs.gov">OncProjectFacilitate@fda.hhs.gov</a>.</p> <p>For information on the COVID-19 pandemic, see the following resources:</p> <ul> <li><a href="/emergency-preparedness-and-response/mcm-issues/coronavirus-disease-2019-covid-19">FDA: Coronavirus Disease 2019 (COVID-19)</a></li> <li><a href="https://www.cancer.gov/contact/emergency-preparedness/coronavirus">NCI: Coronavirus: What People With Cancer Should Know</a></li> <li><a href="https://www.cdc.gov/coronavirus/2019-ncov/index.html">CDC: Coronavirus (COVID-19)</a></li> </ul> <p>Follow the <a href="/OCE">Oncology Center of Excellence</a> on Twitter <a href="http://www.twitter.com/@fdaoncology">@FDAOncology</a>.</p> <p> </p>   </div> <aside class="col-md-2 col-md-push-2" role="complementary"> <section id="block-entityviewcontent-4" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <aside class="lcds-card lcds-card--border-top"> <ul role="menu" class="lcds-description-list"> <li role="menuitem" class="node-current-date lcds-description-list__item"> <div> <h2 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FDA approves atezolizumab plus bevacizumab for unresectable hepatocellular carcinoma | FDA