{"id":26152,"date":"2020-07-02T07:18:00","date_gmt":"2020-07-02T07:18:00","guid":{"rendered":"http:\/\/5154702b09d26df3ef1355b1c616a5d7"},"modified":"2024-11-03T15:16:45","modified_gmt":"2024-11-03T15:16:45","slug":"fda-approves-combination-of-pertuzumab-trastuzumab-and-hyaluronidase-zzxf-for-her2-positive-breast-cancer","status":"publish","type":"post","link":"https:\/\/ogkologos.com\/en\/fda-approves-combination-of-pertuzumab-trastuzumab-and-hyaluronidase-zzxf-for-her2-positive-breast-cancer\/","title":{"rendered":"FDA Approves Combination of Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf for HER2-positive Breast Cancer"},"content":{"rendered":"<p>On 29 June 2020, the US Food and Drug Administration (FDA) approved a new fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase\u2013zzxf<br \/>(PHESGO, Genentech, Inc.) for subcutaneous injection for the following indications:&nbsp;<\/p>\n<ul>\n<li>Use in combination with chemotherapy as:&nbsp;\n<ul>\n<li>neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer;<\/li>\n<li>adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence.<\/li>\n<\/ul>\n<\/li>\n<li>Use in combination with docetaxel for treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.<\/li>\n<\/ul>\n<p>Efficacy was investigated in FeDeriCa (NCT03493854), an open-label, multicentre, randomised trial enrolling 500 patients with operable or locally advanced HER2-positive breast cancer. Patients were randomised to receive neoadjuvant chemotherapy with concurrent administration of either PHESGO or intravenous pertuzumab and intravenous trastuzumab during the neoadjuvant and adjuvant therapies.<\/p>\n<p>The primary endpoint of FeDeriCa was non-inferiority of cycle 7 pertuzumab serum trough concentration comparing PHESGO to intravenous pertuzumab. Secondary endpoints included cycle 7 trastuzumab serum trough concentration, pathological complete response (pCR), and safety. PHESGO showed non-inferior pertuzumab and trastuzumab serum trough concentrations compared to intravenous pertuzumab and trastuzumab. The pCR rate was 59.7% (95% confidence interval [CI] 53.3, 65.8) in the PHESGO arm and 59.5% (95% CI 53.2, 65.6) in the intravenous pertuzumab and intravenous trastuzumab arm.&nbsp; The safety profile of PHESGO is comparable to intravenous pertuzumab and trastuzumab, except for increased administration-related reactions.<\/p>\n<p>The most common adverse reactions in &gt;30% patients receiving PHESGO were alopecia, nausea, diarrhoea, anaemia, and asthenia.<\/p>\n<p>The recommended initial dose of PHESGO is 1,200 mg pertuzumab, 600 mg trastuzumab, and 30,000 units hyaluronidase administered subcutaneously over approximately 8 minutes, followed every 3 weeks by a dose of 600 mg pertuzumab,<br \/>600 mg trastuzumab, and 20,000 units hyaluronidase administered subcutaneously over approximately 5 minutes.<\/p>\n<p>Full prescribing information for PHESGO is available <a href=\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/761170s000lbl.pdf\" target=\"_blank\" rel=\"nofollow noopener noreferrer\" class=\"external-link\">here<\/a>.<\/p>\n<p>This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA\u2019s assessment. This application was approved 4 months prior to the FDA goal date.<\/p>\n<p>Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA\u2019s MedWatch Reporting System.<\/p>\n<p>For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact FDA\u2019s <a href=\"https:\/\/www.fda.gov\/about-fda\/fda-organization\/oncology-center-excellence\" target=\"_blank\" rel=\"nofollow noopener noreferrer\" class=\"external-link\">Oncology Center of Excellence<\/a>&nbsp;<a href=\"https:\/\/www.fda.gov\/about-fda\/oncology-center-excellence\/project-facilitate\" target=\"_blank\" rel=\"nofollow noopener noreferrer\" class=\"external-link\">Project Facilitate<\/a>.<\/p>\n<p><a href=\"http:\/\/www.esmo.org\/oncology-news\/fda-approves-combination-of-pertuzumab-trastuzumab-and-hyaluronidase-zzxf-for-her2-positive-breast-cancer\">Source<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On 29 June 2020, the US Food and Drug Administration (FDA) approved a new fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase\u2013zzxf(PHESGO, Genentech, Inc.) for subcutaneous injection for the following indications:&nbsp; Use in combination with chemotherapy as:&nbsp; neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"footnotes":""},"categories":[5137],"tags":[],"class_list":["post-26152","post","type-post","status-publish","format-standard","hentry","category-world-news"],"_links":{"self":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/26152","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/comments?post=26152"}],"version-history":[{"count":1,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/26152\/revisions"}],"predecessor-version":[{"id":44246,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/posts\/26152\/revisions\/44246"}],"wp:attachment":[{"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/media?parent=26152"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/categories?post=26152"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ogkologos.com\/en\/wp-json\/wp\/v2\/tags?post=26152"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}