{"id":807700,"date":"2025-02-03T07:35:09","date_gmt":"2025-02-03T12:35:09","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/chmp-issues-positive-opinion-for-subcutaneous-rybrevantamivantamab-co-formulated-with-enhanze-for-the-treatment-of-patients-with-advanced-egfr-mutated-non-small-cell-lung-cancer\/"},"modified":"2025-02-03T07:35:09","modified_gmt":"2025-02-03T12:35:09","slug":"chmp-issues-positive-opinion-for-subcutaneous-rybrevantamivantamab-co-formulated-with-enhanze-for-the-treatment-of-patients-with-advanced-egfr-mutated-non-small-cell-lung-cancer","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/chmp-issues-positive-opinion-for-subcutaneous-rybrevantamivantamab-co-formulated-with-enhanze-for-the-treatment-of-patients-with-advanced-egfr-mutated-non-small-cell-lung-cancer\/","title":{"rendered":"CHMP Issues Positive Opinion for Subcutaneous RYBREVANT\u00ae(amivantamab) Co-Formulated with ENHANZE\u00ae for the Treatment of Patients with Advanced EGFR-Mutated Non-Small Cell Lung Cancer"},"content":{"rendered":"<div class=\"xn-newslines\">\n<p class=\"xn-distributor\">PR Newswire<\/p>\n<\/p><\/div>\n<div class=\"xn-content\">\n<p>\n        <span class=\"legendSpanClass\"><br \/>\n          <span class=\"xn-location\">SAN DIEGO<\/span><br \/>\n        <\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">Feb. 3, 2025<\/span><\/span> \/PRNewswire\/ &#8212; Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Janssen-Cilag International NV, a Johnson &amp; Johnson company, received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommending an extension of marketing authorisation for a subcutaneous (SC) formulation of RYBREVANT\u00ae (amivantamab) in combination with LAZCLUZE\u00ae\u00a0(lazertinib) for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, and as a monotherapy for the treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy.<\/p>\n<p>&#8220;We are pleased that the subcutaneous formulation of amivantamab, which was developed with our ENHANZE drug delivery technology, was recommended for approval in <span class=\"xn-location\">Europe<\/span>,&#8221; said Dr. <span class=\"xn-person\">Helen Torley<\/span>, president and chief executive officer of Halozyme. &#8220;The data that support the recommendation could represent a very compelling proposition for patients with the approximate five-minute administration time and five-fold reduction in infusion related reactions.&#8221;<\/p>\n<p>The CHMP positive opinion is supported by positive results from the Phase 3 PALOMA-3 study (NCT05388669). For more information on the study and its findings, please view Johnson &amp; Johnson&#8217;s press release issued today.<\/p>\n<p>Subcutaneous amivantamab is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme&#8217;s ENHANZE\u00ae drug delivery technology.\u00a0<\/p>\n<p>\n        <sup>1<\/sup>\u00a0Leighl NB et al. Subcutaneous Versus Intravenous Amivantamab, Both in Combination With Lazertinib, in Refractory Epidermal Growth Factor Receptor\u2013Mutated Non\u2013Small Cell Lung Cancer: Primary Results From the Phase III PALOMA-3 Study. ASCO Journal of Clinical Oncology. 2024;42(3):3593-3605.<\/p>\n<p>\n        <sup>2<\/sup>\u00a0Leighl NB, et al. Subcutaneous Versus Intravenous Amivantamab, Both in Combination With Lazertinib, in Refractory Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer: Primary Results From the Phase III PALOMA-3 Study. J Clin Oncol. 2024 Oct 20;42(30):3593-3605.<\/p>\n<p>\n        <sup>3<\/sup>\u00a0ClinicalTrials.gov. A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer (PALOMA-3). <a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=4353702-1&amp;h=3298097608&amp;u=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT05388669.%2520Accessed%2520January%25202025&amp;a=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT05388669.+Accessed+January+2025\" target=\"_blank\" rel=\"nofollow\">https:\/\/clinicaltrials.gov\/ct2\/show\/NCT05388669. Accessed <span class=\"xn-chron\">January 2025<\/span><\/a>.<\/p>\n<p>\n        <b>About Halozyme<\/b>\n      <\/p>\n<p>Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE\u00ae drug delivery technology with the proprietary enzyme rHuPH20, Halozyme&#8217;s commercially-validated solution is used to facilitate the subcutaneous delivery of injected drugs and fluids, with the goal of improving the patient experience with rapid subcutaneous delivery and reduced treatment burden. Having touched one million patient lives in post-marketing use in nine commercialized products across more than 100 global markets, Halozyme has licensed its ENHANZE\u00ae technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals.<\/p>\n<p>Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and tolerability, and enhanced patient comfort and adherence. The Company has two commercial proprietary products, Hylenex\u00ae and XYOSTED\u00ae, partnered commercial products and ongoing product development programs with Teva Pharmaceuticals and Idorsia Pharmaceuticals.<\/p>\n<p>Halozyme is headquartered in <span class=\"xn-location\">San Diego, CA<\/span> and has offices in <span class=\"xn-location\">Ewing, NJ<\/span> and <span class=\"xn-location\">Minnetonka, MN.<\/span><span class=\"xn-location\">Minnetonka<\/span> is also the site of its operations facility.<\/p>\n<p>For more information visit <a href=\"http:\/\/www.halozyme.com\" rel=\"nofollow\">www.halozyme.com<\/a> and connect with us on LinkedIn and Twitter.<\/p>\n<p>\n        <b>Safe Harbor Statement<\/b>\n      <\/p>\n<p>In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE\u00ae, the possible method of action of ENHANZE\u00ae, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE\u00ae including facilitating more rapid delivery of injectable medications through subcutaneous delivery and potentially lowering the treatment burden for patients, including a potential reduction in administration time and infusion related reactionsand broadening the treatment options for the indications referred to in this press release. Forward-looking statements may also include statements regarding the product development efforts of Halozyme&#8217;s ENHANZE\u00ae partner and the potential approval of an extension of marketing authorization for the subcutaneous formulation\u00a0referred to in this press release. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words &#8220;expect,&#8221; &#8220;believe,&#8221; &#8220;enable,&#8221; &#8220;may,&#8221; &#8220;will,&#8221; &#8220;could,&#8221; &#8220;intends,&#8221; &#8220;estimate,&#8221; &#8220;anticipate,&#8221; &#8220;plan,&#8221; &#8220;predict,&#8221; &#8220;probable,&#8221; &#8220;potential,&#8221; &#8220;possible,&#8221; &#8220;should,&#8221; &#8220;continue,&#8221; and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including uncertainties concerning whether the extension of marketing authorization for the subcutaneous formulation referred to in this press release is ultimately approved, unexpected results or delays in the launch or commercialization of our partner&#8217;s product for the indication referred to in this press release, unexpected adverse events or patient experiences or outcomes from being treated with the ENHANZE\u00ae co-formulated treatment referred to in this press release, and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme&#8217;s most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.<\/p>\n<p>\n        <b>Contacts:<\/b>\n      <\/p>\n<p>Tram Bui<br \/>VP, Investor Relations and Corporate Communications<br \/>609-333-7668<br \/><a href=\"mailto:tbui@halozyme.com\" rel=\"nofollow\">tbui@halozyme.com<\/a><\/p>\n<p>\n        <span class=\"xn-person\">Samantha Gaspar<\/span><br \/>\n        <br \/>Teneo <br \/>212-886-9356 <br \/><a href=\"mailto:samantha.gaspar@teneo.com\" rel=\"nofollow\">samantha.gaspar@teneo.com<\/a><\/p>\n<div class=\"PRN_ImbeddedAssetReference\" id=\"DivAssetPlaceHolder7265\">\n<p>\n          <a href=\"https:\/\/mma.prnewswire.com\/media\/75076\/halozyme_therapeutics_logo_Logo.html\" target=\"_blank\" rel=\"nofollow\"><br \/>\n            <img decoding=\"async\" src=\"https:\/\/mma.prnewswire.com\/media\/75076\/halozyme_therapeutics_logo_Logo.jpg\" title=\"Halozyme Therapeutics, Inc. Logo. (PRNewsFoto\/Halozyme Therapeutics, Inc.) (PRNewsfoto\/Halozyme Therapeutics, Inc.)\" alt=\"Halozyme Therapeutics, Inc. Logo. (PRNewsFoto\/Halozyme Therapeutics, Inc.) (PRNewsfoto\/Halozyme Therapeutics, Inc.)\" \/><br \/>\n          <\/a>\n        <\/p>\n<\/p><\/div>\n<p>\u00a0<\/p>\n<div class=\"PRN_ImbeddedAssetReference\" id=\"DivAssetPlaceHolder0\"><\/div>\n<p id=\"PURL\">\n        <img loading=\"lazy\" decoding=\"async\" title=\"Cision\" width=\"12\" height=\"12\" alt=\"Cision\" src=\"https:\/\/c212.net\/c\/img\/favicon.png?sn=LA09978&amp;sd=2025-02-03\" \/> View original content to download multimedia:<a id=\"PRNURL\" rel=\"nofollow\" href=\"https:\/\/www.prnewswire.com\/news-releases\/chmp-issues-positive-opinion-for-subcutaneous-rybrevantamivantamab-co-formulated-with-enhanze-for-the-treatment-of-patients-with-advanced-egfr-mutated-non-small-cell-lung-cancer-302366353.html\" target=\"_blank\">https:\/\/www.prnewswire.com\/news-releases\/chmp-issues-positive-opinion-for-subcutaneous-rybrevantamivantamab-co-formulated-with-enhanze-for-the-treatment-of-patients-with-advanced-egfr-mutated-non-small-cell-lung-cancer-302366353.html<\/a><\/p>\n<p>SOURCE  Halozyme Therapeutics, Inc.<\/p>\n<\/p><\/div>\n<p>    <img decoding=\"async\" alt=\"\" src=\"https:\/\/rt.prnewswire.com\/rt.gif?NewsItemId=LA09978&amp;Transmission_Id=202502030730PR_NEWS_USPR_____LA09978&amp;DateId=20250203\" style=\"border:0px;width:1px;height:1px\" \/><\/p>\n","protected":false},"excerpt":{"rendered":"<p>PR Newswire SAN DIEGO , Feb. 3, 2025 \/PRNewswire\/ &#8212; Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Janssen-Cilag International NV, a Johnson &amp; Johnson company, received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommending an extension of marketing authorisation for a subcutaneous (SC) formulation of RYBREVANT\u00ae (amivantamab) in combination with LAZCLUZE\u00ae\u00a0(lazertinib) for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, and as a monotherapy for the treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy. &#8220;We are &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/chmp-issues-positive-opinion-for-subcutaneous-rybrevantamivantamab-co-formulated-with-enhanze-for-the-treatment-of-patients-with-advanced-egfr-mutated-non-small-cell-lung-cancer\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;CHMP Issues Positive Opinion for Subcutaneous RYBREVANT\u00ae(amivantamab) Co-Formulated with ENHANZE\u00ae for the Treatment of Patients with Advanced EGFR-Mutated Non-Small Cell Lung Cancer&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-807700","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>CHMP Issues Positive Opinion for Subcutaneous RYBREVANT\u00ae(amivantamab) Co-Formulated with ENHANZE\u00ae for the Treatment of Patients with Advanced EGFR-Mutated Non-Small Cell Lung Cancer - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/chmp-issues-positive-opinion-for-subcutaneous-rybrevantamivantamab-co-formulated-with-enhanze-for-the-treatment-of-patients-with-advanced-egfr-mutated-non-small-cell-lung-cancer\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CHMP Issues Positive Opinion for Subcutaneous RYBREVANT\u00ae(amivantamab) Co-Formulated with ENHANZE\u00ae for the Treatment of Patients with Advanced EGFR-Mutated Non-Small Cell Lung Cancer - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"PR Newswire SAN DIEGO , Feb. 3, 2025 \/PRNewswire\/ &#8212; Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Janssen-Cilag International NV, a Johnson &amp; Johnson company, received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommending an extension of marketing authorisation for a subcutaneous (SC) formulation of RYBREVANT\u00ae (amivantamab) in combination with LAZCLUZE\u00ae\u00a0(lazertinib) for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, and as a monotherapy for the treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy. &#8220;We are &hellip; Continue reading &quot;CHMP Issues Positive Opinion for Subcutaneous RYBREVANT\u00ae(amivantamab) Co-Formulated with ENHANZE\u00ae for the Treatment of Patients with Advanced EGFR-Mutated Non-Small Cell Lung Cancer&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/chmp-issues-positive-opinion-for-subcutaneous-rybrevantamivantamab-co-formulated-with-enhanze-for-the-treatment-of-patients-with-advanced-egfr-mutated-non-small-cell-lung-cancer\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2025-02-03T12:35:09+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/mma.prnewswire.com\/media\/75076\/halozyme_therapeutics_logo_Logo.jpg\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/chmp-issues-positive-opinion-for-subcutaneous-rybrevantamivantamab-co-formulated-with-enhanze-for-the-treatment-of-patients-with-advanced-egfr-mutated-non-small-cell-lung-cancer\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/chmp-issues-positive-opinion-for-subcutaneous-rybrevantamivantamab-co-formulated-with-enhanze-for-the-treatment-of-patients-with-advanced-egfr-mutated-non-small-cell-lung-cancer\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"CHMP Issues Positive Opinion for Subcutaneous RYBREVANT\u00ae(amivantamab) Co-Formulated with ENHANZE\u00ae for the Treatment of Patients with Advanced EGFR-Mutated Non-Small Cell Lung Cancer\",\"datePublished\":\"2025-02-03T12:35:09+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/chmp-issues-positive-opinion-for-subcutaneous-rybrevantamivantamab-co-formulated-with-enhanze-for-the-treatment-of-patients-with-advanced-egfr-mutated-non-small-cell-lung-cancer\\\/\"},\"wordCount\":950,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/chmp-issues-positive-opinion-for-subcutaneous-rybrevantamivantamab-co-formulated-with-enhanze-for-the-treatment-of-patients-with-advanced-egfr-mutated-non-small-cell-lung-cancer\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/mma.prnewswire.com\\\/media\\\/75076\\\/halozyme_therapeutics_logo_Logo.jpg\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/chmp-issues-positive-opinion-for-subcutaneous-rybrevantamivantamab-co-formulated-with-enhanze-for-the-treatment-of-patients-with-advanced-egfr-mutated-non-small-cell-lung-cancer\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/chmp-issues-positive-opinion-for-subcutaneous-rybrevantamivantamab-co-formulated-with-enhanze-for-the-treatment-of-patients-with-advanced-egfr-mutated-non-small-cell-lung-cancer\\\/\",\"name\":\"CHMP Issues Positive Opinion for Subcutaneous RYBREVANT\u00ae(amivantamab) Co-Formulated with ENHANZE\u00ae for the Treatment of Patients with Advanced EGFR-Mutated Non-Small Cell Lung Cancer - Market Newsdesk\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/chmp-issues-positive-opinion-for-subcutaneous-rybrevantamivantamab-co-formulated-with-enhanze-for-the-treatment-of-patients-with-advanced-egfr-mutated-non-small-cell-lung-cancer\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/chmp-issues-positive-opinion-for-subcutaneous-rybrevantamivantamab-co-formulated-with-enhanze-for-the-treatment-of-patients-with-advanced-egfr-mutated-non-small-cell-lung-cancer\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/mma.prnewswire.com\\\/media\\\/75076\\\/halozyme_therapeutics_logo_Logo.jpg\",\"datePublished\":\"2025-02-03T12:35:09+00:00\",\"author\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"breadcrumb\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/chmp-issues-positive-opinion-for-subcutaneous-rybrevantamivantamab-co-formulated-with-enhanze-for-the-treatment-of-patients-with-advanced-egfr-mutated-non-small-cell-lung-cancer\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/chmp-issues-positive-opinion-for-subcutaneous-rybrevantamivantamab-co-formulated-with-enhanze-for-the-treatment-of-patients-with-advanced-egfr-mutated-non-small-cell-lung-cancer\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/chmp-issues-positive-opinion-for-subcutaneous-rybrevantamivantamab-co-formulated-with-enhanze-for-the-treatment-of-patients-with-advanced-egfr-mutated-non-small-cell-lung-cancer\\\/#primaryimage\",\"url\":\"https:\\\/\\\/mma.prnewswire.com\\\/media\\\/75076\\\/halozyme_therapeutics_logo_Logo.jpg\",\"contentUrl\":\"https:\\\/\\\/mma.prnewswire.com\\\/media\\\/75076\\\/halozyme_therapeutics_logo_Logo.jpg\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/chmp-issues-positive-opinion-for-subcutaneous-rybrevantamivantamab-co-formulated-with-enhanze-for-the-treatment-of-patients-with-advanced-egfr-mutated-non-small-cell-lung-cancer\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"CHMP Issues Positive Opinion for Subcutaneous RYBREVANT\u00ae(amivantamab) Co-Formulated with ENHANZE\u00ae for the Treatment of Patients with Advanced EGFR-Mutated Non-Small Cell Lung Cancer\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#website\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/\",\"name\":\"Market Newsdesk\",\"description\":\"Latest Business News in Real Time\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\",\"name\":\"Newsdesk\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/a0d0bd5b0f0ca12a265a459b13169dac35f33776d8501eda5e68844a366f2f46?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/a0d0bd5b0f0ca12a265a459b13169dac35f33776d8501eda5e68844a366f2f46?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/a0d0bd5b0f0ca12a265a459b13169dac35f33776d8501eda5e68844a366f2f46?s=96&d=mm&r=g\",\"caption\":\"Newsdesk\"},\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/author\\\/newsdesk\\\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"CHMP Issues Positive Opinion for Subcutaneous RYBREVANT\u00ae(amivantamab) Co-Formulated with ENHANZE\u00ae for the Treatment of Patients with Advanced EGFR-Mutated Non-Small Cell Lung Cancer - Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/chmp-issues-positive-opinion-for-subcutaneous-rybrevantamivantamab-co-formulated-with-enhanze-for-the-treatment-of-patients-with-advanced-egfr-mutated-non-small-cell-lung-cancer\/","og_locale":"en_US","og_type":"article","og_title":"CHMP Issues Positive Opinion for Subcutaneous RYBREVANT\u00ae(amivantamab) Co-Formulated with ENHANZE\u00ae for the Treatment of Patients with Advanced EGFR-Mutated Non-Small Cell Lung Cancer - Market Newsdesk","og_description":"PR Newswire SAN DIEGO , Feb. 3, 2025 \/PRNewswire\/ &#8212; Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Janssen-Cilag International NV, a Johnson &amp; Johnson company, received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommending an extension of marketing authorisation for a subcutaneous (SC) formulation of RYBREVANT\u00ae (amivantamab) in combination with LAZCLUZE\u00ae\u00a0(lazertinib) for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, and as a monotherapy for the treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy. &#8220;We are &hellip; Continue reading \"CHMP Issues Positive Opinion for Subcutaneous RYBREVANT\u00ae(amivantamab) Co-Formulated with ENHANZE\u00ae for the Treatment of Patients with Advanced EGFR-Mutated Non-Small Cell Lung Cancer\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/chmp-issues-positive-opinion-for-subcutaneous-rybrevantamivantamab-co-formulated-with-enhanze-for-the-treatment-of-patients-with-advanced-egfr-mutated-non-small-cell-lung-cancer\/","og_site_name":"Market Newsdesk","article_published_time":"2025-02-03T12:35:09+00:00","og_image":[{"url":"https:\/\/mma.prnewswire.com\/media\/75076\/halozyme_therapeutics_logo_Logo.jpg","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"5 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/chmp-issues-positive-opinion-for-subcutaneous-rybrevantamivantamab-co-formulated-with-enhanze-for-the-treatment-of-patients-with-advanced-egfr-mutated-non-small-cell-lung-cancer\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/chmp-issues-positive-opinion-for-subcutaneous-rybrevantamivantamab-co-formulated-with-enhanze-for-the-treatment-of-patients-with-advanced-egfr-mutated-non-small-cell-lung-cancer\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"CHMP Issues Positive Opinion for Subcutaneous RYBREVANT\u00ae(amivantamab) Co-Formulated with ENHANZE\u00ae for the Treatment of Patients with Advanced EGFR-Mutated Non-Small Cell Lung Cancer","datePublished":"2025-02-03T12:35:09+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/chmp-issues-positive-opinion-for-subcutaneous-rybrevantamivantamab-co-formulated-with-enhanze-for-the-treatment-of-patients-with-advanced-egfr-mutated-non-small-cell-lung-cancer\/"},"wordCount":950,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/chmp-issues-positive-opinion-for-subcutaneous-rybrevantamivantamab-co-formulated-with-enhanze-for-the-treatment-of-patients-with-advanced-egfr-mutated-non-small-cell-lung-cancer\/#primaryimage"},"thumbnailUrl":"https:\/\/mma.prnewswire.com\/media\/75076\/halozyme_therapeutics_logo_Logo.jpg","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/chmp-issues-positive-opinion-for-subcutaneous-rybrevantamivantamab-co-formulated-with-enhanze-for-the-treatment-of-patients-with-advanced-egfr-mutated-non-small-cell-lung-cancer\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/chmp-issues-positive-opinion-for-subcutaneous-rybrevantamivantamab-co-formulated-with-enhanze-for-the-treatment-of-patients-with-advanced-egfr-mutated-non-small-cell-lung-cancer\/","name":"CHMP Issues Positive Opinion for Subcutaneous RYBREVANT\u00ae(amivantamab) Co-Formulated with ENHANZE\u00ae for the Treatment of Patients with Advanced EGFR-Mutated Non-Small Cell Lung Cancer - Market Newsdesk","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/chmp-issues-positive-opinion-for-subcutaneous-rybrevantamivantamab-co-formulated-with-enhanze-for-the-treatment-of-patients-with-advanced-egfr-mutated-non-small-cell-lung-cancer\/#primaryimage"},"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/chmp-issues-positive-opinion-for-subcutaneous-rybrevantamivantamab-co-formulated-with-enhanze-for-the-treatment-of-patients-with-advanced-egfr-mutated-non-small-cell-lung-cancer\/#primaryimage"},"thumbnailUrl":"https:\/\/mma.prnewswire.com\/media\/75076\/halozyme_therapeutics_logo_Logo.jpg","datePublished":"2025-02-03T12:35:09+00:00","author":{"@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"breadcrumb":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/chmp-issues-positive-opinion-for-subcutaneous-rybrevantamivantamab-co-formulated-with-enhanze-for-the-treatment-of-patients-with-advanced-egfr-mutated-non-small-cell-lung-cancer\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.marketnewsdesk.com\/index.php\/chmp-issues-positive-opinion-for-subcutaneous-rybrevantamivantamab-co-formulated-with-enhanze-for-the-treatment-of-patients-with-advanced-egfr-mutated-non-small-cell-lung-cancer\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/chmp-issues-positive-opinion-for-subcutaneous-rybrevantamivantamab-co-formulated-with-enhanze-for-the-treatment-of-patients-with-advanced-egfr-mutated-non-small-cell-lung-cancer\/#primaryimage","url":"https:\/\/mma.prnewswire.com\/media\/75076\/halozyme_therapeutics_logo_Logo.jpg","contentUrl":"https:\/\/mma.prnewswire.com\/media\/75076\/halozyme_therapeutics_logo_Logo.jpg"},{"@type":"BreadcrumbList","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/chmp-issues-positive-opinion-for-subcutaneous-rybrevantamivantamab-co-formulated-with-enhanze-for-the-treatment-of-patients-with-advanced-egfr-mutated-non-small-cell-lung-cancer\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.marketnewsdesk.com\/"},{"@type":"ListItem","position":2,"name":"CHMP Issues Positive Opinion for Subcutaneous RYBREVANT\u00ae(amivantamab) Co-Formulated with ENHANZE\u00ae for the Treatment of Patients with Advanced EGFR-Mutated Non-Small Cell Lung Cancer"}]},{"@type":"WebSite","@id":"https:\/\/www.marketnewsdesk.com\/#website","url":"https:\/\/www.marketnewsdesk.com\/","name":"Market Newsdesk","description":"Latest Business News in Real Time","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.marketnewsdesk.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Person","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979","name":"Newsdesk","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/a0d0bd5b0f0ca12a265a459b13169dac35f33776d8501eda5e68844a366f2f46?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/a0d0bd5b0f0ca12a265a459b13169dac35f33776d8501eda5e68844a366f2f46?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/a0d0bd5b0f0ca12a265a459b13169dac35f33776d8501eda5e68844a366f2f46?s=96&d=mm&r=g","caption":"Newsdesk"},"url":"https:\/\/www.marketnewsdesk.com\/index.php\/author\/newsdesk\/"}]}},"_links":{"self":[{"href":"https:\/\/www.marketnewsdesk.com\/index.php\/wp-json\/wp\/v2\/posts\/807700","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.marketnewsdesk.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.marketnewsdesk.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.marketnewsdesk.com\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.marketnewsdesk.com\/index.php\/wp-json\/wp\/v2\/comments?post=807700"}],"version-history":[{"count":0,"href":"https:\/\/www.marketnewsdesk.com\/index.php\/wp-json\/wp\/v2\/posts\/807700\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.marketnewsdesk.com\/index.php\/wp-json\/wp\/v2\/media?parent=807700"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.marketnewsdesk.com\/index.php\/wp-json\/wp\/v2\/categories?post=807700"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.marketnewsdesk.com\/index.php\/wp-json\/wp\/v2\/tags?post=807700"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}