{"id":446632,"date":"2021-03-01T07:03:14","date_gmt":"2021-03-01T12:03:14","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=446632"},"modified":"2021-03-01T07:03:14","modified_gmt":"2021-03-01T12:03:14","slug":"athenex-receives-fda-complete-response-letter-for-oral-paclitaxel-plus-encequidar-for-the-treatment-of-metastatic-breast-cancer","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/athenex-receives-fda-complete-response-letter-for-oral-paclitaxel-plus-encequidar-for-the-treatment-of-metastatic-breast-cancer\/","title":{"rendered":"Athenex Receives FDA Complete Response Letter for Oral Paclitaxel Plus Encequidar for the Treatment of Metastatic Breast Cancer"},"content":{"rendered":"<div class=\"mw_release\">\n<ul>\n<li style=\"text-align:left\">\n          <em>Conference call and webcast scheduled for today at 8:00 a.m. ET<\/em>\n        <\/li>\n<\/ul>\n<p align=\"justify\">BUFFALO, N.Y., March  01, 2021  (GLOBE NEWSWIRE) &#8212; Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the company\u2019s New Drug Application (NDA) for oral paclitaxel plus encequidar for the treatment of metastatic breast cancer. The FDA issues a CRL to indicate that the review cycle for an application is complete and that the application is not ready for approval in its present form.<\/p>\n<p align=\"justify\">In the CRL, the FDA indicated its concern of safety risk to patients in terms of an increase in neutropenia-related sequelae on the Oral Paclitaxel arm compared with the IV paclitaxel arm.<\/p>\n<p align=\"justify\">The FDA also expressed concerns regarding the uncertainty over the results of the primary endpoint of objective response rate (ORR) at week 19 conducted by blinded independent central review (BICR). The Agency stated that the BICR reconciliation and re-read process may have introduced unmeasured bias and influence on the BICR.<\/p>\n<p align=\"justify\">The agency recommended that Athenex conduct a new adequate and well-conducted clinical trial in a patient population with metastatic breast cancer representative of the population in the U.S. The Agency determined that additional risk mitigation strategies to improve toxicity, which may involve dose optimization and \/ or exclusion of patients deemed to be at higher risk of toxicity, are required to support potential approval of the NDA.<\/p>\n<p align=\"justify\">Athenex plans to request a meeting with the FDA to discuss the Agency\u2019s response, engage in a dialogue on the design and scope of a clinical trial to address the FDA\u2019s requirements and align on the next steps required to obtain approval.<\/p>\n<p align=\"justify\">\u201cOur clinical and regulatory teams are disappointed by the complete response letter,\u201d said Dr. Rudolf Kwan, Chief Medical Officer of Athenex. \u201cWe plan to work with the Agency to resolve the issues raised in the CRL and to obtain approval for oral paclitaxel plus encequidar in metastatic breast cancer.\u201d<\/p>\n<p align=\"justify\">Dr. Johnson Lau, Chief Executive Officer of Athenex, added, \u201cWe remain committed to the breast cancer community and will explore the best path forward to obtain regulatory approval. In the interim, we will identify and undertake the appropriate internal organizational adjustments accordingly.\u201d<\/p>\n<p align=\"justify\">\n        <strong><br \/>\n          <u>Webcast and Conference Call<\/u><br \/>\n        <\/strong>\n      <\/p>\n<p align=\"justify\">Athenex will host a webcast and conference call today Monday, March 1, 2021, at 8 a.m. ET to discuss this regulatory update for oral paclitaxel, as well as the company\u2019s fourth quarter and full year 2020 financial results. The live call may be access by dialing <strong>(877) 407 \u2013 0784 (domestic)<\/strong> or <strong>(201) 689-8560 (international)<\/strong> fifteen minutes before the conference call begins and reference the passcode <strong>13715950<\/strong>. The live conference call and replay can also be accessed via audio webcast at the Investor Relations section of the Company\u2019s website, located at <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=_5SWBszel7W36PZozzDovNDUk4ig0ieZqlE59CSHMN5NkYsBioD-FHsi77oC_769hSt9qnomHRiD3TvlBEPHgSsRCTQ9i7HOJ6mQU359-9g=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">http:\/\/ir.athenex.com\/<\/a>.<\/p>\n<p>\n        <strong><br \/>\n          <u>About\u00a0Athenex, Inc.<\/u><br \/>\n        <\/strong>\n      <\/p>\n<p align=\"justify\">Founded in 2003,\u00a0Athenex, Inc.\u00a0is a global clinical stage biopharmaceutical company dedicated to becoming a leader in the discovery, development, and commercialization of next generation drugs for the treatment of cancer.\u00a0Athenex\u00a0is organized around three platforms, including an Oncology Innovation Platform, a Commercial Platform, and a Global Supply Chain Platform. The Company\u2019s current clinical pipeline is derived from four different platform technologies: (1) Orascovery, based on P-glycoprotein inhibitor, (2) Src kinase inhibition, (3) T-cell receptor-engineered T-cells (TCR-T), and (4) Arginine deprivation therapy. Athenex\u2019s employees worldwide are dedicated to improving the lives of cancer patients by creating more active and tolerable treatments. Athenex\u00a0has offices in\u00a0Buffalo\u00a0and\u00a0Clarence, New York;\u00a0Cranford, New Jersey;\u00a0Houston, Texas;\u00a0Chicago, Illinois;\u00a0Hong Kong;\u00a0Taipei,\u00a0Taiwan; multiple locations in\u00a0Chongqing, China;\u00a0Manchester, UK;\u00a0Guatemala City,\u00a0Guatemala\u00a0and\u00a0Buenos Aires, Argentina. For more information, please visit\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=GQhFgrCqNxulcHtxywC0he45MpuucXZAM0gY2WAvAqW5ydFOTurs_X4tVYNU4WkMX9zDr_2U9Z1CXfdn9fHoGQ==\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">www.athenex.com<\/a>.<\/p>\n<p>\n        <strong><br \/>\n          <u>Forward-Looking Statements<\/u><br \/>\n        <\/strong>\n      <\/p>\n<p align=\"justify\">Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. These forward-looking statements are typically identified by terms such as \u201canticipate,\u201d \u201cbelieve,\u201d \u201ccontinue,\u201d \u201ccould,\u201d \u201cestimate,\u201d \u201cexpect,\u201d \u201cforesee,\u201d \u201cgoal,\u201d \u201cguidance,\u201d \u201cintend,\u201d \u201clikely,\u201d \u201cmay,\u201d \u201cplan,\u201d \u201cpotential,\u201d \u201cpredict,\u201d \u201cpreliminary,\u201d \u201cprobable,\u201d \u201cproject,\u201d \u201cpromising,\u201d \u201cseek,\u201d \u201cshould,\u201d \u201cwill,\u201d \u201cwould,\u201d and similar expressions. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: the development stage of our primary clinical candidates and related risks involved in drug development, clinical trials, regulation, manufacturing and commercialization; risks related to counterparty performance, including our reliance on third parties for success in certain areas of Athenex\u2019s business; our history of operating losses and need to raise additional capital; uncertainties around our ability to meet funding conditions under our financing agreements and access to capital thereunder; risks and uncertainties related to the COVID-19 pandemic and its potential impact on our operations, cash flow and financial condition; competition; intellectual property risks; risks relating to doing business internationally and in\u00a0China; the risk of production slowdowns or stoppages or other interruptions at our\u00a0Chongqing\u00a0facilities; and the other risk factors set forth from time to time in our\u00a0SEC\u00a0filings, copies of which are available for free in the Investor Relations section of our website at\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=_5SWBszel7W36PZozzDovNDUk4ig0ieZqlE59CSHMN7yf0Uhp23eB6LoNxga1NV6oNKbFvxhpsb08-9pNNJZqnw0FVBhMkZxZpq4p8LVJY-HAJPPebYpyI79Bo9fUZF0eHsCWLHkRNyGQ3rwKeTZ4SjanWEW7WnNMAADQ4HIjx4CNK0oWjTzKJBSORc4p7rNyVyPCyG_S_U_KIBo8WMuNQ==\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">http:\/\/ir.athenex.com\/phoenix.zhtml?c=254495&amp;p=irol-sec<\/a>\u00a0or upon request from our Investor Relations Department. All information provided in this release is as of the date hereof and we assume no obligation and do not intend to update these forward-looking statements, except as required by law.<\/p>\n<p align=\"justify\">\n        <strong>CONTACTS<\/strong>\n      <\/p>\n<p>\n        <u>Investors<\/u>\n      <\/p>\n<p>Steve Rubis<br \/>Athenex, Inc.<br \/>Email:\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=u-lBP5y3vmMQUVHmiDC-8kRmDp0yohwYRd_bq_e7gH8Qxyk2UazGUyzBNb67J6cv1p2y69do6NHP_u5u5zfWgGlEdih54FKgUOdn5LbsCxk=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">stevenrubis@athenex.com<\/a><\/p>\n<p>Daniel Lang, MD<br \/>Athenex, Inc.<br \/>Email:\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=psgCvhMAYP5acmB3uw8riI-efz5JEVkYUytx6crzZrlSd3Wb5D8I8EOyiAWMz-gr2dgyGR6HPXlSt757yOP7TcxTv1WO3kGexkEnPj8rQdE=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">danlang@athenex.com<\/a><\/p>\n<p>Tim McCarthy<br \/>LifeSci Advisors, LLC<br \/>Email:\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=L3i7h1HNqoH6gRXcOW6VMLUZUU0HiUvlzh3_LxPkzH1w1ihvHAg6BN8Aq36QMawjAdqnmTRnEwKE_a7ZCmaHrbOOd9MuEZemV6cKe-topas=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">tim@lifesciadvisors.com<\/a>\u00a0<\/p>\n<p>      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODE4MTUzNyM0MDQwNjg3IzIwODQ0OTg=\" width=\"1\" height=\"1\" \/><br \/>\n      <br \/>\n      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/ml.globenewswire.com\/release\/track\/de8a3c1f-6b38-4f99-9d90-9788c44d1fca\" width=\"1\" height=\"1\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Conference call and webcast scheduled for today at 8:00 a.m. ET BUFFALO, N.Y., March 01, 2021 (GLOBE NEWSWIRE) &#8212; Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the company\u2019s New Drug Application (NDA) for oral paclitaxel plus encequidar for the treatment of metastatic breast cancer. The FDA issues a CRL to indicate that the review cycle for an application is complete and that the application is not ready for approval in its present form. In the CRL, the FDA indicated its concern of safety &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/athenex-receives-fda-complete-response-letter-for-oral-paclitaxel-plus-encequidar-for-the-treatment-of-metastatic-breast-cancer\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Athenex Receives FDA Complete Response Letter for Oral Paclitaxel Plus Encequidar for the Treatment of Metastatic Breast 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-446632","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Athenex Receives FDA Complete Response Letter for Oral Paclitaxel Plus Encequidar for the Treatment of Metastatic Breast 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\/athenex-receives-fda-complete-response-letter-for-oral-paclitaxel-plus-encequidar-for-the-treatment-of-metastatic-breast-cancer\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Athenex Receives FDA Complete Response Letter for Oral Paclitaxel Plus Encequidar for the Treatment of Metastatic Breast Cancer - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Conference call and webcast scheduled for today at 8:00 a.m. ET BUFFALO, N.Y., March 01, 2021 (GLOBE NEWSWIRE) &#8212; Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the company\u2019s New Drug Application (NDA) for oral paclitaxel plus encequidar for the treatment of metastatic breast cancer. The FDA issues a CRL to indicate that the review cycle for an application is complete and that the application is not ready for approval in its present form. 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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\/athenex-receives-fda-complete-response-letter-for-oral-paclitaxel-plus-encequidar-for-the-treatment-of-metastatic-breast-cancer\/","og_locale":"en_US","og_type":"article","og_title":"Athenex Receives FDA Complete Response Letter for Oral Paclitaxel Plus Encequidar for the Treatment of Metastatic Breast Cancer - Market Newsdesk","og_description":"Conference call and webcast scheduled for today at 8:00 a.m. ET BUFFALO, N.Y., March 01, 2021 (GLOBE NEWSWIRE) &#8212; Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the company\u2019s New Drug Application (NDA) for oral paclitaxel plus encequidar for the treatment of metastatic breast cancer. The FDA issues a CRL to indicate that the review cycle for an application is complete and that the application is not ready for approval in its present form. 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