Nuvalent Inc. Announces FDA's Acceptance of NDA for Zidesamtinib in ROS1-Positive NSCLC Under Real-Time Oncology Review Program

Reuters

Jun 24, 2025

Nuvalent Inc. Announces FDA's Acceptance of NDA for Zidesamtinib in ROS1-Positive NSCLC Under Real-Time Oncology Review Program

Nuvalent Inc. announced on June 24, 2025, that it has reached a significant milestone in its regulatory journey with the U.S. Food and Drug Administration (FDA). The company has successfully completed a pre-New Drug Application (NDA) meeting with the FDA for its novel ROS1-selective inhibitor, zidesamtinib, intended for the treatment of tyrosine kinase inhibitor (TKI) pre-treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC). The FDA has agreed to accept the NDA under the Real-Time Oncology Review (RTOR) pilot program, allowing for an earlier evaluation of the application. Nuvalent plans to begin a rolling NDA submission in July 2025, with completion targeted for the third quarter of the year. This development marks a pivotal step forward in bringing zidesamtinib to market for patients in need.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Nuvalent Inc. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0000950170-25-089213), on June 24, 2025, and is solely responsible for the information contained therein.

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Announces FDA's Acceptance of NDA for Zidesamtinib in ROS1-Positive NSCLC Under Real-Time Oncology Review Program","media":"Reuters","content":"<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      Nuvalent Inc. Announces FDA's Acceptance of NDA for Zidesamtinib in ROS1-Positive NSCLC Under Real-Time Oncology Review Program\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        Nuvalent Inc. announced on June 24, 2025, that it has reached a significant milestone in its regulatory journey with the U.S. Food and Drug Administration (FDA). 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Announces FDA's Acceptance of NDA for Zidesamtinib in ROS1-Positive NSCLC Under Real-Time Oncology Review Program\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1032215980\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Reuters </p>\n<p class=\"h-time\">2025-06-24 18:36</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      Nuvalent Inc. Announces FDA's Acceptance of NDA for Zidesamtinib in ROS1-Positive NSCLC Under Real-Time Oncology Review Program\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        Nuvalent Inc. announced on June 24, 2025, that it has reached a significant milestone in its regulatory journey with the U.S. Food and Drug Administration (FDA). The company has successfully completed a pre-New Drug Application (NDA) meeting with the FDA for its novel ROS1-selective inhibitor, zidesamtinib, intended for the treatment of tyrosine kinase inhibitor (TKI) pre-treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC). The FDA has agreed to accept the NDA under the Real-Time Oncology Review (RTOR) pilot program, allowing for an earlier evaluation of the application. Nuvalent plans to begin a rolling NDA submission in July 2025, with completion targeted for the third quarter of the year. 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Announces FDA's Acceptance of NDA for Zidesamtinib in ROS1-Positive NSCLC Under Real-Time Oncology Review Program. Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Nuvalent Inc. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission , on June 24, 2025, and is solely responsible for the information contained therein.","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4139":"生物科技","BK4539":"次新股","NUVL":"Nuvalent, Inc."},"translate_title":"Nuvalent Inc.宣布FDA根据实时肿瘤学审查计划接受Zidesamtinib治疗ROS1阳性非小细胞肺癌的NDA","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"NUVL":0.9},"content_text":"Nuvalent Inc. Announces FDA's Acceptance of NDA for Zidesamtinib in ROS1-Positive NSCLC Under Real-Time Oncology Review Program\n    \n\n        Nuvalent Inc. announced on June 24, 2025, that it has reached a significant milestone in its regulatory journey with the U.S. Food and Drug Administration (FDA). 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