FDA Expands Approval For AstraZeneca's Drug For Pediatric Patients With Rare Type Of Cancer

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Sep 11

On Wednesday, the U.S. Food and Drug Administration (FDA) approved AstraZeneca Plc’s AZN Koselugo (selumetinib) granules and capsules for pediatric patients 1 year of age and older with ...

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With Rare Type Of Cancer","media":"Benzinga_recent_news","content":"<div>\n<p>On Wednesday, the U.S. Food and Drug Administration (FDA) approved AstraZeneca Plc’s AZN Koselugo (selumetinib) granules and capsules for pediatric patients 1 year of age and older with ...</p>\n\n<a href=\"https://www.benzinga.com/news/fda/25/09/47606676/fda-expands-approval-for-astrazenecas-drug-for-pediatric-patients-with-rare-type-of-cancer\">Source Link</a>\n\n</div>\n","source":"benzinga_recent_news","html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>FDA Expands Approval For AstraZeneca's Drug For Pediatric Patients With Rare Type Of Cancer</title>\n<style 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AZN Koselugo (selumetinib) granules and capsules for pediatric patients 1 year of age and older with ...</p>\n\n<a href=\"https://www.benzinga.com/news/fda/25/09/47606676/fda-expands-approval-for-astrazenecas-drug-for-pediatric-patients-with-rare-type-of-cancer\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LU1429558221.USD","symbol_name":"Natixis Loomis Sayles US Growth Equity RA USD","start_time":0,"source_url":"https://www.benzinga.com/news/fda/25/09/47606676/fda-expands-approval-for-astrazenecas-drug-for-pediatric-patients-with-rare-type-of-cancer","article_id":"2566981120","we_media_id":null,"thumbnails":["https://cdn.benzinga.com/files/images/story/2025/09/10/Astrazeneca-U-s--Headquarters-In-Wilming.jpeg?optimize=medium&dpr=2&auto=webp&width=240"],"rights":{"source":"benzinga_recent_news","url":"https://www.benzinga.com/news/fda/25/09/47606676/fda-expands-approval-for-astrazenecas-drug-for-pediatric-patients-with-rare-type-of-cancer","rn_cache_url":null,"directOrigin":true},"url":"https://stock-news.laohu8.com/highlight/detail?id=2566981120","pubTimestamp":1757531100,"columns":[],"sourceInfo":{"source_id":"benzinga_recent_news","name":"Benzinga"},"weMediaInfo":null,"summary":"The FDA approved AstraZeneca's Koselugo for children 1+ with NF1 and inoperable nerve tumors, expanding treatment options with an established safe dose.","collect":0,"end_time":0,"defaultTopTitle":"benzinga.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"LU1429558221.USD":"Natixis Loomis Sayles US Growth Equity RA USD","BK4187":"航天航空与国防","BK4096":"电气部件与设备","BK4551":"寇图资本持仓","LU2326559502.SGD":"Natixis Loomis Sayles US Growth Equity P/A SGD-H","LU1435385759.SGD":"Natixis Loomis Sayles US Growth Equity RA SGD-H","BK4588":"碎股","IE000M9KFDE8.USD":"NEUBERGER BERMAN US LARGE CAP VALUE \"A\" (USD) ACC","BK4516":"特朗普概念","BA":"波音","BK4585":"ETF&股票定投概念","ORR":"Militia Long/Short Equity ETF","BK4564":"太空概念","PN":"斯凯蒙太阳能"},"translate_title":"FDA扩大对阿斯利康用于罕见癌症儿童患者药物的批准","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"BA":1,"ORR":1,"PN":1},"content_text":"On Wednesday, the U.S. Food and Drug Administration (FDA) approved AstraZeneca Plc’s AZN Koselugo (selumetinib) granules and capsules for pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN), benign, nerve sheath tumors.\nNeurofibromatosis is a group of genetic conditions causing non-cancerous tumors to grow in the nervous system, skin, and bone.\nIn 2020, the FDA approved selumetinib capsules for pediatric patients 2 years of age and older with NF1 who have symptomatic, inoperable PN.\nWednesday’s approval was based on adequate bridging between the oral granule and approved capsule formulations in a relative bioavailability (BA) study in healthy adults (Study 89) and exposure matching between the pediatric patient populations in the SPRINT Phase 2 Stratum I study (capsule formulation, ≥ 2 years of age) and the SPRINKLE study (oral granule formulation, ≥ 1 year of age).\nAlso Read: AstraZeneca Lung Cancer Combo Extends Patient Survival By Years In Key Study\nSimilar exposure between the formulations supports extrapolation of efficacy from pediatric patients ≥ 2 years of age to ≥ 1 year of age.\nBased on body surface area, the recommended selumetinib dose is 25 mg/m2 orally twice daily, until disease progression or unacceptable toxicity.\nThe SPRINT trial investigated the efficacy of selumetinib in pediatric patients with NF1 and a measurable target PN that could not be surgically removed without risk of substantial morbidity.\nThe primary efficacy outcome measure was the overall response rate (ORR), which was 66%. All patients had a partial response, and 82% of responders had sustained responses lasting at least 12 months.\nAn independent central review of ORR was performed using the same response criteria and demonstrated an ORR of 44%.\nPrice Action: AZN stock is down 0.33% to $83.96 at the last check Wednesday.\nRead Next:\nPhoto by JHVEPhoto via Shutterstock","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"policyRegulatory","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"}}}