Verastem Oncology Cancer Drug Combination Gets FDA Approval

Dow Jones

2025/05/09

By Josh Beckerman

Verastem Oncology said the Food and Drug Administration approved the combination of avutometinib capsules and defactinib tablets for certain patients with KRAS-mutated recurrent low-grade serous ovarian cancer.

The company expects a combination co-pack will be available in the U.S. in about a week.

The approval was in advance of the June 30 Prescription Drug User Fee Act action date.

Verastem shares were flat at $6.69 prior to a trading halt for pending news.

Write to Josh Beckerman at josh.beckerman@wsj.com

(END) Dow Jones Newswires

By Josh Beckerman

Verastem Oncology said the Food and Drug Administration approved the combination of Avmapki capsules and Fakzynja tablets for certain ovarian-cancer patients.

The company said Thursday it expects the combination co-pack of Avmapki and Fakzynja--or avutometinib and defactinib, respectively--will be available in the U.S. in about a week, marking its transition into a commercial-stage company.

Verastem previously said it was preparing for a mid-2025 launch. The FDA's approval was in advance of the June 30 Prescription Drug User Fee Act action date.

The Needham, Mass., company's shares, flat at $6.69 prior to a trading halt for pending news, spiked to $8 but were recently up 3.5%, to $6.93. The stock is up about 34% this year.

Accelerated approval was based on the Phase 2 RAMP 201 study that demonstrated a 44% overall response rate in patients with KRAS-mutated recurrent low-grade serous ovarian cancer, the company said. Verastem said it is conducting a confirmatory Phase 3 trial, RAMP 301.

Write to Josh Beckerman at josh.beckerman@wsj.com

(END) Dow Jones Newswires

May 08, 2025 14:59 ET (18:59 GMT)

Copyright (c) 2025 Dow Jones & Company, Inc.

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The FDA's approval was in advance of the June 30 Prescription Drug User Fee Act action date. \n</p>\n<p>\n  The Needham, Mass., company's shares, flat at $6.69 prior to a trading halt for pending news, spiked to $8 but were recently up 3.5%, to $6.93. The stock is up about 34% this year. \n</p>\n<p>\n  Accelerated approval was based on the Phase 2 RAMP 201 study that demonstrated a 44% overall response rate in patients with KRAS-mutated recurrent low-grade serous ovarian cancer, the company said. Verastem said it is conducting a confirmatory Phase 3 trial, RAMP 301. \n</p>\n<pre>\n \n</pre>\n<p>\n  Write to Josh Beckerman at josh.beckerman@wsj.com \n</p>\n<pre>\n \n</pre>\n<p>\n  (END) Dow Jones Newswires\n</p>\n<p>\n  May 08, 2025 14:59 ET (18:59 GMT)\n</p>\n<p>\n  Copyright (c) 2025 Dow Jones &amp; Company, Inc.\n</p>\n</font>","source":null,"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>Verastem Oncology Cancer Drug Combination Gets FDA Approval</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; 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The FDA's approval was in advance of the June 30 Prescription Drug User Fee Act action date. \n</p>\n<p>\n  The Needham, Mass., company's shares, flat at $6.69 prior to a trading halt for pending news, spiked to $8 but were recently up 3.5%, to $6.93. The stock is up about 34% this year. \n</p>\n<p>\n  Accelerated approval was based on the Phase 2 RAMP 201 study that demonstrated a 44% overall response rate in patients with KRAS-mutated recurrent low-grade serous ovarian cancer, the company said. Verastem said it is conducting a confirmatory Phase 3 trial, RAMP 301. \n</p>\n<pre>\n \n</pre>\n<p>\n  Write to Josh Beckerman at josh.beckerman@wsj.com \n</p>\n<pre>\n \n</pre>\n<p>\n  (END) Dow Jones Newswires\n</p>\n<p>\n  May 08, 2025 14:59 ET (18:59 GMT)\n</p>\n<p>\n  Copyright (c) 2025 Dow Jones &amp; Company, Inc.\n</p>\n</font>\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4139","symbol_name":"生物科技","start_time":0,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","article_id":"2534525091","we_media_id":"106","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2534525091","pubTimestamp":1746725940,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Dow Jones","introduction":"Dow Jones publishes the world’s most trusted business news and financial information in a variety of media.","home_visible":0,"id":"106","head_image":"https://static.tigerbbs.com/150f88aa4d182df19190059f4a365e99"},"summary":"Verastem Oncology said the Food and Drug Administration approved the combination of avutometinib capsules and defactinib tablets for certain patients with KRAS-mutated recurrent low-grade serous ovarian cancer.The company expects a combination co-pack will be available in the U.S. in about a week.The approval was in advance of the June 30 Prescription Drug User Fee Act action date.Verastem shares were flat at $6.69 prior to a trading halt for pending news.","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4139":"生物科技","VSTM":"Verastem"},"translate_title":"Verastem Oncology癌症药物组合获得FDA批准","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"VSTM":1},"content_text":"By Josh Beckerman \n\n\n \n\n\nVerastem Oncology said the Food and Drug Administration approved the combination of avutometinib capsules and defactinib tablets for certain patients with KRAS-mutated recurrent low-grade serous ovarian cancer. \n\n\n  The company expects a combination co-pack will be available in the U.S. in about a week. \n\n\n  The approval was in advance of the June 30 Prescription Drug User Fee Act action date. \n\n\n  Verastem shares were flat at $6.69 prior to a trading halt for pending news. \n\n\n \n\n\n  Write to Josh Beckerman at josh.beckerman@wsj.com \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n\n \n\n\n  By Josh Beckerman \n\n\n \n\n\n  Verastem Oncology said the Food and Drug Administration approved the combination of Avmapki capsules and Fakzynja tablets for certain ovarian-cancer patients. \n\n\n  The company said Thursday it expects the combination co-pack of Avmapki and Fakzynja--or avutometinib and defactinib, respectively--will be available in the U.S. in about a week, marking its transition into a commercial-stage company. \n\n\n  Verastem previously said it was preparing for a mid-2025 launch. The FDA's approval was in advance of the June 30 Prescription Drug User Fee Act action date. \n\n\n  The Needham, Mass., company's shares, flat at $6.69 prior to a trading halt for pending news, spiked to $8 but were recently up 3.5%, to $6.93. The stock is up about 34% this year. \n\n\n  Accelerated approval was based on the Phase 2 RAMP 201 study that demonstrated a 44% overall response rate in patients with KRAS-mutated recurrent low-grade serous ovarian cancer, the company said. Verastem said it is conducting a confirmatory Phase 3 trial, RAMP 301. \n\n\n \n\n\n  Write to Josh Beckerman at josh.beckerman@wsj.com \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  May 08, 2025 14:59 ET (18:59 GMT)\n\n\n  Copyright (c) 2025 Dow Jones & Company, Inc.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"2","news_tag":"productRelease","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":true,"code":"91000000","status":"200"}}}