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金斯瑞生物科技：海外監管公告: 傳奇生物科技股份有限公司宣佈美國食品藥品管理局腫瘤藥物諮詢委員會對CARVYKTI用於復發或難治性性多發性骨髓瘤患者前線治療的積極意見

GENSCRIPT BIO: OVERSEAS REGULATORY ANNOUNCEMENT: LEGEND BIOTECH CORPORATION ANNOUNCES POSITIVE OPINION FROM THE U.S. FDA ODAC FOR CARVYKTI FOR THE EARLIER TREATMENT OF PATIENT WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA

香港交易所 ·  Mar 17 18:05
Summary by Futu AI
金斯瑞生物科技旗下非全資附屬公司傳奇生物科技於2024年3月15日宣布，其CAR-T療法CARVYKTI（cilta-cel）獲得美國食品藥品管理局（FDA）腫瘤藥物諮詢委員會（ODAC）的積極建議，用於治療至少接受過一線治療的復發或難治性多發性骨髓瘤成人患者。這項建議基於3期CARTITUDE-4研究的數據，並將由FDA進行最終審核。傳奇生物科技的股份在美國納斯達克全球精選市場上市。金斯瑞生物科技提醒股東及潛在投資者注意投資風險，並於買賣證券時審慎行事。CARVYKTI的補充生物製品許可申請（sBLA）目前正在接受FDA審查，預計PDUFA目標日期為2024年4月5日。
金斯瑞生物科技旗下非全資附屬公司傳奇生物科技於2024年3月15日宣布，其CAR-T療法CARVYKTI（cilta-cel）獲得美國食品藥品管理局（FDA）腫瘤藥物諮詢委員會（ODAC）的積極建議，用於治療至少接受過一線治療的復發或難治性多發性骨髓瘤成人患者。這項建議基於3期CARTITUDE-4研究的數據，並將由FDA進行最終審核。傳奇生物科技的股份在美國納斯達克全球精選市場上市。金斯瑞生物科技提醒股東及潛在投資者注意投資風險，並於買賣證券時審慎行事。CARVYKTI的補充生物製品許可申請（sBLA）目前正在接受FDA審查，預計PDUFA目標日期為2024年4月5日。
Legendary Biotechnology, a non-wholly-owned subsidiary of Kingsway Biotechnology, announced on March 15, 2024 that its CAR-T therapy CARVYKTI (cilta-cel) has received positive recommendations from the U.S. Food and Drug Administration's (FDA) Advisory Committee on Oncology (ODAC) for the treatment of relapses of at least first-line therapy or adult patients with difficult-to-treat multiple myeloma. THIS RECOMMENDATION IS BASED ON DATA FROM THE PHASE 3 CARTITUDE-4 STUDY AND WILL BE SUBJECT TO FINAL REVIEW BY THE FDA. Shares of Legendary Biotechnology are listed on Nasdaq Global Select Markets in the United States. Kingsway Biotechnology reminds shareholders and potential investors to be aware of investment risks and to exercise caution when trading securities. CARVYKTI'S SUPPLEMENTAL BIOPRODUCT LICENSE APPLICATION (SBLA) IS CURRENTLY UNDERGOING FDA REVIEW, WITH AN EXPECTED PDUFA TARGET DATE OF APRIL 5, 2024.
Legendary Biotechnology, a non-wholly-owned subsidiary of Kingsway Biotechnology, announced on March 15, 2024 that its CAR-T therapy CARVYKTI (cilta-cel) has received positive recommendations from the U.S. Food and Drug Administration's (FDA) Advisory Committee on Oncology (ODAC) for the treatment of relapses of at least first-line therapy or adult patients with difficult-to-treat multiple myeloma. THIS RECOMMENDATION IS BASED ON DATA FROM THE PHASE 3 CARTITUDE-4 STUDY AND WILL BE SUBJECT TO FINAL REVIEW BY THE FDA. Shares of Legendary Biotechnology are listed on Nasdaq Global Select Markets in the United States. Kingsway Biotechnology reminds shareholders and potential investors to be aware of investment risks and to exercise caution when trading securities. CARVYKTI'S SUPPLEMENTAL BIOPRODUCT LICENSE APPLICATION (SBLA) IS CURRENTLY UNDERGOING FDA REVIEW, WITH AN EXPECTED PDUFA TARGET DATE OF APRIL 5, 2024.
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