金斯瑞生物科技(01548.HK):傳奇生物向歐洲藥品管理局提交上市許可申請 以尋求批准將西達基奧侖賽用於治療復發或難治性多發性骨髓瘤患者
格隆匯4月30日丨金斯瑞生物科技(01548.HK)公吿,公司非全資附屬公司傳奇生物科技股份有限公司於2021年4月30日宣佈向歐洲藥品管理局提交了上市許可申請(MAA),以尋求批准將西達基奧侖賽(cilta-cel)用於治療復發和╱或難治性多發性骨髓瘤患者。
cilta-cel是一種在研的靶向B細胞成熟抗原(BCMA)嵌合抗原受體T細胞(CAR-T)療法,用於治療多發性骨髓瘤。上市許可申請基於在美國血液學會(ASH)2020年年會上公佈的1b/2期CARTITUDE-1研究的積極結果,由傳奇生物cilta-cel的合作伙伴—Janssen-CilagInternational N.V.(Janssen Biotech Inc.的附屬公司)向EMA提交。
上市申請提交證明了集團從CARTITUDE-1研究中看到的具有前景的結果,該結果顯示了cilta-cel在治療既往接受過多次治療並亟需治療方案的多發性骨髓瘤患者方面的療效和安全性。集團為與Janssen合作而感到自豪,並期待在加速評估後將此個性化治療帶給歐盟的患者。
EMA人用藥品委員會(CHMP)批准了對上市許可申請的加速評估。當確定某藥品具有重大公共衞生意義和治療創新性,並且可以顯着減少評估上市許可申請的審查時間時,CHMP會批准進行加速評估。cilta-cel此前獲得EMA優先藥物(PRIME)認定。目前,美國食品和藥物管理局(FDA)正在審查基於CARTITUDE-1研究的尋求批准cilta-cel的生物製品許可申請(BLA)。
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