近日，Incyte公司收到了FDA发出了一封完整回复函（CRL），拒绝批准其PD-1抑制剂Zynyz联合铂类化疗用于非小细胞肺癌（NSCLC）一线治疗的补充生物制品许可申请（sBLA）。这也是Zynyz第二次遭拒，2021年7月，因有效性问题，Zynyz治疗肛管鳞状细胞癌（SCAC）二线上市申请被FDA拒批。但这次的CRL与Zynyz的疗效/安全性无关，而是受到了其第三方制造商的波及，具体而言，与...
Source Link近日，Incyte公司收到了FDA发出了一封完整回复函（CRL），拒绝批准其PD-1抑制剂Zynyz联合铂类化疗用于非小细胞肺癌（NSCLC）一线治疗的补充生物制品许可申请（sBLA）。这也是Zynyz第二次遭拒，2021年7月，因有效性问题，Zynyz治疗肛管鳞状细胞癌（SCAC）二线上市申请被FDA拒批。但这次的CRL与Zynyz的疗效/安全性无关，而是受到了其第三方制造商的波及，具体而言，与...
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