泼尼松龙

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国家药监局:批准利普卓联合疗法用于治疗BRCA突变前列腺癌患者
Guang Zhou Ri Bao· 2025-07-31 09:01
Core Viewpoint - AstraZeneca and Merck have announced that the National Medical Products Administration (NMPA) has approved the use of the PARP inhibitor Olaparib in combination with Abiraterone and Prednisone or Prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer carrying germline or somatic BRCA mutations [1] Group 1: Approval and Clinical Data - The NMPA's approval is based on the results of the PROpel Phase III trial, which included global and Chinese cohort subgroup analyses [1] - Data from the global cohort of patients with BRCA mutations showed a significant improvement in imaging progression-free survival with the combination of Olaparib and Abiraterone compared to Abiraterone monotherapy [1] - Although the sample size of the Chinese cohort was small and interpretation was limited, the study data also indicated improvements consistent with global cohort trends, with no new safety issues identified [1] Group 2: Expert Commentary - Professor Ye Dingwei, a leading researcher of the PROpel study in China, emphasized that patients with BRCA mutation metastatic castration-resistant prostate cancer have poor prognoses and unmet clinical needs [1] - He stated that the PROpel study results allow for earlier use of Olaparib in treatment, improving patient outcomes and highlighting the potential of this innovative therapy to become a new treatment standard [1] Group 3: Company Strategy - Dr. He Jing, AstraZeneca's Global Senior Vice President and Head of Global R&D in China, expressed excitement over the PROpel study results and indicated that the company will continue to leverage both in-house research and external collaborations to enrich its pipeline for the benefit of more cancer patients [1]
默沙东:利普卓联合疗法在华获批用于治疗前列腺癌患者
Zheng Quan Shi Bao Wang· 2025-07-31 06:19
Core Viewpoint - Merck has received approval from the National Medical Products Administration of China for its PARP inhibitor, Olaparib, in combination with Abiraterone and Prednisone or Prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) carrying germline or somatic BRCA mutations (gBRCAm or sBRCAm) [1] Group 1 - The approval of this combination therapy will provide advanced treatment options for more prostate cancer patients [1]
默沙东:利普卓 (奥拉帕利)联合阿比特龙和泼尼松或泼尼松龙在华获批用于治疗携带胚系或体细胞BRCA突变的转移性去势抵抗性前列腺癌成人患者
Mei Ri Jing Ji Xin Wen· 2025-07-31 06:15
Group 1 - Merck announced that the National Medical Products Administration of China has officially approved its PARP inhibitor, Lapatinib (Olaparib), in combination with Abiraterone and Prednisone or Prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) carrying germline or somatic BRCA mutations (gBRCAm or sBRCAm) [1]
默沙东:利普卓®(奥拉帕利)联合阿比特龙和泼尼松或泼尼松龙在华获批用于治疗携带胚系或体细胞BRCA突变的转移性去势抵抗性前列腺癌成人患者
news flash· 2025-07-31 06:07
Core Viewpoint - Merck has received approval from the National Medical Products Administration of China for its PARP inhibitor, Lynparza (olaparib), in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) carrying germline or somatic BRCA mutations [1] Group 1 - The approval is specifically for adult patients with mCRPC who have either germline BRCA mutations (gBRCAm) or somatic BRCA mutations (sBRCAm) [1] - This combination therapy represents a significant advancement in the treatment options available for mCRPC patients in China [1] - The collaboration between Merck and AstraZeneca highlights the ongoing efforts to enhance cancer treatment through innovative drug combinations [1]