林业发展局批准Rucaparib用于BRCA变异的前列腺先列腺癌,改善无进展生存。
FDA approves rucaparib for BRCA-mutated advanced prostate cancer, improving progression-free survival.
美国食品和药物管理局已批准使用rucaparib (Rubraca) 治疗已接受受体导治疗的成年转移性割耐性前列腺癌 (mCRPC) 患者,该癌症与BRCA基因突变有关.
The FDA has granted full approval to rucaparib (Rubraca) for adults with metastatic castration-resistant prostate cancer (mCRPC) linked to BRCA gene mutations who have previously received androgen receptor–directed therapy.
根据TRITOTON3号试验结果,这项批准表明,与标准治疗相比,BRCA改型病人的放射分程无线存活率(11.2个月对6.4个月)大大改善。
The approval, based on the TRITON3 trial, shows rucaparib significantly improved radiographic progression-free survival (11.2 vs. 6.4 months) in BRCA-mutated patients compared to standard treatments.
总体存活率为23.2个月,鲁卡帕里布为21.2个月,控制为21.2个月,尽管在统计上意义不大。
Overall survival was 23.2 months with rucaparib versus 21.2 months with control, though not statistically significant.
该药物现在被批准在化疗前使用,具有常见副作用,包括疲劳、贫血和恶心。
The drug is now approved for use before chemotherapy, with common side effects including fatigue, anemia, and nausea.
这是第一种PARP抑制剂, 展示出优于化疗的无进展性存活率。
It is the first PARP inhibitor to show superior progression-free survival over chemotherapy in this group.