FDA批准第一个抗PD1单抗？

加速批准主要是基于 KEYNOTE-001 phase1b临床研究的结果?临床2,3期都未开始。似乎有不少PD-1的单抗药物在III期吧，这应该不是最快的，也不是第一个吧？
KEYTRUDA is the first anti-PD-1 (programmed death receptor-1) therapy approved in the United States and received FDA’s Breakthrough Therapy designation for advanced melanoma, which was granted based on the significance of early study findings and the unmet medical need. For the recommended 2 mg/kg dose based on data in 89 patients, the overall response rate was 24 percent (95% CI: 15, 34), with one complete response and 20 partial responses (21/89). At the time of analysis, 86 percent (18/21) of patients with objective responses had ongoing responses with durations ranging from 1.4+ to 8.5+ months, including eight patients with ongoing responses of 6 months or longer. Fourteen percent (3/21) had progression of disease 2.8, 2.9, and 8.2 months after initial response.

加速批准主要是基于 KEYNOTE-001 phase1b临床研究的结果?临床2,3期都未开始。似乎有不少PD-1的单抗药物在III期吧，这应该不是最快的，也不是第一个吧？

FDA的加速批准可不是主要是基于 KEYNOTE-001 phase1b
他的二期是做完了的，三期我忘了

FDA的加速批准可不是主要是基于 KEYNOTE-001 phase1b
他的二期是做完了的，三期我忘了
The approval of KEYTRUDA was based on data from a multi-center, open-label, randomized, dose-comparative study cohort of the ongoing KEYNOTE-001 Phase 1b trial in patients with unresectable or metastatic melanoma and progression of disease. Key eligibility criteria included prior treatment with ipilimumab (two or more doses at 3 mg/kg or higher) and a BRAF or MEK inhibitor, if BRAF V600 mutation positive; and disease progression within 24 weeks following the last dose of ipilimumab. Patients were randomized to receive 2 mg/kg (n=89) or 10 mg/kg (n=84) of KEYTRUDA every 3 weeks until unacceptable toxicity or disease progression. The major efficacy outcome measures were confirmed overall response rate as assessed by blinded independent central review using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and duration of response. Tumor response was assessed every 12 weeks.