GREY:IMVIF - Post by User
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Breakthoroughon Dec 03, 2020 3:36pm
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The data for Pembro 1st BT designation
The data for Pembro 1st BT designationPembrolizumab, an antiPD-1 monoclonal antibody, received FDA's breakthrough therapy designation in January 2013 for the treatment of patients with unresectable or metastatic melanoma that is refractory to ipilimumab and for the treatment of patients who are ipilimumab-nave based on data from 85 patients (ipilimumab-nave,N= 58; refractory to ipilimumab,N= 27) treated with 10 mg/kg of pembrolizumab. The overall response rate (ORR) was 40% (95% confidence interval, 2951) as assessed by central independent review per RECIST v1.1. Duration of response (DOR) ranged from 0.9 to 7.9 months. Breakthrough therapy designation is given for a drug that is intended to treat a serious condition where there is preliminary clinical evidence that the drug may demonstrate substantial improvement on a clinically significant endpoint over available therapies. https://clincancerres.aacrjournals.org/content/23/19/5666