(Total Views: 347)
Posted On: 11/14/2017 11:25:26 PM
Post# of 72448
Bayer pays $400M upfront to buy into Loxo cancer drugs
https://www.fiercebiotech.com/biotech/bayer-p...ncer-drugs
I find this part encouraging for the approval path of Kevetrin.
“When given to 55 patients with 17 types of TRK fusion-positive cancer, the pan-TRK inhibitor achieved an objective response rate of 75%.”
Bayer/Loxo is planning to file for approval after a Phase 2 single-arm open-label trial with 55 patients. No Phase 3 randomized double-blind trial is required. The newly adopted primary endpoint of objective response rate (partial response + complete response) is much faster than the traditional overall survival rate IMO.
Larotrectinib treats patients with defect in the TRK gene, regardless of tumor type. It received breakthrough therapy designation last year. K has the potential to do the same with p53.
https://www.fiercebiotech.com/biotech/bayer-p...ncer-drugs
I find this part encouraging for the approval path of Kevetrin.
“When given to 55 patients with 17 types of TRK fusion-positive cancer, the pan-TRK inhibitor achieved an objective response rate of 75%.”
Bayer/Loxo is planning to file for approval after a Phase 2 single-arm open-label trial with 55 patients. No Phase 3 randomized double-blind trial is required. The newly adopted primary endpoint of objective response rate (partial response + complete response) is much faster than the traditional overall survival rate IMO.
Larotrectinib treats patients with defect in the TRK gene, regardless of tumor type. It received breakthrough therapy designation last year. K has the potential to do the same with p53.
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