FDA "Complete Response" On Toremifene Moves The Goal Posts, GTx CEO Says
This article was originally published in Pharmaceutical Approvals Monthly
GTx was taken by surprise with FDA's decision to issue a "complete response" letter for the firm's selective estrogen receptor modulator toremifene 80 mg - a drug whose clinical development program was designed with the agency's help under a Special Protocol Assessment
You may also be interested in...
Getting Past FDA's HALT: Can Amgen Escape New Trial Requirement For Prolia With Data From SRE Studies?
Amgen will attempt to use data culled from its trials of Prolia (denosumab) in reducing skeletal-related events to resolve FDA's questions about the drug's effects in cancer patients, raised in the agency's "complete response" letter on d-mab's use in treating patients with bone loss due to hormone ablation therapy
The next reauthorization of the Special Protocol Assessment process could de-emphasize the idea that an SPA is an "agreement" with FDA
Amgen’s Denosumab, GTx’s Toremifene Keep Pace At ASCO On Prevention Of Bone Fractures In Prostate Cancer Patients
Both firms have October user fee dates for prevention of bone fracture risk in prostate cancer patients on androgen deprivation therapy, and both report favorable incremental data.