Drugs & Targets

Drugs & Targets

FDA grants fast track designation for enobosarm in AR+ ER+ HER2- metastatic breast cancer

FDA granted Fast Track designation to the phase III registration program for enobosarm, a selective androgen receptor targeting agonist, for the treatment of androgen receptor positive, estrogen receptor positive, human epidermal growth factor receptor 2 negative (AR+ER+HER2-) metastatic breast cancer patients who have shown previous disease progression on a nonsteroidal AI, Faslodex (fulvestrant), and CDK 4/6 inhibitor therapy, and who have AR% nuclei staining ≥40% in breast cancer tissue (third-line metastatic setting).
Drugs & TargetsFree

EU CHMP adopts positive opinion for Keytruda as adjuvant therapy in RCC following surgery

The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending approval of  Keytruda (pembrolizumab), an anti-PD-1 therapy, as monotherapy for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.