Roche has submitted a new drug application (NDA) in China for its oral selective estrogen receptor degrader (SERD), giredestrant, in combination with everolimus. The application is for the treatment of postmenopausal women and men with ESR1-mutated, ER+/HER2- locally advanced or metastatic breast cancer whose disease has progressed on prior endocrine therapy. The submission follows a US application in February 2026. The candidate is designed to block and degrade the estrogen receptor to inhibit cancer growth.

The China submission is based on positive results from the Phase III evERA trial, which demonstrated a significant improvement in progression-free survival (PFS) for the combination compared to the control arm, with the benefit being more pronounced in patients with ESR1 mutations. While giredestrant did not meet the primary endpoint in a separate first-line trial (persevERA), it succeeded in an adjuvant setting study (lidERA).

PharmCube's NextBiopharm® database shows that the competitive landscape for oral SERDs includes three launched products, namely AstraZeneca's fulvestrant, Menarini's elacestrant and Eli Lilly's imlunestrant. Click here to request a free trial for NextBiopharm®.