Lilly’s sofetabart mipitecan gets FDA Breakthrough Therapy designation for ovarian cancer

Lilly’s sofetabart mipitecan gets FDA Breakthrough Therapy designation for ovarian cancer

Eli Lilly and Company has received Breakthrough Therapy designation from the U.S. Food and Drug Administration for its investigational antibody-drug conjugate, sofetabart mipitecan, also known as LY4170156. The designation applies to adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received prior treatment with bevacizumab and mirvetuximab soravtansine. The novel […]

AstraZeneca, Daiichi Sankyo push Enhertu into early breast cancer with new FDA nod

AstraZeneca, Daiichi Sankyo push Enhertu into early breast cancer with new FDA nod

AstraZeneca PLC and Daiichi Sankyo’s HER2-directed antibody-drug conjugate Enhertu (trastuzumab deruxtecan) has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration for use in patients with HER2-positive early breast cancer who have residual invasive disease following neoadjuvant treatment and are at high risk of recurrence. The designation is based on positive results […]

PADCEV plus Keytruda meets survival endpoints in cisplatin-eligible bladder cancer patients

PADCEV plus Keytruda meets survival endpoints in cisplatin-eligible bladder cancer patients

Astellas Pharma Inc. and Pfizer Inc. have announced that their antibody-drug conjugate PADCEV (enfortumab vedotin), in combination with the PD-1 inhibitor pembrolizumab (marketed as Keytruda by Merck), met key survival endpoints in the Phase 3 EV-304 trial. In cisplatin-eligible patients with muscle-invasive bladder cancer (MIBC), the combination significantly improved both event-free survival and overall survival […]

Can Biohaven’s BHV-1510 avoid the safety pitfalls of existing Trop2 ADCs in solid tumors?

Can Biohaven’s BHV-1510 avoid the safety pitfalls of existing Trop2 ADCs in solid tumors?

Biohaven Ltd. presented updated Phase 1 clinical data on BHV-1510, its next-generation Trop2-targeting antibody-drug conjugate, at the 2025 European Society for Medical Oncology (ESMO) Immuno-Oncology Congress in London. The results, derived from a heavily pretreated population with advanced or metastatic solid tumors, showed encouraging response rates across non-small cell lung cancer, endometrial cancer, and urothelial […]