EMA approves WELIREG® (belzutifan) for advanced clear cell RCC that progressed following a PD(L)-1 inhibitor and at least two VEGF therapies

“The approval of WELIREG in the EU introduces the first and only systemic treatment option for adult patients with certain VHL disease-associated tumors for whom localized procedures are unsuitable, and offers a new option for adult patients with advanced clear cell renal cell carcinoma that progressed following a PD-1 or PD-L1 inhibitor and at least two VEGF targeted therapies,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “This is an important moment, and we are pleased that WELIREG, a first-in-class HIF-2α inhibitor, can now potentially help these patients in need.”

Share:

More News

Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, said: “The positive CHMP opinion for the sqNSCLC indication marks another important milestone in serplulimab’s regulatory journey in Europe and brings the product one step closer to achieving comprehensive coverage of first-line lung cancer treatment indications in the EU.

“Many solid tumors remain difficult to treat despite advances in immunotherapy,” said Rustam Esanov, CEO and co-founder of Reprogram Biosciences. “Our approach is differentiated by its reprogramming of the tumor itself into a site of immune activation, rather than relying on exogenous immune cells or broadly acting systemic agents.”

Mabwell, an innovation-driven biopharmaceutical company with a fully integrated industry chain, today announced that the first patient has been dosed in a Phase III clinical trial evaluating its novel Nectin-4-targeting ADC (Bulumtatug Fuvedotin, or BFv, R&D code: 9MW2821) for the treatment of locally advanced or metastatic triple-negative breast cancer (TNBC).