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

“Today’s milestone brings us one step closer to providing an effective dual immunotherapy treatment option to adult and pediatric patients with microsatellite instability–high or mismatch repair deficient metastatic colorectal cancer,” said Dana Walker, M.D., M.S.C.E., vice president, Opdivo global program lead, Bristol Myers Squibb. “We look forward to potentially bringing

“The FDA’s clearance, signaling the initiation of our Phase I study for LTZ-301, represents a significant milestone for the company,” said Robert Li, Ph.D., Founder and CEO of LTZ. “We look forward to advancing our lead asset into the clinic to evaluate our myeloid engager approach and its potential as

“Eikon has made remarkable progress in advancing a pivotal-stage clinical pipeline and early-stage development program powered by our single-molecule tracking technology and the deep expertise of our multidisciplinary team. With clinical studies now operating in 28 countries, across 5 continents, we are accelerating the development of much-needed therapies while continuing

AIM CEO Thomas K. Equels stated: “Unlike with many pancreatic cancer studies where accrual can be a major obstacle, we expect to continue to enroll subjects in Phase 2 of DURIPANC at a steady pace.”