WELIREG (belzutifan) + KEYTRUDA (pembrolizumab) or KEYTRUDA QLEX
Adjuvant treatment of clear cell renal cell carcinoma at increased risk of recurrence · Adults at intermediate-high or high risk after nephrectomy, or after nephrectomy and resection of metastatic lesions
MRK · Merck
监管认定
完整时间线
4 个里程碑FDA approved WELIREG plus KEYTRUDA
FDA approved belzutifan with pembrolizumab or KEYTRUDA QLEX as adjuvant treatment for adults with clear cell renal cell carcinoma at increased risk of recurrence after surgery.
FDA — WELIREG plus KEYTRUDA adjuvant RCC approval↗FDA accepted the supplemental applications with Priority Review
FDA accepted the WELIREG sNDA and KEYTRUDA/KEYTRUDA QLEX sBLAs, assigned a June 19 action date, and Merck presented detailed LITESPARK-022 results showing a 28% reduction in recurrence or death.
Merck — LITESPARK-022 results and FDA Priority Review↗LITESPARK-022 met its primary endpoint
The pivotal trial demonstrated a statistically significant improvement in disease-free survival for WELIREG plus KEYTRUDA compared with KEYTRUDA alone.
Merck — LITESPARK-022 regulatory and clinical milestone summary↗Phase 3 LITESPARK-022 study started
The randomized trial began evaluating adjuvant belzutifan plus pembrolizumab after nephrectomy in patients with clear cell renal cell carcinoma.
ClinicalTrials.gov — LITESPARK-022 study record (NCT05239728)↗相关新闻
暂无相关新闻。