Roche’s Lunsumio VELO–Polivy combo moves closer to FDA decision after strong lymphoma trial results
The safety profile of the Lunsumio and Polivy combination was consistent with the known profiles of the individual study medicines
The safety profile of the Lunsumio and Polivy combination was consistent with the known profiles of the individual study medicines
The FDA has granted Priority Review, setting a target decision date of 9 October 2026, potentially accelerating access to a new treatment option for a subset of patients with high-risk colon cancer characterized
The agreement underscores Roche’s commitment to advancing innovative therapies for blood cancers and other serious diseases
The filing is backed by Phase III data from the lidERA Breast Cancer study
The company announced that its Phase III FENhance 1 and 2 studies both met their primary endpoints
The Phase III METEOROID study met its primary endpoint, with ENSPRYNG cutting the risk of a first relapse by 68% compared to placebo in adults and adolescents
Giredestrant shows promise despite missing primary goal
Gazyva/Gazyvaro outperformed placebo across all key and secondary endpoints
The company announced positive topline data from the Phase II ZUPREME-1 trial
Fenebrutinib has the potential to become the first and only high-efficacy oral, brain-penetrant treatment for both RMS and PPMS, showing a profound benefit on relapsing and progressive disease biology
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