Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- Jul 21
- 1 min read
13/07/2026
FDA accepts BMS’s NDA for mezigdomide in relapsed/refractory Multiple Myeloma (Ref)
The US FDA has accepted Bristol Myers Squibb’s New Drug Application (NDA) for mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) for relapsed/refractory multiple myeloma (RRMM)
A Prescription Drug User Fee Act (PDUFA) target action date has been set for May 13, 2027
Filing was supported by SUCCESSOR-2 Phase 3 trial results:
MeziKd significantly improved progression-free survival (PFS): median 18.0 months vs. 8.3 months with Kd alone (HR: 0.48; p<0.0001)
Represents a 52% reduction in risk of progression or death
Safety profile consistent with prior mezigdomide studies and known profiles of regimen agents
GSK’s dostarlimab (aPD-1) delivers sustained complete responses in dMMR/MSI-H rectal cancer (Ref)
GSK reported positive interim results from its Phase II AZUR-1 trial, showing dostarlimab produced sustained clinical complete responses in patients with dMMR/MSI-H locally advanced rectal cancer. The primary endpoint was met, with sustained clinical complete response at 12 months (cCR12)
Some patients showed no detectable cancer one year or more after treatment
Safety profile consistent with prior data across solid tumors
Dostarlimab has received both Breakthrough Therapy and Fast Track designations from the US Food and Drug Administration (FDA) in this setting
Interim data will be shared with regulators, including accelerated review in the US
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