Onco-Summaries: Daily Oncology Updates at a Glance
19/10/2026
US FDA approved Jemperli for MSI-H/dMMR locally advanced Rectal Cancer (Ref)
GSK announced US FDA approval of Jemperli (dostarlimab; anti-PD-1) as the first and only immunotherapy for adults with MSI-H/dMMR locally advanced rectal cancer
The approval is based on data from the Phase II AZUR-1 trial
68% of evaluable patients achieved a clinical complete response sustained for at least 12 months (98/144 patients)
76% of evaluable patients (110/144) had no evidence of disease at one year or longer after treatment
No disease recurrence was reported among responders after a median follow-up of more than two years
The safety profile was consistent with previous dostarlimab experience across solid tumors. Most common adverse events included fatigue, rash, diarrhea, and pruritus
The program received FDA Fast Track, Breakthrough Therapy, and Priority Review designations
Quanta Therapeutics receives US FDA Fast Track Designation for QTX3034 in KRAS G12D-mutated CRC (Ref)
Quanta Therapeutics announced that the US FDA has granted Fast Track designation to QTX3034 (G12D-preferring multi-KRAS inhibitor) for the treatment of patients with KRAS G12D-mutated colorectal cancer (CRC) in combination with cetuximab, with or without FOLFOX chemotherapy
The designation follows emerging clinical evidence supporting the development of QTX3034-based combination regimens in this patient population
The company will present updated clinical combination data for QTX3034 at the upcoming ESMO Congress 2026
US FDA accepts UroGen's UGN-103 NDA for recurrent LG-IR-NMIBC, with PDUFA date on June 14, 2027 (Ref)
UroGen Pharma announced that the US FDA has accepted the New Drug Application (NDA) for UGN-103, an investigational mitomycin-based therapy for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
The FDA assigned a PDUFA target action date of June 14, 2027
The NDA is supported by data from the Phase 3 UTOPIA study, which demonstrated a 77.8% complete response (CR) rate at three months. Among patients achieving CR, 94.5% remained event-free at six months based on Kaplan-Meier estimates
The company noted that the efficacy and safety profile of UGN-103 was consistent with results observed in the pivotal ENVISION trial that supported approval of ZUSDURI.
Comments