KEYTRUDA had previously met its primary endpoint of progression-free survival in all patients
The partnership will focus on the ongoing SYNERGY-101 randomized Phase 2 trial for first-line
BRAFTOVI in combination with cetuximab and mFOLFOX6 had previously received accelerated approval in December 2024 based on objective response rate (ORR) results
Sugemalimab, developed using CStone’s OmniRat transgenic platform, is a fully human IgG4 monoclonal antibody designed to minimize immunogenicity and toxicity
Prostate cancer is one of the fastest-growing cancers in India, with approximately 37,948 new cases each year
The decision follows compelling data from the AMPLIFY Phase III trial, demonstrating that 77% of patients receiving the Calquence-venetoclax combination were progression-free at three years
BREAKWATER is a Phase 3, randomized, open-label trial testing BRAFTOVI in combination with cetuximab, either alone or with chemotherapy, in patients with untreated BRAF V600E-mutant mCRC
Launched in August 2025, GSK India’s Oncology business is rapidly gaining momentum
The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
Subscribe To Our Newsletter & Stay Updated