GSK said its Jemperli (dostarlimab) cleared the primary goal in an AZUR-1 Phase 2 setting for dMMR/MSI-H locally advanced rectal cancer, teeing up an FDA filing. The company plans to share data with regulators and pursue a path that uses complete response outcomes from a single-arm study. Separately, the FDA’s evolving approach to evidence requirements for drug approvals remains under scrutiny, with researchers warning that a “one pivotal trial” policy could increase the chance of ineffective medicines reaching the market. That debate matters for oncology developers because many programs rely on accelerating pathways and endpoint strategies designed to fit regulatory expectations. For the field, GSK’s move underscores how immunotherapy evidence in smaller molecularly defined indications can translate into submissions—while the policy debate signals regulators and stakeholders are still actively negotiating the strength of clinical proof needed in practice.