Signals
2FDA accelerated-approval reform is changing oncology evidence requirements
Post-Aduhelm reform of the accelerated-approval pathway has tightened expectations for confirmatory trial design, enrolment timing, and surrogate-endpoint validity. Oncology programs targeting accelerated approval are seeing the practical effect first.
EU market-access pathway for BCMA bispecifics is bifurcating
Coverage decisions across the major EU markets for the BCMA bispecific class in relapsed-refractory multiple myeloma are diverging on use-setting, prior-line requirements, and post-marketing evidence demands. The variance is wider than the underlying clinical evidence supports.
Explained
3How combination regimens are restructuring late-line oncology trial design
Late-line oncology trials are increasingly testing combination regimens rather than single-agent comparisons. The trial-design conventions, the regulatory framework, and the commercial implications of combination-as-standard are different enough from single-agent design that cross-functional teams need to understand the shift.
How to read a modern phase 3 oncology readout: hazard ratios, crossover and what regulators care about
Phase 3 oncology trial readouts have a vocabulary, a set of conventions, and a regulatory frame that the headline numbers obscure. This is a plain-language guide to the parts of the readout that decide approval, label and reimbursement.
Why 'tumor-agnostic' approvals are reshaping reimbursement reviews
When a drug is approved for a molecular target across tumor types rather than for one cancer, the HTA review framework has to evaluate efficacy across heterogeneous indications with different unmet needs, comparators, and standard-of-care benchmarks. That has practical consequences for access timelines.