Clinical Scorecard: Reevaluating the Standards for Approving New Cancer Therapies

At a Glance

Key Highlights

• Accelerated Approval Program allows drugs to be approved based on surrogate endpoints.
• Most anticancer therapies do not show benefit in overall survival or quality of life within 5 years of approval.
• Patients prioritize understanding treatment impact on survival and quality of life.
• Only 60% of drugs approved between 2013 and 2022 included patient-reported outcome measures.
• FDA's focus on faster approvals may compromise the robustness of clinical evidence.

Guideline-Based Recommendations

Diagnosis

Management

• Measurement of patient-reported quality of life should be required for drugs pursuing expedited approval.

Monitoring & Follow-up

Risks

Patient & Prescribing Data

Patients are willing to accept trade-offs between approval speed and clinical uncertainty when no alternatives exist.

Clinical Best Practices

• Ensure patients are informed about the nature of expedited approvals and the robustness of supporting evidence.

Related Resources & Content

• Forrest et al study
• FDA accelerated approval program