Study Questions Whether Patients Understand Risks of Unproven Accelerated-Approval Cancer Drugs

• Many cancer drugs get accelerated FDA approval before definitive proof of benefit • 85% of accelerated approvals are for cancer drugs; only 43% have proven benefits within 5 years • Researchers question if patients understand uncertainty around these unproven drugs • Doctors should carefully explain limitations of accelerated approval drugs
• FDA has new authority to withdraw accelerated approvals if companies don't provide evidence