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Accelerated Approvals in Oncology

Accelerated Approvals in Oncology . Richard Pazdur, MD Director, Oncology Drug Products. Oncology Accelerated Approvals. Confirmatory trials: an integral part of a comprehensive drug development strategy Patient population in AA versus population in the confirmatory trials

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Accelerated Approvals in Oncology

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  1. Accelerated Approvals in Oncology Richard Pazdur, MD Director, Oncology Drug Products

  2. Oncology Accelerated Approvals • Confirmatory trials: an integral part of a comprehensive drug development strategy • Patient population in AA versus population in the confirmatory trials • Merits of different trial designs • Single-arm versus randomized trials

  3. Timing of Confirmatory Trials • “Post-marketing studies would usually be underway” • Comprehensive drug development program • Confirmatory trials integrated in the development program

  4. Timing of Confirmatory Trials • Accelerated approval may impact accrual to confirmatory trials • Early design and integration allows further questions to be formulated and answered in confirmatory trials

  5. Timing of Confirmatory Trials • Discussions prior to initiation and during the trial • to ensure adequate accrual • to discuss alternative design • Special protocol assessments • Clear understanding of “due diligence” with periodic review of timeline

  6. Study Population • Refractory setting: unique mechanism? • Confirmatory trials in a less refractory population than initial accelerated approval • Moves the drug to first-line and adjuvant trials • Assists in accrual after accelerated approval • Clinical benefit in approved indication?

  7. Refractory Patient Population • May miss potentially active drug • Progressively more refractory indications • Difficulty in characterizing toxic effects

  8. Trial Designs • Single-arm trials--faster trial completion • Randomized trials allow • Additional endpoints • Completion of clinical benefit in same study • Comparative toxicity

  9. Trial Designs--Randomized trials • Novel cytostatic agents • “Add on” trials • Limitations • Time • Expense

  10. Accelerated Approval: HIV Trials • Two large randomized trials for AA • HIV-RNA at 24 weeks (surrogate) • HIV-RNA in same population, same study at 48 weeks (confirmatory evidence of clinical benefit) • Implications for oncology trial designs

  11. Goals • Constructive dialogue--designing, completing confirmatory trials • Proactive in assessing study design, endpoints, accrual problems, due diligence • Confirmatory trials: an integral part of an AA plan • Recurring public meetings

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