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Accelerated Approvals in Oncology A 10 - Year Experience

Accelerated Approvals in Oncology A 10 - Year Experience. Purpose. Review past accelerated approvals Discuss current progress of associated phase 4 commitments Solicit input for improving the process. Outline. Oncology product AA from CDER and CBER Regulatory background

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Accelerated Approvals in Oncology A 10 - Year Experience

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  1. Accelerated Approvals in Oncology A 10 - Year Experience

  2. Purpose • Review past accelerated approvals • Discuss current progress of associated phase 4 commitments • Solicit input for improving the process

  3. Outline • Oncology product AA from CDER and CBER • Regulatory background • Approvals based on controlled trials lacking a concurrent comparator • Approvals based on randomized studies • Converted indications • Issues for the committee

  4. Overview • 19 NDAs or BLAs for new treatment indications (involving 16 drugs) • Seven within l8 months of meeting invitation • Subsequent full approval in 4 • Remaining 8 to be presented over next two days

  5. Regulatory Basis - Subpart H (21CFR 314) • For serious or life-threatening diseases • Where the drug appears to provide benefit over available therapy • Approval based on a surrogate that is reasonably likely to predict clinical benefit

  6. 21CFR314 (continued) • Subject to the requirement that the applicant verify and describe benefit • Post-marketing studies would usually be underway • The applicant shall carry out such studies with due diligence

  7. Endpoints in Oncology • Survival and improvement in patient reported symptoms considered clinical benefit • Objective Response Rate and Time to Progression usually viewed as surrogates • RR representing benefit: relatively non-toxic products such as hormonal therapies or some biologics

  8. Approvals (no concurrent comparator)

  9. Approvals (no concurrent comparator)

  10. Approvals(no concurrent comparator)

  11. Approvals(randomized trials)

  12. Approvals(randomized trials)

  13. Endpoints Utilized • No concurrent comparator : ORR • Randomized setting : Cytologic response, number of polyps, ORR, TTP, DFS, LVEF ; CHF

  14. Uncertainty of Benefit to Ultimate Outcome • Amifostine (Ethyol) • Dexrazoxane (Zinecard) • Anastrozole (Arimidex) • Imatinib mesylate (Gleevec) • first-line CML

  15. Timing of Confirmatory Trials Converted Indications

  16. Sponsor Presentations

  17. Protocol Issues • Has accrual been satisfactory ? • If not, what strategies can address this ? • Have changing circumstances impeded the conduct of a planned trial ? • If so, what alternative designs should be contemplated ?

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