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NDA 20-449 SE-011 Docetaxel

NDA 20-449 SE-011 Docetaxel. FDA Review. Biostatistics Clara Chu, PhD. Gang Chen, PhD. Biopharmaceutics Safaa Ibrahim PhD Atiq Rahman, PhD. Project Manager Ann Staten, RD Medical Julie Beitz, MD. FDA Review Team. Proposed Indication.

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NDA 20-449 SE-011 Docetaxel

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  1. NDA 20-449 SE-011Docetaxel FDA Review

  2. Biostatistics Clara Chu, PhD. Gang Chen, PhD. Biopharmaceutics Safaa Ibrahim PhD Atiq Rahman, PhD. Project Manager Ann Staten, RD Medical Julie Beitz, MD FDA Review Team

  3. Proposed Indication “for the treatment of patients with locally advanced or metastatic NSCLC after failure of prior chemotherapy”

  4. TAX 317 Docetaxel 100 mg (N= 49) Best Supportive Care (N=51) Docetaxel 75 mg(N=55) Best Supportive Care (N=49) TAX 320 Docetaxel 100 mg(N=125) Docetaxel 75 mg(N=125) Vinorelbine OR Ifosfamide(N=123) The Randomized, Controlled Trials

  5. Trials’ Shared Features • Eligibility/Exclusion Criteria • prior platinum-based chemotherapy required in both studies • prior taxane exposure excluded in TAX 317 only • Primary Endpoint = Survival • Secondary Endpoints

  6. Major Efficacy Issues • Pre-specified vs. Other Analyses • Consistency across studies

  7. Survival - Prespecified Analyses

  8. Survival - Retrospective Analyses

  9. K-M Survival Curves - 75 mg vs. ControlTAX 317 TAX 320 Tax Tax Control BSC S u r v I v I n g S u r v I v I n g

  10. Rate of Survival at One Year - Retrospective Analyses

  11. Historical Perspective • Lack of phase 3 data in the second line setting • First line rates of survival at one year are reported in the range of 18 - 43% for combination regimens (in randomized controlled trials) • Gemcitabine + Cisplatin = 39% • Pactilaxel + Cisplatin = 36% • Vinorelbine + Cisplatin = 35%

  12. Survival: Summary of Review Issues • A significant difference between arms was demonstrated in a pre-specified survival analysis in only one study (TAX317, pooled), in an updated analysis • The analysis of overall survival at the 75 mg dose level favored docetaxel in a retrospective analysis of a single study (TAX317) • Exploratory analyses of rates of one year survival favor docetaxel in both studies • Rates of one year survival are comparable to those reported in the first line setting

  13. Clinical Benefit Parameters

  14. Safety

  15. Summary • Safety • QoL  • Survival 

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