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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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fda review team
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

Proposed Indication

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

the randomized controlled trials
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
trials shared features
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
major efficacy issues
Major Efficacy Issues
  • Pre-specified vs. Other Analyses
  • Consistency across studies
k m survival curves 75 mg vs control tax 317 tax 320
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

historical perspective
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%
survival summary of review issues
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
summary
Summary
  • Safety
  • QoL 
  • Survival 
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