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Physician Assessment of Peripheral Neuropathy NCI CTC Grade—Cumulative Dose

NE-7. Physician Assessment of Peripheral Neuropathy NCI CTC Grade—Cumulative Dose. Abraxane (N = 229) Taxol (N = 225) P -value = 0.250. NCI CTC Grade. Source: NDA Addendum. Note: P -value from treatment by dose interaction effect from the following repeated measures model:

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Physician Assessment of Peripheral Neuropathy NCI CTC Grade—Cumulative Dose

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  1. NE-7 Physician Assessment of Peripheral NeuropathyNCI CTC Grade—Cumulative Dose Abraxane (N = 229) Taxol (N = 225) P-value = 0.250 NCI CTC Grade Source: NDA Addendum. Note: P-value from treatment by dose interaction effect from the following repeated measures model: Y = Treatment Patient (Treatment) Dose Treatment *Dose.

  2. NE-8 Patient Assessment of Peripheral NeuropathyTotal Score by Cumulative Dose Abraxane (N = 229) Taxol (N = 225) P-value = 0.202 Total Score Source: NDA Addendum. Note: P-value from treatment by dose interaction effect from the following repeated measures model: Y = Treatment Patient (Treatment) Dose Treatment *Dose.

  3. NE-9 Patients with Grade 3 Sensory Neuropathy: Time to Improvement to Grade 1 or 2 (Based on AE Data) Abraxane (N = 24) Taxol (N = 5) Censored P-value = 0.028 Proportion Not Improved Source: NDA Addendum. Note: P-value from log-rank test.

  4. RG-2 Examples of Drugs Approved as 505(b)(2) NDAs

  5. PK-3 CA008: Summary of Paclitaxel PharmacokineticParameters for Abraxane and Taxol Source: Abraxane NDA

  6. PK-11 Biodistribution of Abraxane andTaxol Are Similar

  7. TI-1 Time to Progression Analysis for Phase 3 Study • The following two analyses of TTP have been conducted: • TTP based on all on-therapy Investigator response assessments. • post-approval commitment, June 2005 • TTP based on the Independent Radiology Laboratory (IRL) response assessments and Investigator response assessments • labeling supplement, July 2006 • It makes use of all available response assessments including the IRL assessments for cycles 1–6 and all Investigator assessments, and • It uses a conservative approach through cycles 1–6 by selecting the earliest date of progression between the IRL assessments and Investigator assessments • These TTP data are currently under review with the FDA

  8. TI-2 Abraxane (N = 229) Taxol (N = 224) P-value = 0.002 HR = 0.726 Abraxane Prolonged Time to Tumor ProgressionCA012: Secondary Endpoint Time to Tumor Progression Time to Tumor Progression Abraxane (N = 233) Taxol (N = 227) P-value = 0.002 Hazard Ratio = 0.721 Proportion Not Progressed Investigator assessmentJune 2005(NDA Post marketing commitment) Investigator assessment+Independent radiology reviewJuly 2006(Labeling supplement) Note: P-value from log-rank test.

  9. TI-3 Time to Disease ProgressionBlindedIndependent Radiology Laboratory Assessment Proportion not Progressed Abraxane (N = 215) Taxol (N = 214) P-value = 0.003 HR = 0.519 Source data on file Abraxis BioScience Note: P-value from log-rank test.

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