Physician Assessment of Peripheral Neuropathy NCI CTC Grade—Cumulative Dose Source: NDA Addendum. Note: P-value from treatment by dose interaction effect.

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Presentation transcript:

Physician Assessment of Peripheral Neuropathy NCI CTC Grade—Cumulative Dose 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. Abraxane (N = 229) Taxol (N = 225) P-value = NCI CTC Grade NE-7

Patient Assessment of Peripheral Neuropathy Total Score by Cumulative Dose 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. Abraxane (N = 229) Taxol (N = 225) P-value = Total Score NE-8

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

Examples of Drugs Approved as 505(b)(2) NDAs RLD505(b)(2) Product Taxol ® (paclitaxel) Injection (BMS) Abraxane ® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) (Abraxis BioScience, Inc.) Change to an approved drug (different excipient) Genotropin (somatropin for injection) (Pfizer) Omnitrope™ (somatropin [rRNA origin]) for injection (Sandoz, Inc.) Change to an approved drug (follow-on protein/recombinant source) Premarin (conjugated estrogen tablets, USP) (Wyeth) Cenestin tablets (estrogens, conjugated synthetic A) (Duramed) Change to an approved drug (immediate release tablet/synthetic estrogens) RG-2

CA008: Summary of Paclitaxel Pharmacokinetic Parameters for Abraxane and Taxol Source: Abraxane NDA PK-3

Biodistribution of Abraxane and Taxol Are Similar PK-11

Time to Progression Analysis for Phase 3 Study  The following two analyses of TTP have been conducted: 1.TTP based on all on-therapy Investigator response assessments. post-approval commitment, June 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 TI-1

Abraxane Prolonged Time to Tumor Progression CA012: Secondary Endpoint Note: P-value from log-rank test. Abraxane (N = 229) Taxol (N = 224) P-value = HR = Proportion Not Progressed Abraxane (N = 233) Taxol (N = 227) P-value = Hazard Ratio = Investigator assessment June 2005 (NDA Post marketing commitment) Time to Tumor Progression Investigator assessment + Independent radiology review July 2006 (Labeling supplement) TI-2

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