# Presentation: 693304

## 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 = 0.250**

**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 = 0.202**

**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 = 0.028**

**Proportion Not Improved**

**NE-9**

## Examples of Drugs Approved as 505(b)(2) NDAs

| RLD | 505(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) | OmnitropeTM (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

**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:**
**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**

**TI-1**

## Abraxane Prolonged Time to Tumor ProgressionCA012: Secondary Endpoint

**Note: *****P*****-value from log-rank test.**

**Proportion Not Progressed**

**Abraxane (N = 233)**
**Taxol (N = 227)**
***P*****-value = 0.002**
**Hazard Ratio = 0.721**

**Investigator assessment****June 2005****(NDA Post marketing commitment)**

**Time to Tumor Progression**

**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 = 0.003**
**HR = 0.519**

**Proportion not Progressed**

**TI-3**