Abraxis: Clear Regulatory Pathway for Abraxane in Lung Cancer

Abraxis has reached an agreement with the FDA under the special protocol assessment process for a pivotal trial involving Abraxane. The Phase III non-small cell lung cancer trial will investigate this albumin-bound paclitaxel reformulation in the first-line setting. The agreement provides a clear pathway for horizontal expansion for Abraxane if the trial endpoints are achieved.

The Phase III trial aims to randomize 1,000 previously untreated stage IIIb/IV non-small cell lung cancer (NSCLC) patients to receive carboplatin and either Abraxane or conventional paclitaxel. The primary endpoint of this study will be overall response rate and enrollment of this trial will begin immediately.

The FDA’s special protocol assessment (SPA) process was implemented in November 1997 under the Prescription Drug User Fee Act. This process establishes a binding agreement with the FDA that the Phase III trial protocol design, clinical endpoints, planned conduct and statistical analyses are acceptable to support regulatory approval. Given this advantageous agreement, and assuming the clinical endpoints are reached, a clear pathway for an additional approved indication for Abraxane has now been set.

Developed by Abraxis BioScience, Abraxane is a nanoparticle, albumin-bound reformulation of paclitaxel that does not require formulation in Cremophor and alcohol. This novel formulation eliminates certain toxicities that are associated with standard paclitaxel and allows higher dose of paclitaxel to be administered.

Abraxane was approved by the FDA in January 2005 for the treatment of metastatic breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. It was also accepted for review by the EMEA for this indication in September 2006. In May 2006, AstraZeneca announced that it would co-promote Abraxane in the US. Under the agreement, AstraZeneca also has a right of first offer to co-promote the product outside the US.

NSCLC accounts for over 80% of the 1.2 million new cases of lung cancer diagnosed each year. In spite of the use of standard chemotherapy as the first-line treatment option, less than 5% of people with advanced NSCLC survive for five years after diagnosis and most die within 12 months. Abraxane may offer a significant improvement in patient survival, and goes some way to alleviate some of the high unmet needs in NSCLC. Moreover, uptake of Abraxane in this increasingly crowded market is likely to be maximized with the backing of a major oncology player like AstraZeneca. Importantly however, Abraxane will still have to compete with cheaper standard generic paclitaxel in some of the more cost-conservative markets.