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Drug Combo Meets NSCLC Milestone


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Drug Combo Meets NSCLC Milestone

By Michael Smith, North American Correspondent, MedPage Today

Published: March 20, 2010

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Nanoparticle albumin-bound paclitaxel (Abraxane) met a key milestone in a non-small cell lung cancer clinical trial, the drug's maker said.

In a multicenter phase III study of 1,052 patients, the drug showed a significant improvement in overall response rate, compared with solvent-based paclitaxel (Taxol), according to Abraxis BioScience.

The data from the trial are to be submitted as a late-breaking abstract for the June meeting of the American Society of Clinical Oncology in Chicago, the Los Angeles-based company said in a statement.

The study compared both forms of the drug, in combination with carboplatin, for first-line treatment of patients with advanced non-small cell lung cancer. The response rate was assessed by independent radiologist review, the company said.

Under a special protocol assessment with the FDA, the study's design, clinical endpoints, and methods of statistical analysis were previously agreed upon. The FDA agreed that a statistically superior response rate for the protein-bound paclitaxel and carboplatin combination would allow a supplemental new drug application to go forward.

The company said it expects to file such an application in 2011.

If approved, it would be the second indication for the protein-bound form of paclitaxel. The FDA okayed it in 2005 for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy.

The advantage of the drug is that the paclitaxel-containing nanoparticles use endogenous albumin transport mechanisms to concentrate in tumors, delivering higher concentrations than the usual form of paclitaxel.

The drug is also being investigated for the treatment of pancreatic and gastric cancer, malignant melanoma, and expanded indications for metastatic breast cancer.

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