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Home » Drug Information » FDA Approved Drugs » 2012
Medical Areas: Oncology | Pulmonary/Respiratory Diseases | Family Medicine

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Abraxane (paclitaxel protein-bound particles for injectable suspension)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Celgene
Approval Status: Approved October 2012
Treatment Area: non-small cell lung cancer

General Information

Abraxane (paclitaxel protein-bound particles for injectable suspension) is an intravenous nanoparticle, albumin-bound formulation of paclitaxel, a cancer chemotherapy, that is protein-stable and Cremophor-free. It was designed to deliver a greater amount of chemotherapy to cancer cells with fewer side effects.

Abraxane is specifically indicated for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.

Abraxane is supplied as a solution for intravenous injection. The recommended dose is 100 mg/m2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. The recommended dose of carboplatin is AUC = 6 mg min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of Abraxane administration.

Clinical Results

FDA Approval
The FDA approval of Abraxane for non-small cell lung cancer was based on a multicenter, randomized, open-label conducted in 1052 chemonaive patients with Stage IIIb/IV non-small cell lung cancer. The trial was designed to compare Abraxane in combination with carboplatin to paclitaxel injection in combination with carboplatin as first-line treatment. Abraxane was administered as an intravenous infusion over 30 minutes at a dose of 100 mg/m2 on Days 1, 8, and 15 of each 21-day cycle. Paclitaxel injection was administered as an intravenous infusion over 3 hours at a dose of 200 mg/m2, following premedication. In both treatment arms carboplatin at a dose of AUC = 6 mg min/mL was administered intravenously on Day 1 of each 21-day cycle after completion of Abraxane/paclitaxel infusion. Treatment was administered until disease progression or development of an unacceptable toxicity. The primary efficacy outcome was overall response rate. Subjects in the Abraxane/carboplatin arm had a statistically significantly higher overall response rate compared to those in the paclitaxel injection/carboplatin arm (33% versus 25%). There was no statistically significant difference in overall survival between the two study arms.

Side Effects

Adverse events associated with the use of Abraxane when used in combination with carboplatin for non-small cell lung cancer may include, but are not limited to, the following:

  • anemia
  • neutropenia
  • thrombocytopenia
  • alopecia
  • peripheral neuropathy
  • nausea
  • fatigue

Mechanism of Action

Abraxane is a microtubule inhibitor that promotes the assembly of microtubules from tubulin dimers and stabilizes microtubules by preventing depolymerization. This stability results in the inhibition of the normal dynamic reorganization of the microtubule network that is essential for vital interphase and mitotic cellular functions. Paclitaxel induces abnormal arrays (or bundles) of microtubules throughout the cell cycle and multiple asters of microtubules during mitosis.

Literature References

Socinski MA, Bondarenko I, Karaseva NA, Makhson AM, Vynnychenko I, Okamoto I, Hon JK, Hirsh V, Bhar P, Zhang H, Iglesias JL, Renschler MF Weekly nab-paclitaxel in combination with carboplatin versus solvent-based paclitaxel plus carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer: final results of a phase III trial. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2012 Jun 10;30(17):2055-62

Additional Information

For additional information regarding Abraxane or non-small cell lung cancer, please visit the Abraxane web page.