Abraxane(paclitaxel protein-bound particles)

Abraxane (paclitaxel protein-bound particles) received orphan-drug designation and was approved on September 6, 2013. It is indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine. Other indications include metastatic breast cancer after failure of combination chemotherapy or relapse within 6 months of adjuvant chemotherapy, and locally advanced or metastatic non-small cell lung cancer (NSCLC) as first-line treatment in combination with carboplatin for patients not candidates for curative surgery or radiation therapy.

In a study for metastatic adenocarcinoma of the pancreas, Abraxane/gemcitabine demonstrated a median overall survival of 8.5 months, compared to 6.7 months for gemcitabine alone, representing an increase of 1.8 months. The overall survival hazard ratio was 0.72 (95% CI: 0.62, 0.83; p-value < 0.0001). Median progression-free survival was 5.5 months for Abraxane/gemcitabine versus 3.7 months for gemcitabine alone, with a hazard ratio of 0.69 (95% CI: 0.58, 0.82; p-value < 0.0001). The complete response rate in the gemcitabine arm was 0%.

Safety findings include severe pyrexia in 3% of patients in the ABI-007 + Gemcitabine arm, compared to 1% in the Gemcitabine arm. Severe rash was observed in 2% of patients, and severe arthralgia and insomnia each in 1% of patients. Neutropenia related to the study drug leading to interruption occurred in 13% of patients in Phase 1.