FDA Approved Abraxane for First-Line Therapy of Non–Small-Cell Lung Cancer

October 2012, Vol 3, No 7 - FDA Approvals, News & Updates


“Non–small cell is the most common type of lung cancer, the leading cause of cancer death in the United States,” said Mark A. Socinski, MD, Director, Lung Cancer Section, Division of Hematology/Oncology, University of Pittsburgh, and lead investigator of phase 2 and phase 3 clinical trials of paclitaxel protein-bound in lung cancer. “The FDA approval of Abraxane is exciting for healthcare professionals, because it offers an important new treatment option for all types of non–small-cell lung cancer patients, in an area that has seen few treatment advancements in recent years,” Dr Socinski said.

The approval of this new indication for paclitaxel protein-bound particles is based on the results of a phase 3, multicenter, open-label study of patients with advanced NSCLC who were randomized to paclitaxel protein-bound 100 mg/m2 weekly plus carboplatin (AUC = 6) every 3 weeks (N = 521) or to generic paclitaxel 200 mg/m2 every 3 weeks plus carboplatin (AUC = 6) (N = 531). Overall response rate—the primary end point—was significantly higher with protein-bound paclitaxel particles compared with the generic paclitaxel (33% vs 25%, respectively).

In addition, paclitaxel protein-bound particles demonstrated a higher overall response rate for squamous-cell carcinoma compared with paclitaxel (41% vs 24%, respectively) and for large-cell carcinoma (33% vs 15%, respectively).

Paclitaxel protein-bound particles achieved a similar overall response rate to generic paclitaxel in patients with carcinoma or adenocarcinoma (26% vs 27%, respectively).

The most common (ie, ≥20%) adverse reactions reported with paclitaxel protein-bound particles in combination with carboplatin for NSCLC are anemia, neutropenia, thrombocytopenia, alopecia, peripheral neuropathy, nausea, and fatigue.

Paclitaxel protein-bound is already approved for the treatment of patients with metastatic breast cancer after failure of combination chemotherapy.

The manufacturer has filed regulatory submissions for paclitaxel protein-bound particles for the treatment of NSCLC in Japan, Australia, and New Zealand, and final decisions are expected in 2013.