The FDA has approved Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) for a new indication, first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC), the manufacturer, Celgene Corp., announced today. The medication is to be used in combination with carboplatin in patients who are not candidates for curative surgery or radiation therapy.
This is the second approved indication for Abraxane; the drug was first approved in 2005 for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy.
According to a Celgene press release, in a Phase III, multicenter, randomized open-label study in patients with advanced NSCLC, one group received Abraxane (100 mg/m2) weekly plus carboplatin (area under the curve [AUC] =6) every three weeks (n=521); the other group received paclitaxel (200 mg/m2) every three weeks plus carboplatin (AUC =6) (n=531). The study met its primary end point, with patients in the Abraxane group showing a higher overall response rate than those in the paclitaxel group (33% vs 25%).
Abraxane demonstrated a higher overall response rate compared with paclitaxel for squamous cell carcinoma (41% vs, 24%) and large cell carcinoma (33% vs, 15%). For carcinoma/adenocarcinoma, the overall response rate in Abraxane and paclitaxel was similar (26% vs, 27%).
The most common adverse reactions (=20%) of Abraxane in combination with carboplatin for NSCLC are anemia, neutropenia, thrombocytopenia, alopecia, peripheral neuropathy, nausea and fatigue. Abraxane carries a boxed warning regarding neutropenia.
Non-small cell is the most common type of lung cancer, the leading cause of cancer death in the United States,” Mark A. Socinski, MD, director, Lung Cancer Section, Division of Hematology/Oncology, University of Pittsburgh, and lead investigator of Abraxane lung cancer Phase II and III trials, said in a statement. “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.