FDA Updates: March 7, 2011

Eribulin Gains FDA Approval as Breast Cancer Treatment

The FDA approved eribulin mesylate (Halaven), a microtubule inhibitor developed synthetically from a compound found in a sea sponge, in patients with metastatic breast cancer (MBC) who have already undergone at least 2 late-stage chemotherapy regimens. The approval was based on a study of 762 women with MBC in which median overall survival for patients receiving eribulin was 13.1 months versus 10.6 months for those receiving single-agent therapy.

Denosumab Approved for Skeletal-Related Events

The FDA approved denosumab (XGEVA) for skeletal-related events in patients with bone metastases from solid tumors. The agency did not authorize denosumab for treatment of patients with multiple myeloma. Denosumab targets a protein known as RANK ligand that contributes to bone destruction in patients with cancer.

Ipilimumab Decision Date Is Postponed Until March

According to manufacturer Bristol-Myers Squibb, the FDA has pushed its decision date on ipilimumab from December 25 to March 26. The agency determined more time is needed to review the biologics license application for the use of ipilimumab in pretreated advanced melanoma.

FDA Approves Trastuzumab for HER2-Positive Gastric Cancer

Based on positive data from the ToGA (Trastuzumab for Gastric Cancer) trial, the FDA has announced its approval of trastuzumab (Herceptin) for patients with HER2-positive metastatic gastric cancer or adenocarcinoma of the gastroesophageal junction. Trastuzumab is approved for concomitant use with a chemotherapy regimen combining cisplatin plus capecitabine (Xeloda) or 5-fluorouracil. It is the first targeted therapy cleared for use in patients with stomach cancer.