The companies want the label to include additional information that Erbitux improves overall survival in the third-line treatment of patients with metastatic colorectal cancer The FDA has granted the application a priority review, which means that the likely action date for the sBLA is early October. If the sBLA is approved, Erbitux would be the only biologic therapy to demonstrate overall survival as a single agent in patients with metastatic colorectal cancer, the companies said.
The sBLA, which is based on results from a large, randomized, multicenter, phase III trial, seeks to update the monotherapy indication to include patients with EGFR-expressing mCRC whose disease has progressed following, or who were not candidates to receive, irinotecan- or oxaliplatin-based chemotherapy. The sBLA also seeks to include data on overall survival relative to best supportive care – considered to be all approved palliative therapies designed to alleviate pain and treat other effects caused by advanced colorectal cancer in this patient population.
Currently, in mCRC, Erbitux is indicated as a monotherapy for EGFR-expressing mCRC patients who are intolerant to irinotecan-based therapy. Erbitux is also approved in combination for the treatment of EGFR-expressing, mCRC in combination with irinotecan for patients who are refractory to irinotecan-based chemotherapy; this combination indication would remain unchanged. These indications were approved based on objective response rates.