Sorrento Therapeutics announced that the first patient has been dosed in the pivotal clinical trial designed to support approval of Cynviloq for the treatment of metastatic breast cancer and non-small cell lung cancer. The registration trial referred to as Trial designed to evaluate Bioequivalence between Cynviloq and Abraxane, or TRIBECA. A projected 100 patients with metastatic or locally recurrent breast cancer will be administered 260 mg/m2 of Cynviloq or 260 mg/m2 of Abraxane using a 30 minute infusion in a crossover design to compare the bioequivalence of both drugs. Based on the End-of-Phase II meeting with the FDA in July 2013, this trial was designed to gain marketing approval for Cynviloq under the 505(b)(2) regulatory pathway in the U.S. Sorrento expects to file a New Drug Application with the FDA in the first half of 2015.
- Health Care Industry
- metastatic breast cancer