Generic pharmaceuticals manufacturer DifGen Pharmaceuticals LLC announced on Monday that the US Food and Drug Administration (FDA) has accepted the company's Investigational New Drug (IND) application and issued a 'study may proceed' letter for DFGN-101, an intramuscular injection under development for the treatment of advanced or metastatic breast cancer in women.

The company says that DFGN-101 is designed to be administered as a single intramuscular injection, compared with the two separate injections required for the currently marketed reference product. If approved, the product would reduce the number of injections a patient receives at each treatment visit.

Under the agreed development pathway, DifGen will proceed with preclinical toxicology studies in rat and rabbit and a Phase 1 pharmacokinetic study. A clinical endpoint/efficacy study is not required. The FDA's position was supported by the company's Chemistry, Manufacturing and Controls (CMC) data package and by results from a pilot pharmacokinetic study showing a pharmacokinetic profile comparable to that of the reference product.