DifGen Pharmaceuticals has announced 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.
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 PK profile comparable to that of the reference product.
The clearance reflects DifGen’s formulation and clinical development capabilities and its focus on identifying efficient development pathways for technically complex programmes.
