DifGen Pharmaceuticals said the FDA has accepted its investigational new drug application and issued a “study may proceed” letter for DFGN-101, a single intramuscular injection being developed for advanced or metastatic breast cancer in women.
The company said DFGN-101 is designed to be given as one intramuscular injection, compared with two separate injections required for the currently marketed reference product. If approved, the approach could reduce the number of injections patients receive during each treatment visit.
Under the agreed development pathway, DifGen will now move ahead with preclinical toxicology studies in rats and rabbits, followed by a Phase 1 pharmacokinetic study. The company said a separate clinical endpoint or efficacy study is not required for the program.
DifGen said the FDA’s decision was supported by its chemistry, manufacturing and controls package and by results from a pilot pharmacokinetic study, which showed a profile comparable to that of the reference product. The company described the clearance as validation of its formulation and clinical development capabilities, as well as its focus on finding efficient development routes for technically complex drug programs.
The announcement marks an early step in the development of DFGN-101, which is intended to simplify treatment delivery for women with advanced breast cancer. DifGen said the streamlined pathway may help accelerate progress toward later-stage development while reducing the burden of administration compared with the current product format.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!