Processa Pharmaceuticals, Inc. plans to expand the development of Next Generation Capecitabine (“NGC-Cap”) into the treatment of advanced or metastatic breast cancer beginning with its next Phase 2 trial. Following the Processa meeting with the FDA, Processa has decided the next NGC-Cap trial would be a Phase 2 trial in breast cancer. This decision was supported through discussions with the FDA where Processa agreed with the FDA that pursuing breast cancer will lead to a more efficient development program while providing a greater likelihood of FDA approval. The FDA stated that the previously generated data in past and existing studies could be used to directly support the Phase 2 trial in breast cancer.
Breast cancer is the most diagnosed cancer, representing approximately 15% of all new cancer patients in 2023. It has a prevalence of more than 3.8 million patients, with nearly 300,000 new diagnoses last year. Over 150,000 women are currently living with advanced or metastatic breast cancer. The NGC-Cap potential market for breast, colorectal and other cancers is greater than 250,000 patients per year.
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