The FDA’s decision was based, in part, on review of both phase I and phase II clinical trials of AP23573 conducted by Ariad in refractory sarcoma patients, and the recognition that soft tissue and bone sarcomas are serious and life-threatening conditions for which treatment options are limited or non-existent.
Based on the announcement, Ariad will pursue treatment of soft tissue and bone sarcomas as the initial registration path for AP23573.
The benefits of the FDA’s fast-track program include closer and more frequent interactions with the agency during clinical-trial planning and new drug application (NDA) filing and generally a higher likelihood of being granted accelerated approval on the basis of a surrogate measure of clinical benefit in cancer patients, such as progression-free survival.
“We believe that the FDA’s fast-track designation for AP23573 is the company’s most important milestone to date,” said Dr Harvey Berger, chairman and CEO of Ariad. “Since there are no effective therapies currently available for advanced soft-tissue sarcomas or metastatic refractory sarcomas in general, the FDA decision represents a potential breakthrough for patients with an otherwise untreatable cancer.”