Early Licensure Of A Breakthrough Cancer Drug Gives Hope To Patients

No clinical supply request could be a higher priority than that of a physician urgently seeking an investigational cancer drug for a patient who has exhausted all treatment options.

Fortunately, governments worldwide have made provisions for patients who don’t qualify for clinical trials and have no remaining treatment options to gain access to drugs prior to licensure. In the European Union (EU), for example, named patient programs (NPPs) provide pre-approval access to drugs in response to requests of doctors on behalf of specific or “named” patients. The equivalent to NPPs in the United States are known as expanded access or compassionate use programs.