We understand that sometimes people may seek access to investigational medicines before they are reviewed and approved by a regulatory authority, such as the U.S. Food and Drug Administration (FDA). This can be done in two ways – through clinical trials and expanded access.

SALA-002-EW16 is currently recruiting Ewing sarcoma, myxoid liposarcoma, desmoplastic small round cell, and several other types of sarcomas that share a genetic abnormality with Ewing sarcoma.  For more information, you can visit our study website at https://sala-002-ew16.researchstudytrial.com/.   Para español, visite  https://sala-002-ew16-es.researchstudytrial.com/. 

Our goal, whenever possible, is to encourage patients to participate in clinical trials. Clinical trials are research studies designed to determine if an investigational medicine is safe and effective for patients. Data generated by these studies provide regulatory authorities with essential information needed to evaluate a medicine. Only after reviewing this information will regulators approve a new medicine, allowing it to be widely available.

In rare cases, however, when people don’t qualify for clinical trials, have exhausted all available medical option and the investigational medicine has demonstrated some preliminary efficacy and safety; companies may consider providing an investigational medicine outside of a clinical trial. This is called expanded access.