At TESARO, we are devoted to providing transformative therapies to people facing cancer. We seek to provide those therapies to the broadest group of patients possible by engaging in clinical research with the goal of obtaining regulatory approval for our products. Clinical studies allow us to evaluate investigational treatments in order to generate the safety and efficacy data needed to obtain such approval. Information about how to enroll in current TESARO clinical studies can be found at clinicaltrials.gov.
We also support expanded access to investigational products when we have substantial scientific evidence to support both the safety and the efficacy of a product for an indication, when it is logistically feasible, and when permitted by applicable law.
For a specific population, TESARO is committed to promptly evaluating requests for expanded access for individual use, also known as compassionate use, to TESARO investigational products. You can learn more about the FDA’s regulatory framework for expanded access, including expanded access for individual use, on the FDA’s website.
The above criteria are those that TESARO will consider in determining whether to offer expanded access for individual use; however, TESARO cannot make a guarantee that the investigational therapy will be available to a particular patient. If all these conditions are met, TESARO will consider expanded access for individual use requests from treating physicians subject to local/national laws and regulations. All requests will be evaluated in a fair, unbiased manner.
Requests for access to investigational therapies must be made by a qualified and licensed physician by contacting TESARO medical information. All individual requests will be acknowledged within three business days of receipt.
You can reach TESARO Medical Information via our Contact form or by calling 1-844-4-TESARO [844-483-7276].