At TESARO, we are devoted to providing transformative therapies to people bravely 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 trials allow us to evaluate investigational new treatments in order to generate the safety and efficacy data needed to obtain such approval. Information about TESARO’s currently enrolling clinical trials can be found at clinicatrials.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 information about the treatment protocol niraparib expanded access program (“niraparib EAP”), please click here and see the listing at https://clinicaltrials.gov/ct2/show/NCT03025867.
TESARO is committed to promptly evaluating requests for expanded access for individual use, also known as compassionate use, to TESARO’s investigational products. You can learn more about the FDA’s regulatory framework for expanded access, including expanded access for individual use, at www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse
Criteria used for considering requests for individual expanded access are:
- The patient has a serious or immediately life-threatening cancer.
- There is no comparable or satisfactory alternative therapy for the disease or condition.
- The patient does not qualify for participation in, or have access to, any ongoing TESARO clinical trials.
- There is substantial scientific evidence to expect that the patient may derive a clinically meaningful benefit and that the investigational product will have an acceptable safety profile in the relevant indication, typically after positive Phase II or Phase III data is available, to support a robust risk-benefit analysis.
- There is substantial scientific evidence to support an appropriate dose (amount and frequency) for the investigational product.
- The investigational product is under active development by TESARO, and access on an expanded access for individual use basis will not delay, interfere with, or compromise clinical trials or the regulatory pathway for the product.
- There is adequate supply of the investigational product.
- The compound can be administered – and it is logistically feasible to make it available – outside of the clinical trial setting.
- Whether the relevant patient’s underlying medical conditions pose safety risks that have not been sufficiently studied.
- The request has been made by a qualified and licensed physician in the United States with expertise and facilities appropriate for the administration of the therapy, monitoring, managing and reporting side effects, as well as patient experience.
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.
TESARO Medical Information can be reached at 1-844-4-TESARO [844-483-7276].