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Access to investigational therapies

Seagen compassionate use

In some cases, a patient with a serious or immediately life-threatening disease might be interested in an investigational therapy, but the patient does not qualify for an ongoing clinical trial. These patients may be able to gain access to investigational therapies from Seagen. This practice is commonly called “compassionate use” or “expanded access.”

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Criteria for compassionate use

We base all decisions about compassionate use solely on clinical evidence. These decisions are guided by criteria that are generally accepted by the pharmaceutical and biotechnology industry.

Compassionate use may be appropriate if all of the following apply:

  • Have a serious and immediately life-threatening illness
  • Have exhausted all other available effective treatments approved for their condition and is no longer responsive to or able to tolerate these treatments
  • Be ineligible to enroll in ongoing relevant clinical trials involving the investigational product
  • Have a disease that is similar in type and stage to the indication(s) for which the investigational product is currently being studied and for which there is sufficient evidence to expect that the patient may derive a clinically meaningful benefit
  • Be willing and able to provide informed consent to use the investigational product.

Additionally, compassionate use must not interfere with the development of the investigational product or slow the company’s ability to broadly deliver the therapy to patients. Seagen must also have adequate supply of the investigational therapy.

How to request compassionate use

All requests must be submitted by a physician. If you are a patient and believe that an investigational therapy may be helpful for you, please speak with the physician who is treating your cancer.

Requests should be submitted to our Medical Affairs department at medinfo@seagen.com. We evaluate all requests promptly and will respond within 48 hours.