Clovis Compassionate Use Policy
At Clovis Oncology, we are committed to developing safe and effective therapies for cancer and providing those therapies as quickly as possible to the patients most likely to benefit based on our understanding of how the therapies work. As part of that commitment, we support providing access to rucaparib as an investigational product for patients that have a type of cancer for which rucaparib is not currently approved, provided there is substantial scientific evidence to support both the safety and potential efficacy of rucaparib in that cancer type and when it is logistically feasible. It is important to note that in the U.S. rucaparib is currently only approved for the treatment and the maintenance treatment of ovarian cancer and for the treatment of prostate cancer, and that all other indications are considered investigational. Thus, the potential risk/benefit profile for rucaparib outside the approved indications has not yet been established. Physicians and patients should consider all possible risks and potential benefits when seeking access to rucaparib for investigational use.
Clovis Oncology uses the following criteria for considering requests to provide access to rucaparib for individual patients for a non-approved indication:
- The patient has been diagnosed with a solid tumor.
- The patient has received standard therapies for treatment of their solid tumor.
- The patient does not qualify for participation in or does not have access to ongoing rucaparib clinical trials; information regarding Clovis-sponsored clinical studies can be found at clinicaltrials.gov.
- The patient has a life expectancy of at least 30 days.
- The patient's underlying medical conditions does not pose a safety risk, based on the rucaparib safety profile described in the USPI.
- There is evidence that the patient’s tumor has a deleterious mutation in one of the following genes: BARD1, BRCA1, BRCA2, BRIP1, FANCA, PALB2, RAD51, RAD51B, RAD51C, RAD51D.
- The request has been made by a qualified and licensed physician who will comply with all institutional, ethics and health authority requirements in the region where the patient will be treated, and who will routinely exchange patient safety data with Clovis under an exchange agreement.
- There is adequate supply of rucaparib available and adequate internal resource at Clovis Oncology to support fulfillment of the request. In addition, Clovis reserves the right to assess each request for potential benefit/risk.
A U.S. treating physician may request access to rucaparib for a patient by contacting Clovis Medical Information at:
U.S. Contact Information
1-844-258-7662 (U.S. toll-free)
1-415-409-7220 (U.S. toll)
All requests must include the following information:
- Requesting physician's name, contact information, address (including country), and professional designation (i.e., MD) or qualifications.
- Relevant medical information for the patient, including type of cancer, treatments received, relevant medical history and current status, and evidence of potentially relevant biomarker.
- Physician’s commitment to follow institutional and regulatory requirements where the patient is treated.
- Date of request.
Clovis will respond to a physician’s request for access to rucaparib within 30 days.
For non-U.S. Healthcare Providers
For any requests for rucaparib outside of the U.S., please contact Clovis Medical Information at:
UK Contact Information
+44 (0)800 0093361 (UK toll-free)
+44 (0)3301 004723 (UK toll)