The purpose of this policy is to describe the requirements for expanded access to ArQule investigational products, derazantinib (ARQ 087) and miransertib (ARQ 092), to patients outside of our current clinical trials who have serious or life-threatening diseases and lack other therapeutic options.
We at ArQule are devoted to providing transformative therapies to patients in need. Clinical trials allow us to evaluate investigational new treatments in order to generate the safety and efficacy data needed to obtain approval for our products from FDA, EMA and other regulatory bodies. These clinical studies are required by regulatory authorities to fully answer important scientific questions about the potential risks and benefits of our investigational products. Information about ArQule’s currently enrolling clinical trials can be found at the www.clinicaltrials.gov website.
ArQule also supports expanded access (“compassionate use”) to investigational products when there is substantial scientific evidence to support both the safety and the efficacy of a product, when it is logistically feasible, and when permitted by applicable law. We know that many of the patients seeking access to our investigational medicines are facing a serious or life-threatening illness and have no treatment options or a clinical trial available to them, so we take requests for compassionate use of our products very seriously.
Physicians and patients can learn more about the FDA’s requirements for compassionate use at www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse.
Any use of an ArQule investigational product outside a clinical study must be in accordance with local laws and regulations governing such programs. A treating physician, who is able to comply with this policy, may request information about how to apply for access to ArQule’s investigational products by contacting our Medical Affairs group at ClinicalTrials@arqule.com.
The patient for whom treatment with an investigational medicine is sought:
Also, the requested investigational product must meet the following criteria:
In addition, the physician attending to the patient must be properly licensed and fully qualified to administer the product in his/her country.
The physician must also agree in writing to comply with:
Treating physicians should submit expanded access requests on behalf of patients directly to ClinicalTrials@arqule.com. The submission must contain a brief patient history, sufficient information on the patient’s current medical status, and contact information of the treating physician. The submission must not contain any patient identifying information, such as names or ID numbers.
ArQule anticipates responding to the treating physician within five business days. If the request is supported by ArQule, the treating physician must apply for and receive approval from the applicable country regulatory authority to allow for importation of the investigational product.
ArQule is committed to assessing every access request with the highest degree of ethical responsibility, but cannot guarantee that all requests for access will be granted, even when eligibility criteria are met.
In accordance with the 21st Century Cures Act, ArQule reserves the right to revise this policy at any time.
Effective August 31, 2017