We are committed to helping patients who have not had success with existing, available therapies and may benefit from our investigational therapies currently in development. Loxo Oncology’s Policy for Access to Investigational Agents describes the principles and procedures that the company will follow when considering a request. Please see below for further details.
Cancer is a life-threatening illness that is often poorly treated by available therapies. Loxo Oncology was founded to address this unmet medical need. Our product pipeline consists of investigational therapies for cancer that are currently being tested in clinical trials and have not yet been approved by the US Food and Drug Administration (FDA) or other regulatory bodies for commercial sale. We have conducted and are conducting research on our investigational product pipeline so that we can better understand how these investigational therapies work, which cancers in humans are most likely to benefit from these investigational therapies, and how to understand fully the safety and efficacy of the investigational therapies.
Patients with cancer often exhaust standard treatment options and seek out investigational therapies being tested in clinical trials. People who take part in clinical trials help society by contributing to medical research, the development of new therapies, and the advancement of patient care. Other times, patients may not be able to participate in a clinical trial. When patients are not able to participate in a clinical trial, their physicians may request that a drug company like Loxo Oncology makes its investigational therapy available outside of a clinical trial.
Loxo Oncology is committed to helping patients who have failed available therapies and may benefit from treatment access to the investigational therapies that we are developing in a manner that is both scientifically and ethically responsible. This Loxo Oncology Policy for Access to Investigational Agents describes the principles, criteria and government regulations that we will follow when considering a request for access to an investigational agent outside of a clinical trial.
1. The investigational therapy must be in active clinical development. Loxo Oncology must be actively studying the investigational therapy in human subjects. In this way, Loxo Oncology is able to comply with local regulations regarding manufacturing, preclinical safety and reporting obligations. Restricting access to investigational therapies with active clinical programs also ensures that there are Loxo Oncology personnel who are trained and responsible for the safe release of the investigational therapy. A possible exception to this criterion could exist in a case where an investigational therapy is in the later stages of preclinical testing, on its way to clinical testing, though an acute medical need requires earlier access. In such a case, Loxo Oncology, at its sole discretion, could explore the safety and feasibility of providing access, so long as relevant regulatory authorities are in agreement.
2. Patients must be first considered for ongoing clinical trials of the investigational therapy. Treating physicians interested in treating their patient with Loxo Oncology investigational therapies in active clinical development must first try to enroll their patients in a clinical trial studying the investigational therapy. Clinical trials incorporate regular safety monitoring, and create a venue for investigator training on the potential risks of the investigational therapy. In addition, Loxo Oncology has a scientific and ethical obligation to complete clinical trials that could support health authority approval of the medicine. Clinical trials have the ability to establish clinical benefit for the investigational therapy, and thus transform an investigational therapy into an approved drug capable of offering benefit to a wider population.
3. The patient must have a serious disease or condition.
4. There must be a positive benefit-risk ratio for the patient. The potential benefits to the patient seeking access to the investigational therapy must always outweigh the collective potential risks to the patient of offering the investigational therapy. In establishing the benefit-risk ratio, Loxo Oncology will consider the outcome of the disease itself.
5. The physician who requests access must be qualified, agree to directly supervise treatment, be willing to obtain relevant health authority approval/clearance, otherwise comply with relevant local and/or country regulations, and agree to follow Loxo Oncology policies applicable to expanded use in general and any conditions or restrictions set by Loxo Oncology for the particular drug and patient. The physician may be asked to comply with special monitoring procedures and to provide ongoing clinical information, as requested by Loxo Oncology. Such requests would be made in the interest of patient safety and ensuring that a positive benefit-risk ratio persists for the patient.
6. The physician requesting access must provide:
7. There must be sufficient clinical data to identify an appropriate dose (amount and frequency of the investigational therapy given) and appropriate formulation.
8. After meeting the needs of clinical trials and other existing patients on therapy, Loxo Oncology must have a sufficient supply of the investigational therapy to reasonably accommodate the likely duration of treatment.
1. Treating physicians interested in treating a patient with a Loxo Oncology investigational drug that is in active clinical development must submit the Loxo Oncology Expanded Access Program request form to email@example.com. Treating physicians should take care not to include identifying personal health information (PHI).
2. Loxo Oncology will acknowledge a satisfactorily completed and submitted request via email within 5 business days.
3. Making a request does not guarantee the granting of access to an investigational drug. Loxo Oncology will review the request in the context of its Policy for Evaluating Access to Investigational Agents Outside of Loxo Oncology Clinical Trials. Loxo Oncology will attempt to make a decision to grant or deny the request, or ask for more information, within 10 business days.
Questions about Loxo Oncology’s policy and procedures for expanded access, or about expanded access to Loxo Oncology investigational drugs, should be sent by email to: firstname.lastname@example.org.