Company Directory

Single-Patient EA Policies/Criteria

Taiho Oncology, Inc. (“Taiho”) is committed to helping patients with cancer obtain access to new treatments. While we believe this is best accomplished through participation in clinical trials, we recognize that this is not always possible for every cancer patient. In such situations, Taiho may be able to provide pre‑approval access to an investigational drug through our Expanded Access Program. Expanded Access, also known as Compassionate Use, is the use of an investigational medical product intended to diagnose, monitor or treat a patient's disease or condition, prior to FDA approval and outside of use in a clinical trial. Taiho accepts requests for pre‑approval access to investigational cancer medicines from physicians only.

To be eligible for access to an investigational medicine, a physician must apply and certify that the patient for whom the application is being submitted meets the following criteria*:

• The patient is suffering from a serious or life‑threatening malignancy and has received available standard treatments without success
• The patient is not eligible to participate in any ongoing clinical study of the Taiho investigational agent
• The medicine requested is part of an active ongoing clinical development program at Taiho Oncology (US) as described on our website: www.taihooncology.com/us under the tab for ‘Our Science’
• Provision of the investigational agent will not interfere with the ongoing Taiho development program, and the potential benefits to the patient outweigh the potential risks

A physician may click here to obtain an application form, submit the completed form, or submit questions about Taiho's Expanded Access Program, via email to ExpandedAccess@taihooncology.com. (For futibatinib specific requests, click here to obtain the application form).

* Note that meeting these criteria does not guarantee access to any investigational product.

Disease/Category-Specific EA Policies/Criteria

EXPANDED ACCESS TO INVESTIGATIONAL DRUGS

https://www.takedaoncology.com/medicines/expanded-access-to-investigational-drugs/

Single-Patient EA Policies/Criteria

TG Therapeutics is committed to bringing our investigational therapies for B-cell malignancies and autoimmune diseases to patients as fast as possible. We believe the best way for patients to access our investigational therapies is through participation in clinical trials, with the goal of obtaining regulatory approval of our products and allowing access to the broadest group of patients possible.

At this time, TG Therapeutics does not have a program to provide its investigational therapies to patients on an expanded access basis pursuant to section 561(b) of the U.S. Federal Food, Drug, and Cosmetic Act (FDCA). Because we do not currently have an expanded access program, we have not yet established procedures for making such requests or criteria for evaluating them. TG Therapeutics will update this policy if the company decides to make its investigational therapies available on an expanded access basis.

Patients may be able to access TG Therapeutics investigational therapies by participating in ongoing clinical trials. Whether or not a patient is eligible to enroll in any of our trials depends on a number of factors, including the specific requirements of each trial and the status of that trial. For more information about our trials, please visit Our Trials Overview or https://clinicaltrials.gov/ct2/results?cond=&term=%22tg+therapeutics%22&cntry=&state=&city=&dist.

TG is committed to responding to questions about its expanded access policy within five (5) business days of receipt. As noted above, at this time, we are not providing our investigational therapies on an expanded access basis.

Available Therapies via Single-Patient EA

G207 for pediatric high grade gliomas

Single-Patient EA Policies/Criteria

Trevi Therapeutics, Inc. is currently unable to offer Expanded Access.

Available Therapies via Single-Patient EA

Currently, Trevi Therapeutics, Inc. does not have any investigational products available for Expanded Access.

Disease/Category-Specific EA Policies/Criteria

https://www.trevitherapeutics.com/patients-2/

Single-Patient EA Policies/Criteria

Trinomab is dedicated to discovering and developing novel native human monoclonal antibody (mAb) drug. Trinomab’s lead product, TNM002 injection, is the first recombinant native human mAb against tetanus toxin and is indicated for prophylaxis against tetanus. Currently, TNM002 has completed phase I clinical trials. A phase II clinical trial is ongoing. The results of clinical trials show that TNM002 has excellent safety and efficacy profiles, with low risk of immunogenicity. At Trinomab, we focus on conducting clinical trials aimed at gaining regulatory approval, making TNM002 available to patients as early as possible. Trinomab understands the interest of patients in accessing TNM002 outside of clinical trials and prior to regulatory approval for potentially life threatening diseases, however we do not currently offer any Expanded Access Programs for TNM002. Trinomab recognizes the need for Expanded Access Programs and will continue to evaluate of our policy based on data from ongoing and future clinical trials and the clinical development plan in the U.S.

Single-Patient EA Policies/Criteria

Trinomab is dedicated to discovering and developing novel native human monoclonal antibody (mAb) drug. Trinomab’s lead product, TNM002 injection, is the first recombinant native human mAb against tetanus toxin and is indicated for prophylaxis against tetanus. Currently, TNM002 has completed phase I clinical trials. A phase II clinical trial is ongoing. The results of clinical trials show that TNM002 has excellent safety and efficacy profiles, with low risk of immunogenicity. At Trinomab, we focus on conducting clinical trials aimed at gaining regulatory approval, making TNM002 available to patients as early as possible. Trinomab understands the interest of patients in accessing TNM002 outside of clinical trials and prior to regulatory approval for potentially life threatening diseases, however we do not currently offer any Expanded Access Programs for TNM002. Trinomab recognizes the need for Expanded Access Programs and will continue to evaluate of our policy based on data from ongoing and future clinical trials and the clinical development plan in the U.S.

Single-Patient EA Policies/Criteria

Triumvira Immunologics, Inc. is dedicated to developing new therapies that have a positive impact on patient health, and to serving patients, patient families and patient communities through education, empathy, and awareness. Consistent with Triumvira, Inc.’s mission to bring innovative medicines to patients with serious or life-threatening illnesses or conditions, we are focused on enrolling and conducting the clinical trials necessary to gain regulatory approvals to make our medicines available broadly to patients as quickly as possible. We are privileged to collaborate with clinical investigators and with patients who participate in our studies to develop new, safe and effective therapies. We believe this approach will serve patients who could be helped by the therapies we are developing.

At the same time, we understand that there are seriously ill patients who will not be eligible for our clinical trials and may not have options for alternative therapies, including investigational therapies in trials being conducted by other sponsors. In these circumstances, Triumvira, Inc. will consider providing a requesting physician with pre-approval access to a specific investigational drug, for the treatment of an individual patient outside of a clinical trial, when certain conditions are met. These conditions include the following:

• The patient has a serious or life-threatening illness or condition and is either no longer responsive to or no longer able to tolerate any available treatment option;
• The investigational drug is in active clinical development with sufficient data available to determine an appropriate dose and schedule for the patient’s specific condition;
• A benefit-risk analysis, based on both the available clinical data as well as the requesting physician’s assessment of the individual patient’s condition and history, supports making the investigational drug available;
• Making the investigational drug available will not negatively impact or delay the conduct of clinical trials or regulatory review or approval of the investigational drug for broader patient access; and
• Adequate supply of the investigational drug is available.

We continually evaluate the benefit-risk profile of each of our investigational drugs based on evolving clinical data. Each compound under development is different and the fact that one investigational drug is made available for the treatment of a particular patient does not mean it will be made available in response to other requests on behalf of other patients whose circumstances and medical histories may be different, or that a different investigational drug will be made available under our policy. Requests will be considered on a case-by-case basis.

Triumvira is committed to evaluating all requests in a fair and equitable manner. All requests must be submitted by the patient’s treating physician; Triumvira may require more detailed information in order to fully evaluate a request. The requesting physician must agree to obtain appropriate regulatory and ethics committee approvals and comply with regulatory obligations, including obtaining patient consent, patient monitoring and safety reporting. Each request will be given careful consideration by Triumvira whose decisions are final. Physicians seeking pre-approval access for patients with no alternative treatment options should submit their requests to Partners@Triumvira.com. We regularly monitor this mailbox and will use our best efforts to acknowledge each submitted request within 3 business days after receipt.

Available Therapies via Single-Patient EA

TAC01-CD19, autologous TAC (T cell antigen coupler) T cells, single infusion, multiple dosage levels.

Indication: B-Cell Lymphoma

Single-Patient EA Policies/Criteria

TVAX Biomedical, Inc. (TVAX) is committed to developing immunotherapies for patients with serious cancers. Our goal is to provide access to our investigational therapies primarily through clinical trials. At this time, TVAX does not have any investigational immunotherapy product available for expanded access.

“Expanded Access” refers to the use of an investigational therapy outside of a clinical trial for potential treatment of a serious condition in a patient. The US Food and Drug Administration has set forth guidelines when considering expanded access.

TVAX is not currently making its investigational immunotherapy product candidates available on an expanded access basis anywhere in the world. Requests for expanded access to TVAX Biomedical’s investigational immunotherapy product candidates must come from the patient’s treating physician because only physicians can enroll patients in a clinical trial or the expanded access program.

Certain therapies, like TVAX Immunotherapy, are made through complex manufacturing processes. TVAX seeks to retain the ability to make and supply product in a fair and equitable manner and in a volume that assures adequate manufacturing capacity for clinical trials and development programs. TVAX believes that participation in one of its’ clinical trials is the most appropriate way to access these investigational therapies.

At this time, TVAX is not currently making its unapproved therapies available on an expanded access or right to try basis. In the event TVAX decides to consider expanded access or right to try use, TVAX will evaluate and respond to each request that it receives on a case-by-case basis.

If you have questions, please speak with your physician or contact TVAX at info@tvaxbiomedical.com.

Consistent with the 21st Century Cures Act, TVAX may revise this policy at any time.