Products

Voraxaze^® US Treatment IND

Access to Voraxaze^® (glucarpidase) is available in the US under an expanded access and cost recovery programme.

Procedure to acquire glucarpidase under the intravenous (IV) open-label treatment protocol and cost recovery programme

Glucarpidase is available in the US for intravenous (IV) administration to patients who qualify under BTG's Open-Label Treatment Protocol. BTG has partnered with CTI, Clinical Trials and Consulting Services Inc., a contract research organisation, who is managing the programme.

In order to continue to make glucarpidase available prior to FDA marketing approval, there will be a cost to obtain it under the Open-Label Treatment Protocol. BTG is permitted under the FDA regulations (21 CFR 312.8) to charge for glucarpidase, to recover direct costs associated with its manufacture, shipping, handling and costs associated with monitoring the study and complying with FDA reporting requirements, but the charge does not include other commercial costs (profit).

Investigators interested in participating in the Open-Label Treatment Protocol, and/or those investigators with potentially eligible patients, should contact the Voraxaze^® 24-hour access call center at +1 877 398 9829 to obtain more information on study participation.

The Voraxaze^® call center will answer questions about the Open-Label Treatment Protocol including verifying the patient's eligibility, discussing regulatory requirements, supplying study materials, and arranging for drug shipment/invoicing.

Prospective IRB approval is required for this study. If your institution requires local IRB approval, we suggest that you submit the protocol and consent form prior to having a patient eligible for the study.  The Open-Label Treatment Protocol and Informed Consent Form have been approved by a central IRB (Quorum Review Inc, Seattle, WA). If your site is able to utilize a central IRB, CTI can arrange for central IRB review. If you do not obtain prospective IRB approval for treatment of a patient at your institution, CTI will be unable to distribute glucarpidase. If we receive your IRB approval and other required documents by 11:00 am Central Time, drug can be shipped that day for delivery the following day (weekdays). Weekend shipments may also be possible in some cases.

Procedure to acquire glucarpidase under the intrathecal (IT) emergency use IND

Glucarpidase for intrathecal (IT) administration is available in the US free of charge for emergency use to treat IT methotrexate (MTX) overdose.

Information about the Emergency Use IND procedure that needs to be used is available on the FDA website at http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm163982.htm. The treating physician is the sponsor of the IND.

Under FDA regulation 21 CFR 312.36 (emergency use of an investigational new drug), a physician may treat a patient with glucarpidase before he/she submits an IND, as long as the manufacturer of the product agrees to provide it and FDA authorises treatment and provides the physician with an IND number by telephone or other rapid means of communication (please see below for instructions on how to acquire glucarpidase for IT use and obtain an IND number).

Emergency use procedure to acquire glucarpidase for IT MTX overdose

1.Contact BTG at +1 888 327 1027 on Monday through Friday between 08:30 and 17.30 Central Time to request glucarpidase for IT MTX overdose. We will send both you and the FDA a letter of authorisation, allowing the FDA to cross-reference BTG's IND on your behalf. The letter of cross-reference shows the FDA that BTG has given consent to supply glucarpidase to you. You will also receive from us, by email:

• Glucarpidase Investigator's Brochure
• Templates for an IT glucarpidase treatment plan and informed consent form
• FDA Forms 1571 and 1572
• Publications on IT use of glucarpidase
• Stock release form that must be completed after you receive your IND number from the FDA and returned to us when you want glucarpidase to be shipped to you (see step 3).

2. Contact the FDA at CDER Division of Biological Oncology Products in the Office of Oncology Drug Products at +1 301 796 2320 (workday telephone) or +1 301 796 9849 (fax) or +1 301 443 1240 (after-hours telephone) to obtain an IND number. Because this qualifies as an emergency situation, the FDA may authorise shipment of the drug in advance of the submission of an IND. The following information must be provided when the IND is submitted:

• Cover letter stating need for emergency use of glucarpidase
• Letter of authorisation to cross reference BTG's IND
• Brief clinical history of patient
• Informed consent statement
• Curriculum vitae of investigator
• FDA Forms 1571 and 1572
• Contact telephone number and fax number of requesting physician

3. Upon receiving approval from FDA to treat the patient, return your completed stock release form to BTG with the FDA-issued IND number, which allows BTG to distribute glucarpidase for your patient. Glucarpidase will be shipped to the address that you provide within 24 hours (weekdays).  If we receive your form by 11:00 am Central Time, drug can be shipped that day for delivery the following day.