Source: MIL-OSI Submissions
Source: Environmental Protection Authority
The Environmental Protection Authority (EPA) has approved the import for release of a blood cancer immunotherapy that uses genetically modified cells from patients to target their own cancer.
CARVYKTI (ciltacabtagene autoleucel) is used to treat patients with multiple myeloma, the second most common blood cancer in Aotearoa New Zealand.
Approval for the therapy has been granted to Janssen-Cilag Proprietary Limited.
The treatment involves collecting a patient’s T-cells, genetically modifying them to create chimeric antigen receptor T-cells (CAR-T cells) and then re-introducing them to the patient, where they recognise and destroy myeloma cancer cells. T-cells are one of the most important white blood cells in the immune system.
“This process means CARVYKTI cells are genetically modified organisms (GMOs), with each GMO unique to the patient being treated,” says Dr Chris Hill, General Manager of the EPA’s Hazardous Substances and New Organisms group.
The EPA granted approval for release of the GMO without controls, only the second time this has occurred. The first was a vaccine for Japanese encephalitis virus, which was approved in 2019.
The Food and Drug Administration (FDA) in the United States approved the therapy in February 2022.
“The role of the EPA is to ensure that new organisms entering the country are safe and won’t have significant adverse effects on the health of the public, on Māori interests and cultural values, any valued species, natural habitats, or the environment,” says Dr Hill.
“And that’s the conclusion that we’ve come to in assessing this therapy, following a very rigorous assessment of the best available science and evidence-based decision making.”
In its assessment of impacts for Māori, the EPA notes the applicant’s engagement with Māori health experts who have guided the research on issues likely to be of concern. The applicant has also been encouraged to continue to explore opportunities for collaboration and partnership with iwi/hapū Māori to help develop relationships, incorporate their perspectives and better inform future work.
An application for use of this therapy has been submitted by Janssen-Cilag Proprietary Limited to Medsafe for approval and eventual sale to healthcare professionals in New Zealand.
“The EPA’s varied work includes playing a key role in fostering and enabling the safe use of innovative GMO technologies in New Zealand,” says Dr Hill.
“We have highly skilled advisors with strong science backgrounds, particularly in the areas of molecular biology, and we are very much aware that our decisions affect future generations. That is why we follow robust processes and make science-based decisions to protect the people and environment in New Zealand.”
– Section 38I of the Hazardous Substances and New Organisms Act 1996 (HSNO Act), provides for the EPA to make a rapid assessment on the effect of importing and releasing a new organism if it is a medicine or is contained within a medicine.
– CARVYKTI will not be used until it has been approved for use under the Medicines Act 1981, and any requirements under the Biosecurity Act 1993 have been met.
– Medsafe, the Department of Conservation, and the Ministry for Primary Industries were consulted during consideration of this application.
– Around 400 new cases of multiple myeloma are reported in New Zealand each year, with most of them eventually left without effective therapeutic options.
– An aging population has led to a continuous increase in the incidence of multiple myeloma in New Zealand and around the world. Māori and Pasifika peoples, especially the elderly, are disproportionately affected.
