Source: Environmental Protection Authority
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.”
Read more about this approval decision
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