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fda approves janssen's cancer therapy for people with myeloma
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carvykti requires a significant amount of preparation and training for doctors and nurses to properly treat patients. getty
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a new cell-based treatment for blood cancer developed by johnson & johnson and its china-based partner legend biotech corp is now fda-approved for use in the united states.
carvykti, a chimeric antigen receptor t-cell therapy, is designed for use in people with multiple myeloma, a form of blood cancer. the treatment will be used on patients who have already undergone four or more other lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and a monoclonal antibody.
“we are committed to harnessing our science, deep disease understanding and capabilities to bring forward cell therapies like carvykti as we continue to focus on our ultimate goal of delivering a cure for multiple myeloma,” peter lebowitz, global therapeutic area head of oncology at janssen research & development said. “we extend our sincere gratitude to the patients, their families and the teams of researchers and study centres who have participated in the clinical study of carvykti and enabled today’s approval.”
one of j&j’s studies, dubbed cartitde-1, which factored significantly into the approval process, found 98 per cent of patients responded to the treatment. additionally, 78 per cent experienced such a positive response that doctors were not able to see any signs of multiple myeloma at a follow up appointment, which was roughly two years after the treatment.
carvykti requires a significant amount of preparation and training for doctors and nurses to properly treat patients, so much so that certification courses will be offered by janssen and legend biotech, the companies that helped develop the treatment.
a limited network of certified treatment centres will start providing care in the united states later this year, with more planned to be established in the near future.
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a vision for ‘eliminating cancer’
“this approval of janssen’s first cell therapy is a testament to our continuing commitment in oncology to deliver new therapeutic options and drive toward our vision of the elimination of cancer,” mathai mammen, executive vice president of pharmaceuticals at janssen r&d and johnson & johnson said. “today’s approval underscores our determination to develop therapies that can help patients living with what remains an intractable blood cancer today and at the same time offer hope for the future.”
the response to the study, and the 18-month follow up to monitor patients longer term, showed the treatment has durability over time, sundar jagnnath, director of the centre of excellence for multiple myeloma and principal study investigator said, adding that the approval of the treatment provides an opportunity for therapy that can let patients live myeloma-free for a period of time.
researchers are still looking into the long-term efficacy and safety of the treatment to determine how effective it will be in the future, though a 22-month follow up found that 83 per cent of patients were still responding positively.
multiple myeloma is an incurable blood cancer caused by a buildup of abnormal plasma cells, or white blood cells that make antibodies, in bone marrow, according to the canadian cancer society. the disease makes it difficult for the bone marrow to develop, which can cause anemia and fatigue due to a reduced amount of red blood cells. multiple myeloma can also cause bone tumours. despite some treatments being available, the five-year survival rate for multiple myeloma is 54 per cent.
most myeloma patients (male and female) are diagnosed between 70 to 80 years of age, reports myeloma canada — people under the age of 45 make up just four per cent of those diagnoses.
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it is estimated that in 2021, 3,800 canadians were diagnosed with multiple myeloma — 2,300 men and 1,500 women, the canadian cancer society reports. additionally, 1,600 of the 3,800 diagnosed are estimated to have died.
chris arnold is a toronto-based writer.
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