Summary :
Johnson & Johnson’s partner, Legend Biotech, has been awarded U.S. Food and Drug Administration approval for its chimeric antigen receptor T-cell (CAR-T) therapy, Carvykti, for the treatment of multiple myeloma. CAR-T therapy represents a growing field of medicine used to treat patients with few or no other options.
Legend Biotech and Janssen, an arm of J&J, have been working on Carvykti since December 2017 for the treatment of multiple myeloma, an uncommon blood cancer. Multiple myeloma is a disease of interest in creating new therapies because a majority of patients afflicted relapse after initial treatment and face poor prognoses after treatment with three major drug classes: immunomodulatory agents, proteasome inhibitors and anti-CD38 monoclonal antibodies.
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Carvykti is specifically approved for patients with refractory or relapsed multiple myeloma who have received four or more prior lines of therapy, representing a population of patients that currently have no other treatment options available.
What makes Carvykti unique as a CAR-T therapy is that it utilizes the patient’s own T-cells to fight cancerous cells by reprogramming them to eliminate cells expressing BCMA, which is expressed on the surface of malignant multiple myeloma B-cell lineage cells. CAR-T therapy also drives long-lasting remission, making it an important scientific step towards eliminating certain cancers.
In the companies’ CARTITUDE-1 studies, Carvykti provided a deep and durable response rate in 98% of 97 patients. 78% of patients treated achieved stringent complete response, where no cancerous cells could be found in the body, and in December 2021, results showed that after a median follow-up of two years, 74% of those treated were still alive, with 61% having no further progression of their cancer.
“Multiple myeloma remains an incurable disease with heavily pretreated patients facing poor prognoses with limited treatment options,” said Ying Huang, Ph.D., CEO and CFO of Legend Biotech. “Today’s approval of CARVYKTI is a pivotal moment for Legend Biotech because it is our first-ever marketing approval, but what really excites us is the drug’s potential to become an impactful therapy option for patients in need of long, treatment-free intervals. This is the first of many cell therapies we plan to bring to patients as we continue advancing our pipeline across disease states.”
Carvykti, which is expected to become more widely available to oncologists and patients in the U.S. as 2022 progresses, is available only through a restricted program under a Risk Evaluation and Mitigation Strategy, a drug safety program that the FDA requires for certain medications with serious safety concerns.
Carvykti has a Boxed Warning cautioning possible Cytokine Release Syndrome, Immune Effector Cell-Associated Neurotoxicity Syndrome, Parkinsonism and Guillain-Barré syndrome, hemophagocytic lymphohistiocytosis/macrophage activation syndrome, and prolonged and/or recurrent cytopenia.
Although the treatment will be valuable to patients who are in need of options, the price of the therapeutic could amount to an insurmountable setback. Although J&J anticipates the therapy will be covered by most commercial insurers and Medicare, the list price of Carvykti is $465,000.
Financially, CAR-T therapies have come under scrutiny, with projected costs for patients sometimes exceeding $1 million.
In light of costs, The American Journal of Managed Care has proposed a framework to optimize and expand patient access to CAR-T therapies. The proposal includes improving the manufacturing process, decentralizing manufacturing, introducing price modulation, improving reimbursement strategies and improving partnerships between industry, academia, and community oncologic practices to foster research and patient-centric clinical data.
Only time will tell if these therapies will become more affordable and accessible to those who need them most.
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