An FDA advisory committee will meet to review J&J and Legend Biotech’s supplemental BLA for Carvykti for the treatment of relapsed or refractory multiple myeloma patients who have undergone at least one prior line of therapy.
Pictured: Johnson & Johnson’s office in Spain/iStock, BrasilNut1
Legend Biotech announced in an SEC filing on Tuesday that the FDA will convene its Oncologic Drugs Advisory Committee to discuss the use of its Johnson & Johnson-partnered Carvykti (ciltacabtagene autoleucel) in earlier lines of treatment for multiple myeloma.
The panel of external experts will evaluate J&J and Legend’s data in the Phase III CARTITUDE-4 study, which positions Carvykti as a treatment option for patients with relapsed and lenalidomide-refractory multiple myeloma who had received at least one previous line of systemic therapy, including an immunomodulatory agent and a proteasome inhibitor.
Currently, Carvykti is indicated for patients with at least four prior lines of therapy.
The meeting’s schedule has yet to be determined but will be announced in the Federal Register, according to Legend’s SEC filing.
The European Medicines Agency’s Committee for Advanced Therapy will also hold a Scientific Advisory Group Oncology meeting to discuss Carvykti’s similar expansion into an earlier-line setting.
Carvykti is a CAR-T therapy targeting the BCMA protein and was approved in February 2022 for the treatment of heavily pretreated relapsed or refractory multiple myeloma. In June 2023, Legend and J&J submitted a supplemental Biologics License Application to the FDA, seeking to initiate Carvykti treatment earlier in a patient’s disease course, after at least one prior line of therapy.
Carvykti’s push to earlier-line settings has been marred by the FDA’s probe into the overall safety of CAR-T therapies. In November 2023, the regulator first announced that it was looking into reports of patients who had developed secondary T-cell malignancies after being treated with these medicines. At the time, the regulator said that patients who had received CAR-T treatment, including through clinical trials, “should be monitored life-long for new malignancies.”
Last week, the FDA wrote to the manufacturers of all six commercial CAR-T therapies—including J&J and Legend—that their products need to include a boxed warning reflecting their risk of secondary cancers. Carvykti’s label already reflects these risks.
Despite the regulatory hurdles, J&J appears to be confident in the commercial prospects of the CAR-T therapy—which raked in $500 million in sales last year—while announcing a manufacturing ramp-up on Tuesday during its fourth-quarter 2023 earnings report.
“We are already manufacturing the first batches of Carvykti for clinical use this month of January,” J&J CEO Joaquin Duato said during an investor call. “We have also contracted additional capacity … to scale up production and increase our ability moving forward that will start mid this year.”
“Overall, we feel good that we are progressing with Carvykti,” Duato continued, adding that the company is confident that it can deliver quarter-over-quarter growth this year.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
