As Johnson & Johnson and partner Legend Biotech struggle to meet demand for their CAR-T therapy Carvykti in the U.S., the companies seem to be pacing themselves with launches outside of the key market.
J&J’s Janssen has decided not to launch Carvykti in the U.K., for now, and has withdrawn from a reimbursement assessment process in the country, the charity group Myeloma UK said Monday.
A J&J spokesperson confirmed the withdrawal to Fierce Pharma, saying the company is “not currently in a position to progress through” the coverage appraisal process for Carvykti in heavily pretreated myeloma. Carvykti’s clinical trial program in the U.K. isn’t affected, the spokesperson added.
The company didn’t specify an exact reason for its decision to push back Carvykti’s launch. In its statement, Myeloma UK highlighted “issues with the supply” amid increased global demand for all CAR-T therapies.
“[I]t is believed that it is not going to be possible to produce the supply needed to support a program in the U.K.,” the organization said.
Manufacturing constraints have been well documented for Carvykti during its ongoing U.S. launch. Doctors have complained about the drug’s long waiting list and relatively high rate of production deviations. Despite the strong demand, Carvykti’s sales plateaued at $55 million in both the third and fourth quarters of 2022.
Characterizing J&J’s move as “undeniably a major blow,” Myeloma UK’s chief executive Sophie Castell said in a statement that patients might seek other new treatments that also target the BCMA biomarker in the near future, including Pfizer’s investigational BCMAxCD3 bispecific elranatamab.
For its part, J&J also has a BCMAxCD3 bispecific antibody. In August, the European Commission granted a conditional nod to J&J’s Tecvayli, also for relapsed and refractory multiple myeloma. J&J in December decided against submitting the drug to the U.K.’s National Institute for Health and Care Excellence (NICE) for coverage evaluation, the spokesperson said, so it isn’t clear when Tecvayli might be available to U.K. patients.
Meanwhile, Pfizer’s elranatamab and GSK’s BCMA-directed antibody-drug conjugate Blenrep—which has been pulled from the U.S. after a confirmatory trial flop—are up for NICE evaluations this year, Myeloma UK noted.
As for the other BCMA CAR-T drug, Bristol Myers Squibb’s Abecma, its own NICE appraisal process appeared stalled back in 2020. BMS shelved its Abecma U.K. launch plan at that time because of several factors, including the impact of the pandemic on clinical trial supplies, Myeloma UK said.
Elsewhere in Europe, J&J has launched Carvykti in Germany after conditional authorization from the European Commission in May. Like in the U.S., J&J is taking a “phased approach” to activating certified treatment centers, the spokesperson said.
Trying to tackle the manufacturing constraints, Legend Biotech in October unveiled a plan to double its investment in a J&J-shared cell therapy manufacturing facility in Raritan, New Jersey. The partners are also building another factory in Ghent, Belgium. Despite the significant investments, J&J’s spokesperson wouldn’t give an exact timeline for resolving the production shortfall.
Meanwhile, after recent phase 3 wins, both Abecma and Carvykti could be on track for label expansions to treat more myeloma patients in earlier lines of treatment. Still, without enough readily available capacity, doctors would likely save the cell therapies for those who’ve run out of options.