J&J and Legend Biotech Pause Carvykti Launch in the UK Amid Global Supply Constraints

Due to difficulties in meeting the demand for the CAR-T therapy Carvykti among American patients, Johnson & Johnson and its partner Legend Biotech seem to be adjusting the pace of their product rollout outside key markets.

The National Institute for Health and Care Excellence (NICE) is evaluating this novel treatment method for inclusion in the National Health Service (NHS). However, for now, Janssen has chosen not to seek approval from NICE.

The company did not specify the exact reasons for the delay in the launch of Carvykti. In its statement, Myeloma UK emphasized "supply issues" as global demand for all CAR-T therapies is increasing.

During the U.S. filing period for Carvykti, production limitations were well documented. Doctors complained about long waiting lists and a relatively high rate of manufacturing deviations. Despite strong demand, Carvykti’s sales remained steady at $55 million in both the third and fourth quarters of 2022.

Myeloma UK CEO Sophie Castell said in a statement that Johnson & Johnson's move was "undoubtedly a significant blow," and patients may soon seek other new treatments targeting the BCMA biomarker, including Pfizer's BCMAxCD3 bispecific antibody elranatamab.

Johnson & Johnson also has a BCMAxCD3 bispecific antibody. In August last year, the European Commission granted conditional approval to Johnson & Johnson's Tecvayli, which is also used for the treatment of relapsed and refractory multiple myeloma. The spokesperson said that Johnson & Johnson decided not to submit the drug for coverage assessment to NICE in December last year, so it is currently unclear when patients in the UK will have access to Tecvayli.

At the same time, Pfizer's elranatamab and GSK's BCMA antibody-drug conjugate Blenrep (withdrawn from the US market after a confirmatory trial failure) will undergo NICE evaluation this year, Myeloma UK noted.

As for another BCMA CAR-T drug, BMS's Abecma, its NICE evaluation process seems to have stalled as early as 2020. Myeloma UK stated that due to several factors, including the impact of the pandemic on clinical trial supplies, BMS put Abecma's launch plan in the UK on hold at that time.

Elsewhere in Europe, Johnson & Johnson received conditional approval from the European Commission in May to launch Carvykti in Germany. The spokesperson said that, as in the United States, Johnson & Johnson is taking a "phased approach" to launching certified treatment centers.

To address manufacturing limitations, Legend Biotech announced a plan in October last year to double its investment in a shared cell therapy manufacturing facility owned by Johnson & Johnson in Raritan, New Jersey. The partners are also building another facility in Ghent, Belgium. Despite significant investment, a Johnson & Johnson spokesperson did not provide a specific timeline for resolving the capacity shortage.

At the same time, after Abecma and Carvykti triumphed in recent Phase III clinical trials, they are expected to expand their indications to treat more patients with early-stage myeloma. Nevertheless, due to insufficient available production capacity, doctors may reserve cell therapy for patients who have no other options left.

References:

J&J shelves Carvykti's UK launch amid manufacturing shortfalls (fiercepharma.com)

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