FDA Expands J&J's (JNJ) Carvykti Label in Multiple Myeloma

Johnson & Johnson JNJ announced that the FDA granted label expansion to its multiple myeloma (MM) therapy Carvykti (ciltacabtagene autoleucel) for earlier lines of treatment. The therapy has been developed in collaboration with Legend Biotech Corporation LEGN.

Carvykti is now approved to treat adult patients with relapsed/refractory (r/r) MM who have received at least one prior line of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) and who are refractory to Bristol-MyersBMY Revlimid (lenalidomide).

The label expansion was expected as an FDA advisory committee unanimously recommended Carvykti for the second-line treatment of adults with r/r MM last month.

Both the recommendation and approval are based on survival and safety data from the late-stage CARTITUDE-4 study, which showed that the earlier use of Carvykti reduced the risk of disease progression or death by 59%, compared with the current standard of care treatments.

Year to date, J&J’s shares have lost 2.8% against the industry’s 12.4% increase.

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A B-cell maturation antigen (BCMA) CAR-T therapy, Carvykti was initially approved by the FDA in 2022 to treat adult patients with r/r MM who have received four or more prior lines of therapy, including a PI, an IMiD agent and an anti-CD38 monoclonal antibody. In the same year, the therapy was granted approval for a similar indication in Europe.

Prior to this label expansion, around 15% of patients initially diagnosed with MM were able to start a fifth line of therapy in the United States. With the new label, J&J and Legend Biotech expect to cater to a wider patient population. Management estimates that more than 35,000 cases of MM will be diagnosed in the United States alone this year.

To meet the increased demand for Carvykti following label expansion, J&J claims that it has more than doubled its manufacturing capacity last year.

J&J and Legend Biotech have also submitted a Type II variation application to the European Medicines Agency (EMA) seeking label expansion for Carvykti in the second-line setting. In February, the EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending Carvykti’s label expansion based on results from the CARTITUDE-4 study.

The new label also gives the J&J/Legend Biotech therapy an edge over Abecma, another FDA-approved CAR-T therapy in MM indication marketed by Bristol Myers in collaboration with 2seventy bio TSVT. Last week, the FDA granted label expansion to BMY/TSVT drug for the treatment of adults with r/r MM who have received two or more prior lines of therapy, including PI, an IMiD agent and an anti-CD38 monoclonal antibody. Like Carvykti, Bristol Myers/2seventy’s Abecma was previously cleared for use as a fifth-line treatment in the country.

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Zacks Rank

J&J currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks Rank #1 (Strong Buy) stocks here.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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