Fierce Pharma April 8, 2024
Angus Liu

Merely hours after Bristol Myers Squibb’s Abecma secured the FDA’s blessing to break into earlier treatment of multiple myeloma, Johnson & Johnson and Legend Biotech’s Carvykti received a similar go-ahead—but in an even earlier setting and with expanded manufacturing specifications.

With an approval Friday, Carvykti has become the first BCMA-directed therapy for multiple myeloma patients who have received at least just one prior line of therapy. To be eligible, a patient’s cancer must be refractory to BMS’ Revlimid, mirroring the population enrolled in the CARTITUDE-4 trial, which supported the recent Carvykti filing.

Moving into the second line represents a key step in J&J’s plan to make Carvykti a $5 billion-plus product at peak sales. Last year, the drug pulled in...

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Topics: Biotechnology, FDA, Govt Agencies, Pharma / Biotech
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