Benzinga - by Vandana Singh, Benzinga Editor.
Friday, the FDA approved Johnson & Johnson (NYSE:JNJ) Carvykti (ciltacabtagene autoleucel; cilta-cel) for relapsed or refractory multiple myeloma patients who have received at least one prior line of therapy and are refractory to lenalidomide.
FDA’s Oncologic Drugs Advisory Committee unanimously votes 11 to 0, supporting the favorable risk-benefit assessment of Carvykti based on results from the Phase 3 CARTITUDE-4 study.
With this approval, Carvykti becomes the first and only B-cell maturation antigen (BCMA)-targeted therapy approved for the treatment of patients with multiple myeloma as early as the first relapse.
FDA approval is based on results from the Phase 3 CARTITUDE-4 study, which demonstrated that the earlier use of Carvykti reduced the risk of disease progression or death by 59% compared to standard therapies.
“We understand the urgency for patients in need of Carvykti, and we have been making considerable progress in increasing supply and availability in anticipation of this milestone approval,” said Tyrone Brewer, President, U.S. Hematology, Johnson & Johnson Innovative Medicine. “We more than doubled manufacturing of Carvykti in 2023, we are striving to double again in 2024, and we will continue to invest in our capacity so we can provide this critical therapy to as many patients as possible.”
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In December 2017, Johnson & Johnson entered into an exclusive worldwide license and collaboration agreement with Legend Biotech Corporation (NASDAQ:LEGN) to develop and commercialize Carvykti.
William Blair notes that Legend (Market Perform rating) and Johnson & Johnson have extended their agreement with Novartis AG (NYSE:NVS) until 2029, focusing on producing commercial batches of Carvykti.
The collaboration aims to double Carvykti’s manufacturing efforts by 2024 and achieve a minimum of 10,000 manufacturing slots by 2025.
This expansion is seen as a significant milestone for the CAR-T space, particularly with Carvykti’s approval in the second-line setting, which broadens the scope of eligible patients and strengthens CAR-T as an effective early-line therapy.
The analyst notes Carvykti currently leads in therapy effectiveness, and the market for multiple myeloma treatments is sizable, accommodating numerous competitors. However, newer BCMA-targeted products with improved consistency in manufacturing or ready-made availability could potentially reduce Carvykti’s market dominance and affect its revenue over time.
Price Action: JNJ shares are down 0.15% at $152.17, and LEGN shares are down 1.19% at $54.28 on Monday.
Photo via Shutterstock
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| Jan 2022 | Morgan Stanley | Maintains | Equal-Weight | |
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