On Friday, the FDA gave the green light to Johnson & Johnson‘s Carvykti, marking a significant advancement in the realm of blood cancer treatment. Carvykti, also known as ciltacabtagene autoleucel or cilta-cel, is now approved for relapsed or refractory multiple myeloma patients who have previously undergone at least one line of therapy and are refractory to lenalidomide.
The unanimous 11 to 0 vote from the FDA’s Oncologic Drugs Advisory Committee underscores their support for Carvykti’s favorable risk-benefit profile, based on data from the Phase 3 CARTITUDE-4 study.
This nod from the FDA propels Carvykti to the forefront as the first and only B-cell maturation antigen (BCMA)-targeted therapy sanctioned for treating patients with multiple myeloma starting from their first relapse.
The Phase 3 CARTITUDE-4 trial evidence showed a 59% reduction in the risk of disease progression or death with early Carvykti use compared to standard treatments, further solidifying its efficacy.
Tyrone Brewer, President of U.S. Hematology at Johnson & Johnson Innovative Medicine, expressed the company’s commitment to meeting the demand for Carvykti, emphasizing an ongoing increase in production capacity to ensure broad patient accessibility.
In a strategic move back in December 2017, Johnson & Johnson struck an exclusive global license and collaboration deal with Legend Biotech Corporation to co-develop and commercialize Carvykti, cementing a vital partnership in advancing cancer care.
William Blair highlights the extended collaboration between Legend Biotech Corporation and Johnson & Johnson with Novartis AG until 2029, focusing on ramping up Carvykti’s commercial production capacity.
With a target to double manufacturing efforts by 2024 and achieve at least 10,000 manufacturing slots by 2025, this expansion drive sets a crucial milestone in the CAR-T therapy domain, particularly with Carvykti’s endorsement for second-line use, broadening patient eligibility and reinforcing CAR-T as a potent early-line therapy.
While Carvykti currently leads the pack in therapy effectiveness, the multiple myeloma treatment market harbors a plethora of contenders. The emergence of newer BCMA-targeted competitors with enhanced manufacturing consistency or immediate availability could potentially challenge Carvykti’s dominant market position and revenue trajectory.
Price Action: JNJ shares exhibit a modest 0.15% dip at $152.17, while LEGN shares show a 1.19% decrease at $54.28 on the trading floor this Monday.
Photo via Shutterstock