MM CAR-T 11:0 Passed! FDA Oncology Drug Advisory Committee Recommends Second-Line Indications For Carvykti
MM CAR-T 11:0 Passed! FDA Oncology Drug Advisory Committee Recommends Second-Line Indications For Carvykti
On March 16, 2024, Legend Biotech announced that the U.S. FDA Oncologic Drugs Advisory Committee (ODAC) unanimously recommended, with a vote of 11:0, the approval of CARVYKTI® (Ciltacabtagene Autoleucel, cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy (including a proteasome inhibitor and an immunomodulatory agent) and are refractory to lenalidomide.
Chinese report CARVYKTI treatment for MM has been approved as a second-line indication in the United States
Multiple myeloma is a difficult-to-treat malignant plasma cell disorder, accounting for approximately 10% of all hematological malignancies. It is estimated that in 2024, more than 35,000 people in the United States will be diagnosed with this disease, and more than 12,000 people will die from it.
Ciltacabtagene Autoleucel is a CAR-T therapy targeting B-cell maturation antigen (BCMA). It was approved by the U.S. FDA for marketing in February 2022, becoming the first domestically-developed CAR-T cell therapy approved by the FDA. In May 2022, it received conditional marketing authorization from the European Commission (EC), and in September, it was approved by the Japanese Ministry of Health, Labor, and Welfare (MHLW) for the treatment of adult patients with relapsed or refractory multiple myeloma, marketed under the brand name CARVYKTI®.
To date, 11 CAR-T therapies have been approved for marketing globally, with 6 approved in the United States and 5 approved in China.
The six CAR-T therapies approved in the United States are: Novartis’ Kymriah, Gilead’s Yescarta and Tecartus, Bristol-Myers Squibb’s Breyanzi and Abecma, and Legend Biotech/Johnson & Johnson’s Carvykti.
The five CAR-T therapies approved in China are:
Gilead/FosunKite’s Axicabtagene ciloleucel (RMB 1.2 million/dose);
JW Therapeutics’ Relmacabtagene Autoleucel (RMB 1.29 million/dose);
IASO Biopharma/Innovent Biologics’ Equecabtagene Autoleucel (RMB 1.166 million/dose);
Juventas’ Inaticabtagene Autoleucel (RMB 999,000/dose);
Carsgen Therapeutics’ Zevorcabtagene Autoleucel (RMB 1.15 million/dose).
Among these, Axicabtagene ciloleucel was introduced by FosunKite from Gilead’s subsidiary Kite Pharma in the United States in early 2017, and underwent technology transfer and authorization for local production in China. Relmacabtagene Autoleucel is a CAR-T product independently developed by JW Therapeutics based on JCAR017 from Juno Therapeutics in the United States.
Out of the 11 approved CAR-T therapies, only Carvykti, Abecma, Equecabtagene Autoleucel, and Zevorcabtagene Autoleucel are indicated for the treatment of multiple myeloma patients.
Among these, Carvykti has rapidly gained traction since its launch in 2022, generating sales of $134 million in 2022, and a staggering $500 million in 2023, representing a 276% year-over-year growth. It has the potential to become a blockbuster with sales exceeding $1 billion in the future.
In 2023, Abecma achieved sales of $472 million, a 22% year-over-year increase. Additionally, Equecabtagene Autoleucel was approved on June 30, 2023, but sales figures have not been disclosed yet. Zevorcabtagene Autoleucel was approved on March 1, 2024.
The positive recommendation from the FDA Oncologic Drugs Advisory Committee for CARVYKTI® has positive implications for the treatment of relapsed and refractory multiple myeloma patients, with the final decision on approval resting with the FDA.