Abecma’s Regulatory Applications for R/R MM Accepted in the US, Europe, and Japan
Abecma’s Regulatory Applications for R/R MM Accepted in the US, Europe, and Japan
Abecma’s Regulatory Applications for R/R MM Accepted in the US, Europe, and Japan
It’s great to be back in 2023 serving our growing audience! Ahead of JPM Week, there were a few cell therapy-related news items:
On Tuesday, September 27, Legend announced (press release) that Japan’s Ministry of Health, Labour, and Welfare (MHLW) approved Carvykti (BCMA CAR-T) for the treatment of ≥4L r/r MM. Below, Celltelligence provides insights on how Carvykti’s approval may challenge Abecma’s (BMS’s BCMA CAR-T) first-to-market advantage in Japan, while discussing Carvykti’s potential pricing.
On Friday, August 26, Japan’s Ministry of Health Labour and Welfare (MHLW) approved Kymriah (Novartis’s CD19 CAR-T) for the treatment of r/r FL (press release). Below, Celltelligence provides insights on Kymriah’s potential pricing reduction in Japan, while discussing Novartis’s cell therapy expansion in the APAC market.
AACR 2022 Final Analysis: Several preclinical results were presented from Fate Tx, and Shoreline. Additionally, a cell therapy-related piece of news was observed, with Abecma set to become reimbursed in Japan after joining the NHI’s reimbursement price list on April 20, 2022. Below, Celltelligence provides insights and context for each presentation. The following topics are covered below:
BMS recently announced (press release) that Japan’s Ministry of Health, Labour and Welfare (MHLW) accepted Breyanzi’s (CD19 CAR-T) sNDA in 2L LBCL. Below, Celltelligence provides insights on Breyanzi’s potential approval timeline for 2L LBCL in Japan, while discussing possible reimbursement issues as the CD19 CAR-T moves into earlier lines of therapy.
On Friday, March 25, BMS announced (press release) that Japan’s Ministry of Health, Labour and Welfare (MHLW) has accepted Breyanzi’s (CD19 CAR-T) sNDA for 2L DLBCL. Of note, the acceptance is based on results from Breyanzi’s Ph3 TRANSFORM trial. The Celltelligence team will be conducting a full thoughts-on analysis and provide potential approval timelines in the coming days.
On Thursday, January 20, BMS announced (press release) that Japan’s Ministry of Health, Labour and Welfare (MHLW) approved Abecma (BCMA CAR-T) for the treatment of ≥4L r/r MM. Moreover, a new clinical study evaluating the feasibility of a Digital Health Coaching Program for individuals who have received CAR-T therapy was observed on CT.gov. Of note, Pack Health is the sponsor of the trial with Novartis and Ohio State University Comprehensive Cancer Center appearing as collaborators. Below, Celltelligence provides insights on Abecma’s potential market access in Japan, while commenting on how the current viral vector shortage could limit BMS’s ability to deliver Abecma in Japan.
On Thursday, December 16, Gilead (Kite) announced (press release) that Daiichi Sankyo has authorized Yescarta’s (Gilead’s CD19 CAR-T) first treatment center in Japan. Below, Celltelligence provides insights on how Yescarta’s footprint in Japan may potentially increase Gilead’s (Kite) WW market revenue, while discussing differences in ATC onboarding rates between the US and Japan.
On Monday, December 6, Japan’s Pharmaceutical Affairs and Food Sanitation Council (PAFSC) granted Abecma (BMS’s BCMA CAR-T) a positive opinion (press release, PharmaJapan, Dec 2021). Below, Celltelligence provides insights on Abecma’s potential approval and reimbursement timeline in Japan.