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
On Thursday, March 16, 2seventy bio released its Q4 and FY 2022 financial results (press release) highlighting Abecma’s (BCMA CAR-T) increased US revenue. Additionally, management did not provide major milestone updates for 2023, with Abecma’s sBLA filing to the FDA for ≥3L MM still expected in Q1 2023. On the same day, Gracell reported (SEC Filing) a license agreement with Seagen, under which Gracell will have WW licenses to certain patents for clinical and preclinical research, as well as commercialization, of cell therapy products. Below, Celltelligence provides insights on Abecma’s potential market growth for 2023, while discussing the license agreement between Gracell and Seagen.
EBMT – EHA CAR-T Meeting 2023 Analysis 2: BMS, Kite (Gilead), and Novartis presented clinical data and follow-up outcomes from their leading CAR-T therapies. Below, Celltelligence provides insights and context for key selected presentations. The following topics are covered below:
On Wednesday, October 26, BMS held its Q3 2022 earnings call (press release / presentation) highlighting an increase in revenue for Abecma (BCMA CAR-T) and Breyanzi (CD19 CAR-T). Additionally, management provided clinical updates for Abecma and noted the discontinuation of their NEX-T CAR-T programs. Below, Celltelligence provides insights on how Breyanzi and Abecma revenues compare with key competitors Kymriah (Novartis’s CD19 CAR-T), Yescarta (Gilead / Kite’s CD19 CAR-T), and Carvykti (JNJ / Legend’s BCMA CAR-T), while discussing the impact of BMS’s clinical updates in its strategy.
On Monday, October 3, Legend Biotech held their R&D Day (webcast), highlighting Carvykti’s (BCMA CAR-T) LCM initiatives, while providing updates on Legend’s pipeline platforms and programs. Below, Celltelligence provides insights on Carvykti’s ongoing competition with Abecma (BMS’s BCMA CAR-T), while evaluating the strength of Legend’s pipeline compared to its competitors.
On Wednesday, August 10, BMS and 2seventy bio reported positive topline results from Abecma’s (BCMA CAR-T) Ph3 KarMMa-3 trial in ≥3L MM (press release). Below, Celltelligence provides insights on how Abecma’s potential approval timeline in ≥3L MM compares with key competitor Carvykti (JNJ / Legend’s BCMA CAR-T).
On Tuesday, March 22, 2seventy bio released their Q4 2021 results (press release) highlighting their extended cash runway into 2025 and Abecma’s (BCMA CAR-T) potential FDA approval in ≥3L MM between 2023 – 2024. Of note, no major updates were provided for other pipeline assets. Below, Celltelligence provides insights on how 2seventy could leverage their extended cash runway, while comparing Abecma’s potential approval in ≥3L MM with key competitor Carvykti (JNJ / Legend’s BCMA CAR-T).