CHMP Adopts Positive Opinion for Abecma in ≥3L MM; January CHMP Highlights
On Friday, January 26, the CHMP meeting highlights were released, including the positive opinion of the CHMP for Abecma (BMS’s BCMA CAR-T) in ≥3L MM.
On Friday, January 26, the CHMP meeting highlights were released, including the positive opinion of the CHMP for Abecma (BMS’s BCMA CAR-T) in ≥3L MM.
On Tuesday, January 23, JNJ held its Q4 and FY2023 earnings call (press release / presentation) highlighting Carvykti’s (BCMA CAR-T) revenue growth. On the same day, Legend disclosed (SEC filing) that advisory committees of the FDA and the EMA will meet to discuss the applications for using Carvykti in ≥2L MM.
On Monday, January 22, the CHMP agenda for January was released including Abecma (BMS / 2seventy bio’s BCMA CAR-T) in the ‘Type II Variations – Opinions or Requests for Supplementary Information’ section for ≥3L MM, while the Carvykti (JNJ / Legend’s BCMA CAR-T) Type II Variation for ≥2L MM was absent from the agenda.
On the third day of JPM 2024, Celltelligence covered Allogene’s event (presentation / webcast). Below, Celltelligence provides insights and context to the presentation covering the following topics:
On the second day of JPM 2024, Celltelligence covered presentations by Legend (presentation / webcast), AstraZeneca (presentation / webcast), and BioNTech (presentation / webcast). Below, Celltelligence provides insights and context for each presentation. The following topics are covered below:
On the first day of JPM 2024, Celltelligence covered presentations by BMS (presentation / webcast), Gilead (presentation / webcast), Novartis (presentation / webcast), and JNJ (webcast). Below, Celltelligence provides insights and context for each presentation. The following topics are covered below:
On Friday, December 15, the CHMP meeting highlights were released. Of note, Carvykti (JNJ / Legend’s BCMA CAR-T) was absent from the CHMP highlights, implying that the Type II Variation (T2V) for its approval in ≥2L MM has received a second Request for Supplementary Information (RSI). Moreover, recall that the Abecma (BMS / 2seventy’s BCMA CAR-T) T2V in ≥3L MM was not included on Monday’s CHMP agenda. Below, Celltelligence provides insights on the December CHMP meeting with updated EU timelines for both cell therapies, while discussing the possible timeline for obe-cel accelerated assessment.
ASH 2023 Analysis 7: BMS / 2seventy and JNJ / Legend presented analyses from their BCMA CAR-Ts in early line MM. Below, Celltelligence provides insights and context for key selected presentations. The following topics are covered below:
ASH 2023 Analysis 3: Gilead (Kite) and BMS presented real-world (RW) and clinical data updates in r/r LBCL. Below, Celltelligence provides insights and context for key selected presentations. The following topics are covered below:
ASH 2023 Analysis 1: BMS and Autolus presented clinical updates from their programs in MM. Below, Celltelligence provides insights and context for key selected presentations. The following topics are covered: