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, Autolus announced (press release) that the FDA accepted its BLA for obe-cel (AUTO1, CD19 CAR-T) BLA for the treatment of adult r/r B-ALL. Notably, the regulatory agency did not grant Priority Review, setting a PDUFA date of November 16, 2024.
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 fourth and last day of JPM 2024, Celltelligence covered Adaptimmune (webcast / presentation) and Caribou (webcast / presentation). Below, Celltelligence provides insights and context to the presentation covering the following topics:
On the second and third days of JPM 2024, Celltelligence covered presentations by Imugene (webcast / presentation), CRISPR Tx (press release / webcast), and Precigen (webcast / presentation). Below, Celltelligence provides insights and context for each presentation. The following topics are covered:
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 Thursday, January 4, Poseida provided business updates and future milestones for its allogeneic cell therapy programs (press release). On the same day, Adaptimmune disclosed its plans for its sarcoma pipeline (press release), disclosing its plans to continue developing lete-cel (NY-ESO-1 TCR-T) and to seek approval for its second asset, with an expected US launch in 2026.