Tag Archives: AdCom

Sales of Carvykti Continue to Grow; FDA and EMA Advisory Committees Will Review Carvykti Applications for Early MM; JNJ Considers Entering in Autoimmune Diseases; JNJ’s Q4 2023 Earnings Call Summary

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.

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Abecma sBLA to Face FDA AdCom; PDUFA Date Delayed; Could Carvykti Be Approved Before Abecma in Earlier Lines of MM?

On Monday, November 20, BMS / 2seventy bio announced (press release) that the FDA Oncologic Drugs Advisory Committee (ODAC) will meet to review data supporting the sBLA for Abecma (BCMA CAR-T) in triple-class exposed MM. Importantly, the companies disclosed the FDA will not meet the PDUFA date originally set for December 16, 2023. Below, Celltelligence provides insights on the possible reasons behind the FDA’s decision, while discussing potential timelines for the ODAC meeting and the new PDUFA date.

About The Author

The Celltelligence Team

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Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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