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CAR-T Therapy in Haematological Malignancy: Update Bulletin #1 [July 2018]

Product Code:
Publication Date:
July 2018

This edition presents leading US and EU key opinion leader (KOL) views on recent developments in the CAR-T therapies space. Topics covered include expert opinions on the FDA approval of Novartis’ Kymriah (tisagenlecleucel-T; CTL019) for the treatment of patients with adult diffuse large B-cell lymphoma (DLBCL) and the longer follow-up data presented at the 2018 American Society of Clinical Oncology (ASCO) meeting for Kymriah and Kite/Gilead’s Yescarta (axicabtagene ciloleucel; KTE-C19). Experts offer their opinions on the recent positive recommendation from the EMA’s CHMP regarding the two CAR-T products. KOLs also discuss updated data reported at ASCO for Juno Therapeutics/Celgene’s JCAR017 in the TRANSCEND-NHL study and offer their candid insights on the results presented for bluebird bio/Celgene’s anti-BCMA CAR-T therapy bb2121 in patients with heavily pre-treated relapsed/refractory multiple myeloma.

Business Questions:

• How do the KOLs view Kymriah’s recent FDA approval in DLBCL and how will it impact real-world usage?
• According to the KOLs, how are Kymriah and Yescarta faring on the US market so far? How are physicians currently selecting patients for treatment with either CAR-T product?
• Given the longer term follow-up data presented at ASCO 2018, how do KOLs compare and contrast Kymriah and Yescarta in terms of efficacy and safety?
• What are KOL opinions on the updated data presented for JCAR017 in the TRANSCEND-NHL study?
• How does JCAR017 match up to Kymriah and Yescarta so far in terms of efficacy, safety and manufacturing? Will JCAR017 be able to secure a foothold in the competitive space?
• What are KOLs expectations for the EMAs’ decision on Kymriah and Yescarta? What negotiations will need to be reached in Europe to ensure patient access to these therapies?
• Going forward, what key factors will impact real-world uptake and usage of the key CAR-T products?
• How important will safety, ease-of-use, production turnaround and physician familiarity/experience be in determining uptake and use?
• How do the experts view the updated dataset presented at ASCO 2018 for bluebird/Celgene’s bb2121? Is this approach likely to be curative in multiple myeloma?
• From a safety standpoint, how do the KOLs view bb2121?
• Does bb2121 have potential for earlier usage in patients with multiple myeloma?


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