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Chronic Lymphocytic Leukaemia (CLL): Update Bulletin #1 [November 2018]

Product Code:
Publication Date:
November 2018

This edition presents the views and insights from three world leading key opinion leaders (KOLs) from North America and Europe on a variety of recent events in the chronic lymphocytic leukaemia (CLL) market, including:the CHMP’s positive opinion of the Venclyxto and MabThera combination for previously-treated CLL patients; TG Therapeutics’ decision to focus on progression-free survival (PFS) primary endpoint to support full approval of the ublituximab and umbralisib combination for CLL; AbbVie seeking FDA approval for Imbruvica in combination with Gazyva for previously untreated adult patients with CLL or small lymphocytic lymphoma.

Business Questions:

• Will dual-therapy, Venclexta/Venclyxto and Rituxan/MabThera, be positively received in the EU?
• What impact will adding minimal residual disease (MRD)-negativity data to its label, have on Venclexta/Venclyxto?
• Is there an appetite for a standardised MRD test? BP4
• What barriers to success will the combination of Venclexta/Venclyxto and Rituxan/MabThera face?
• Is the decision to no longer seek accelerated approval for ublituximab plus umbralisib (U2) a major setback for TG Therapeutics?
• Are KOLs confident that U2 will prove itself in the UNITY-CLL trial?
• Where in the treatment paradigm will U2 be of most use?
• Do KOLs expect the combination of Imbruvica and Gazyva to be approved?
• What are the experts’ key concerns around iLLUMINATE’s trial design?
• How convinced are the KOLs that Imbruvica plus Gazyva will be a success?


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