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CLL: Update Bulletin #3 [May 2018]

Product Code:
Publication Date:
May 2018

This edition presents key opinion leader (KOL) views on recent developments in the chronic lymphocytic leukaemia (CLL) market. Topics covered include: Gilead’s recent withdrawal of the marketing authorisation application (MAA) to the EMA to expand use of its PI3 kinase (PI3K) delta inhibitor Zydelig (idelalisib) in combination with the Rituxan/MabThera (rituximab) and bendamustine (BR) regimen for the treatment of patients with CLL; Verastem announcing that the US FDA had accepted for filing with Priority Review its New Drug Application (NDA) for its lead PI3K inhibitor candidate duvelisib based on positive results from the Phase III DUO study; Johnson & Johnson (J&J) and AbbVie announcing that they will implement a new pricing and dosage scheme for their Bruton’s tyrosine kinase (BTK) inhibitor Imbruvica (ibrutinib) ahead of research suggesting the drug would work just as well at lower doses.

Business Questions:

  • How do KOLs view Gilead’s application withdrawal in Europe to expand the use of Zydelig in combination with BR?
  • What are KOLs’ updated thoughts on Zydelig as a treatment approach in CLL?
  • How is Zydelig’s prescribing likely to evolve going forward given strong competitors such as AbbVie/Roche’s Venclexta/Venclyxto (venetoclax) are on the market?
  • Based on the positive data published in the DUO study, how do KOLs compare and contrast duvelisib with Zydelig in terms of efficacy and safety? Will further long-term follow-up be needed?
  • In light of the positive results published for the DUO study, do KOLs anticipate the approval and uptake of duvelisib as a treatment for CLL?
  • How do the experts view the new dosing scheme proposed for Imbruvica? What are their main concerns about the new dosing formulation, if any?
  • Will a one pill formulation of Imbruvica potentially improve patient compliance?
  • Will the proposed new dosing scheme have any impact on the prescribing of Imbruvica going forward?
  • What are KOLs’ other main concerns about Imbruvica as a treatment option in CLL?
  • Novel BTK inhibitors (AstraZeneca’s acalabrutinib and Beigene’s zanubrutinib) are both in Phase III development; will they be able to compete with Imbruvica? What are KOL expectations for these novel agents?


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