Trial Watch: AbbVie’s IMBRUVICA® Data in CLL Show Up to 7-Years of PFS in 80% Untreated Patients

AbbVie’s IMBRUVICA

AbbVie secured ownership of IMBRUVICA® (ibrutinib) in 2015 when it purchased Pharmacyclics. AbbVie reported $2.5 billion in sales with a robust 40% growth rate.  It was created by scientists at Celera Genomics as a tool compound for studying BTK function and then developed by Pharmacyclics up to Phase II. The Wall Street Journal reported in 2016 that the drug cost US $116.6K to $155K wholesale in the United States. The drug is used to treat chronic lymphocytic leukemia, Waldenstrom's macroglobulinemia and chronic graft vs. host disease.

AbbVie recently announced up to seven years of clinical trial follow-up for IMBRUVICA® monotherapy in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), the longest follow-up for a Bruton's tyrosine kinase (BTK) inhibitor to date. The updated Phase 1b/2 data demonstrated durable responses in CLL/SLL patients with an overall response rate (ORR) of 89 percent. Evaluated patients included those with high-risk genomic factors such as complex karyotype and unmutated IGHV, and more than 70 patients with three to 12 prior lines of therapy. Progression-free survival (PFS) rates were also sustained (estimated seven-year rates of 80% for pr...

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