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FDA lifts hold on AbbVie multiple myeloma study

  • The Food and Drug Administration has lifted a clinical hold on one multiple myeloma trial for AbbVie’s Venclexta after making several changes to the study protocols, the big biotech said Monday. 
  • The cancer drug’s multiple myeloma trials were suspended in March for safety concerns after a Phase 3 study showed the Venclexta arm had a higher rate of patient deaths than placebo. The hold remains effective for all other multiple myeloma trials besides CANOVA, with one federal database listing nine studies as suspended.
  • AbbVie said CANOVA’s updated protocol now includes new risk mitigation measures and an updated futility criteria. Enrollment has resumed for the Phase 3 study, which is testing Venclexta against Celgene’s Pomalyst in patients with relapsed or refractory multiple myeloma.

The incremental update shows some progress on working through the clinical hold from March. Venclexta (venetoclax) is jointly commercialized in the U.S. by AbbVie and Roche’s Genentech.

AbbVie has heralded the BCL-2 inhibitor as a key revenue driver for the pharma’s post-Humira future. In 2017, the company forecasted the drug will reach $6 billion in annual global sales in 2025.

Wall Street analysts aren’t quite as keen on the sales potential as AbbVie, but still anticipate blockbuster growth. Cowen & Co. analyst Ken Cacciatore, for instance, estimates growth to $2.75 billion in annual sales over the next five years.

To meet those expectations, Venclexta will need to keep expanding into new indications and earlier lines of treatment. Multiple myeloma is a valuable market, but AbbVie’s drug hit a major stumbling block this year with a concerning trend in patient deaths from the Phase 3 BELLINI study. 

That study randomized a group of about 300 multiple myeloma patients at a 2:1 ratio between Venclexta and placebo. While 21% of the Venclexta patients died, only 11% on placebo died, according to a safety analysis that led to the FDA’s clinical hold decision.

That regulatory action has slowed Venclexta’s progress in multiple myeloma, but resuming the CANOVA trial could help AbbVie get back on track.

Venclexta is also in clinical testing for non-Hodgkin’s lymphoma and myelodysplastic syndrome. 

Revenue from Venclexta more than doubled last year, reaching $344 million, as the drug notched expanded approvals in chronic lymphocytic leukemia and acute myeloid leukemia. The cancer treatment posted $151 million in net revenue for the first three months of 2019.