- AbbVie and Swiss pharma partner Roche on Friday won an important U.S. approval for a combination regimen pairing their blood cancer drug Venclexta with Roche's older medicine Rituxan, boosting expectations of broader uptake.
- The Food and Drug Administration OK'd the two drugs for use in previously treated patients with either chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) — related cancers that are diagnosed in, respectively, 20,000 and 5,000 U.S. patients each year.
- Venclexta initially launched in the U.S. two years ago as a treatment for a subset of CLL patients with a chromosomal defect known as 17p deletion. The FDA's nod last week converted that accelerated OK into a full approval.
Venclexta (venetoclax)'s approval in relapsed or refractory CLL patients could help speed adoption of the drug, which has so far been limited by the narrow label among patients with 17p deletion.
Sales, which are booked by AbbVie but shared with Roche in the U.S., totaled $59 million in the first quarter of 2018. Analysts expect sales to quicken as the partners work to expand the drug's addressable market. AbbVie is even more bullish, suggesting $6 billion in global revenues from the drug by 2025, according to Cowen analyst Steve Scala.
The second-line approval is the next step toward that lofty goal. In the near-term, however, uptake could be moderated somewhat by use of AbbVie's own drug Imbruvica (ibrutinib).
"Imbruvica has over 70% share of the [relapsed/refractory] setting so adoption of Venclexta may be gradual as Imbruvica use shifts to [first-line use]," wrote Evercore ISI analyst Josh Schimmer in a note to investors earlier this year.
In Venclexta's favor are impressive clinical results that show it can ably replace the chemotherapy bendamustine in a Rituxan (rituximab)-based combo regimen. Data from a study called MURANO found Venclexta plus Rituxan cut the risk of disease progression or death by 81% compared to bendamustine plus Rituxan in second-line CLL or SLL.
Imbruvica notched similarly impressive results in the second-line setting, although the relevant trials compared the Bruton's tyrosine kinase (BTK) inhibitor to other comparator treatments.
The converted approval from the FDA also clears use of Venclexta as a monotherapy in second-line CLL or SLL patients with or without 17p deletion.
And Imbruvica is now OK'd in the first-line setting, giving AbbVie a strong presence in CLL and SLL across lines of treatment.
AbbVie and Roche are developing Venclexta combined with Roche's Gazyva (obinutuzumab) in first-line CLL, and with various other drugs in multiple myeloma, acute myeloid leukemia and diffuse large B-cell lymphoma.