AbbVie and Roche just nabbed an FDA approval that spares certain relapsed leukemia patients chemotherapy—and could be key to $3 billion in peak sales to boot.
Their new blood cancer drug Venclexta, combined with oncology stalwart Rituxan, won a nod to treat chronic lymphocytic leukemia patients who’ve relapsed. The approval expands Venclexta’s reach considerably, because it applies to CLL patients with or without a genetic mutation known as the 17p deletion.
Plus, it’s the first oral, chemo-free cocktail that patients can stop taking after a course of treatment rather than taking it continuously, AbbVie pointed out on Friday, and it’s based on data showing that the Venclexta-Rituxan combo beat Rituxan paired with a standard chemotherapy, bendamustine. That study, presented in December at the American Society of Hematology (ASH) meeting, showed that the Venclexta-Rituxan duo cut the risk of disease worsening or death by 83% compared with the chemo combo.
“We’re pretty excited about what this means for what we can offer for patients,” Gary Gordon, AbbVie’s head of oncology development, told FiercePharma at ASH, referring to the option for patients to take their drugs for finite periods of time.
The current challenge in CLL is providing “patients with an option to have defined interventions for relatively short periods of time that can provide them sustained periods of relapse-free survival without having to take any drugs,” Gordon said. And what AbbVie’s hoping for “is that we build these combinations with Rituxan and other agents that give patients that sort of benefit."
Venclexta made its U.S. debut in 2016, when it was approved to treat only patients with the 17p deletion, seen in around 10% of all CLL cases and associated with a particularly poor prognosis. Leerink analyst Geoffrey Porges figures the new nod will drive Venclexta to $690 million in sales next year.
Long-term, the new approval is expected to help fuel growth to $1.5 billion to $2 billion in sales by the end of the decade. EvaluatePharma predicted last year that the drug would grow to $3 billion by 2022, putting it among the top-selling cancer drugs that year.
Venclexta is important to Roche and AbbVie both; they need to build up their portfolios ahead of biosimilar competition for their biggest drugs. Roche expects Rituxan biosims in the U.S. after 2019, putting $7 billion in sales at risk. Meanwhile, Herceptin knockoffs have already hit overseas, though Roche is doing its best to stall Samsung Biologics’ recently approved Herceptin knockoff in Europe.
AbbVie has more time to work with, thanks to a Humira biosim settlement with Amgen that delays its launch till 2023. The world’s best-selling med is expected to continue growing; AbbVie’s next-best seller is actually Imbruvica, which it markets in partnership with Johnson & Johnson and is studying in combination with Venclexta in CLL.