AbbVie Inc’s experimental lung cancer drug data was not effective enough to seek a faster approval, in a setback to the company’s efforts to build its cancer drug pipeline and cut dependence on its blockbuster Humira.
The company said on Thursday it would not seek accelerated approval for the drug, Rova-T, after consulting with the U.S. Food and Drug Administration based on “magnitude of effect across multiple parameters”.
“You’ve got okay response rate, no evidence that there are long-term survivors and then you have a pretty onerous side effect burden,” Leerink Partners analyst Geoffrey Porges told Reuters.
The mid-stage study tested Rova-T as a treatment for small cell lung cancer patients who failed to respond to at least two prior regimens.
Rova-T, which AbbVie acquired with its $5.8 billion purchase of Stemcentrx in 2016, is expected to generate sales of $1.2 billion in 2023, according to Thomson Reuters estimates.
“(AbbVie) needs something that is the cornerstone of the oncology franchise that they own and Rova-T was meant to be that,” Porges said. “And now that cornerstone is cracked you wonder if they don’t have to go out and find something else.”
Late-stage trials testing the drug as a treatment for patients who have either failed to respond to initial treatment or are newly diagnosed will continue, the company said.
Rova-T is a toxic chemical that is loaded onto an antibody to target a protein called DLL3 found in more than 80 percent of patients with cancer.
The FDA’s accelerated approval program is meant for drugs that treat serious conditions based on a marker that is expected to lead to a clinical benefit.
Guggenheim Securities analyst Tony Butler said AbbVie will likely have to run a bigger trial that will cost more and will need to have a control arm.
“They wanted to do this with a relatively small number of patients and not have to run a control or a big study. That strategy is now thrown out.”
(Reporting by Tamara Mathias and Ankur Banerjee in Bengaluru; Editing by Anil D’Silva)