AbbVie and Johnson & Johnson got a scare this Halloween, and it came in the form of an FDA approval for AstraZeneca’s Imbruvica rival—along with a list price that undercuts the established med.
On Tuesday, the FDA greenlighted BTK inhibitor Calquence as a treatment for adults with mantle cell lymphoma (MCL) who've received at least one prior therapy. The accelerated approval follows a breakthrough designation that AstraZeneca received just this August on the basis of strong phase 2 data.
Now, Calquence will go head to head with AbbVie and J&J’s blood cancer blockbuster—and the way analysts see it, the partners have reason to worry. The newcomer recorded an overall response rate of 81% in MCL compared with 66% for Imbruvica.
Complete response rates were "notably higher," too, at 40% versus Imbruvica's 17%, Leerink Partners' Seamus Fernandez wrote in a note to clients, though he cautioned that "these comparisons are based on a relatively small number of patients." Evercore ISI's Josh Schimmer added the disclaimer that "Imbruvica’s trial had a harder-to-treat population."
But Calquence has some other points in its favor, too. The AZ med is priced at a discount to its nemesis, with a list price of $14,259 per month; Imbruvica's checks in at $14,804. And Calquence is dosed twice a day instead of once, which "may lead to better adherence," Schimmer wrote in his own investor note.
Plus, the Calqence label lacks some specific warnings and precautions that Imbruvica's bears, for hypertension, tumor lysis syndrome, and embryo-fetal toxicity, Fernandez noted. Its prescribing information does, however. contain a warning against taking Calquence with proton-pump inhibitors. while Imbruvica's doesn't.
AZ certainly hopes Calquence can make those differences pay off. The British drugmaker gained access to Calquence in 2015, thanks to a $4 billion-plus deal with developer Acerta. And to that payoff, AstraZeneca isn’t stopping with MCL. It’s currently gunning for a Calquence nod in chronic lymphocytic leukemia, a larger market opportunity, and it's hoping those trial advantages hold up for Calquence in an ongoing, phase 3 CLL trial pitting it directly against the AbbVie-J&J star.
Meanwhile, Tuesday’s FDA blessing provides a needed boost for AstraZeneca’s oncology sales ambitions. Over the summer, the drugmaker’s closely watched immuno-oncology combo trial in first-line lung cancer came up short, throwing sales forecasts for its PD-L1 checkpoint inhibitor Imfinzi in doubt. AZ also recently struck a pact with Merck forking over half the rights to PARP standout Lynparza—and half the drug's potential sales.
“In what appears to be an admission of defeat in the initial I-O race, this agreement gives away half of Lynparza profits in order for AstraZeneca to take advantage of Keytruda’s broad development,” Fernandez wrote to clients at the time.
Editor's note: This story was updated with pricing and comments from analysts.