AbbVie, Roche aim to face down Pfizer with Venclexta’s move into AML arena

AbbVie and Roche’s Venclexta is leaving familiar territory with its latest approval, and it won’t be an easy land grab. To establish itself on its new turf, the blood cancer drug will have to duke it out with some Big Pharma rivals.

The drug has snagged an FDA approval in acute myeloid leukemia, winning clearance last week in combination with any of three chemo options to treat newly diagnosed patients aged 75 or older or those who aren’t eligible for intensive induction chemo.

The approval is a conditional one, meaning the partners may have to succeed in confirmatory trials to keep the indication. But so far, the drug has impressed regulators with its complete remission rates, which checked in at 37% of trial patients taking Venclexta with azacitidine, 54% of patients on a Venclexta-decitabine regimen and 21% of those receiving Venclexta alongside low-dose cytarabine.

RELATED: AbbVie, Roche drive Venclexta toward $3B with Rituxan combo nod in CLL

For Venclexta, it’s the first FDA nod outside of the chronic lymphocytic leukemia arena, where it won its first OK back in 2016. Since then, AbbVie and Roche have successfully expanded the drug’s market to include all relapsed CLL patients, rather than just those bearing a genetic mutation known as the 17p deletion.

That success led analysts to predict that Venclexta could hit $3 billion by 2022, putting it among oncology’s best-sellers in that year.

RELATED: Novartis wins FDA nod for Rydapt, a new targeted drug for acute myeloid leukemia

But if the companies want to see big contributions from the new AML indication, Venclexta will have to get past competitors from companies including Pfizer and Novartis. Last year, Novartis picked up an FDA nod for Rydapt, approved specifically for newly diagnosed patients with a specific genetic mutation. Pfizer, though, scored a broader approval for Daurismo the same day AbbVie and Roche received their good Venclexta news, and the Pfizer drug will be eligible to treat the same population as Venclexta.

Meanwhile, AbbVie and Roche are readying Venclexta in other diseases, too, including multiple myeloma and follicular lymphoma. Both drugmakers are counting on Venclexta sales to fill forthcoming sales gaps as biosimilars go after AbbVie giant Humira and Roche blockbusters Rituxan, Avastin and Herceptin.