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BeiGene wins expanded approval for leukemia drug, intensifying battle with AbbVie, AstraZeneca

The Food and Drug Administration has approved BeiGene’s targeted cancer drug Brukinsa for use in a type of leukemia, the company said Thursday. The decision expands the treatment’s market and puts it in a battle with AbbVie and Johnson & Johnson’s Imbruvica and AstraZeneca’s Calquence in the most common form of the disease.

BeiGene hopes data from a clinical trial testing Brukinsa head to head against Imbruvica will give it an edge in chronic lymphocytic leukemia, a condition in which Brukinsa outperformed the AbbVie and J&J drug in delaying disease progression or death in the ALPINE trial.

The newly approved labeling for Brukinsa only lists the drugs’ relative response rates in that study, however, as the progression-free survival data only became available late last year.

“We believe Brukinsa is well-positioned to become the [drug] of choice across multiple indications,” Mehrdad Mobasher, BeiGene’s hematology chief medical officer, said in a statement.

Brukinsa is entering a hard-fought commercial battle. Calquence has begun to eclipse Imbruvica, the first so-called Bruton’s tyrosine kinase inhibitor to be launched. Sales through Sept. 30, 2022 for Calquence were $1.5 billion to Imbruvica’s $3.4 billion.

AbbVie executives acknowledged that rival drugs had taken market share in mid-2022, and at the J.P. Morgan healthcare conference earlier this month CEO Richard Gonzalez told investors the company “has significantly lowered our sales expectations.”

Calquence’s main edge has been a better side effect profile. When compared to Imbruvica, it is similarly effective in delaying disease progression and has fewer instances of irregular heartbeat, a side effect that puts Imbruvica patients at elevated risk of stroke or heart failure.

In the ALPINE trial, 14 patients taking Imbruvica quit taking it because of cardiac disorders, compared with one taking Brukinsa. Six trial participants died from cardiac events, all of whom had taken Imbruvica, and three of them died within four months of starting treatment.

Brukinsa first won approval in 2019 in a rare condition called mantle cell lymphoma, which is often targeted first by drugmakers aiming to get approval in blood cancers. It later secured expanded use in another rare cancer called Waldenström’s macroglobulinemia, but later failed to prove superiority to Imbruvica in that condition. It’s also cleared for a third condition called marginal zone lymphoma in patients who had advanced on prior therapies.

Based on sales in those three indications, Brukinsa had sales of $389 million through the first nine months of 2022.