Less than two years after BeiGene’s Brukinsa made history as the first cancer drug discovered in China to score an FDA approval, the BTK inhibitor is racking up another win in a different form of lymphoma.
BeiGene scored an accelerated FDA approval for Brukinsa, also known as zanubrutinib, in adults with relapsed or refractory marginal zone lymphoma (MZL) who have been previously treated with at least one anti-CD20-based regimen, the company said Wednesday.
Brukinsa has been on a roll lately, scoring roughly a dozen global regulatory approvals in just under two years. To start off September, the FDA granted the med a nod in adult patients with Waldenström’s macroglobulinemia, a rare type of lymphoma.
With BeiGene’s latest MZL nod in hand, the Beijing-based drugmaker is turning up the heat against AbbVie and Johnson & Johnson’s blockbuster Imbruvica, which scored an FDA approval for the same group of patients in 2017. The med will also challenge TG Therapeutics’ Ukoniq, which won an accelerated go-ahead in the use earlier this year.
BeiGene has already faced an uphill battle with market-leading Imbruvica, the fifth best-selling drug globally last year with $8.43 billion in sales. However, BeiGene, a relative latecomer in the BTK space, has managed to post some gains against Imbruvica in the clinic, including in the pivotal chronic lymphocytic leukemia market.
As for MZL, BeiGene is pricing Brukinsa at a wholesale acquisition cost of $13,491 per 120-count bottle, or a 30-day supply, a company spokesperson said. That marks about a 10% discount from Imbruiva’s price of $14,920, the company said.
MZL is a slow-growing type of B-cell non-Hodgkin lymphoma where the abnormal B-cells beat out healthy cells. The disease, considered chronic and incurable, can crop up as three different subgroups depending on where those B cells multiply.
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The FDA based its decision on the overall response rate from BeiGene’s two single-arm clinical trials and is contingent on a confirmatory trial to prove Brukinsa’s worth.
BeiGene’s 66-patient phase 2 trial, dubbed Magnolia, found that Brukinsa was tied to a response in 56% of patients with all three forms of MZL and a complete response in 20%, BeiGene said. The company couldn’t determine the duration of response.
The drug does carry some side effects, including a decreased neutrophil count, upper respiratory tract infection, decreased platelet count, hemorrhage, decreased lymphocyte count, rash, and musculoskeletal pain, the company said.
BeiGene’s BTK inhibitor, which scored its first-ever FDA nod in 2019 for previously treated adults with mantle cell lymphoma (MCL), is being studied as a single therapy and in combo with other drugs to treat various B-cell malignancies, according to the company.