US approves BeiGene's BTK inhibitor Brukinsa for mantle cell lymphoma

The FDA said Thursday that it granted accelerated approval to BeiGene's Brukinsa (zanubrutinib) to treat patients with relapsed and refractory mantle cell lymphoma (MCL) who have received at least one prior therapy. The disease "usually responds well to initial treatment, but eventually returns or stops responding," commented Richard Pazdur, acting director of the Office of Oncologic Diseases in the FDA's Center for Drug Evaluation and Research, adding that "clinical trials showed that 84% of patients saw tumour shrinkage with this therapy."

The filing was supported by data from a single-arm Phase II trial testing the next-generation BTK inhibitor, also known as BGB-3111, in 86 Chinese patients with MCL who had received at least one prior treatment. Results showed that 84% of patients experienced tumour shrinkage with a median duration of response of 19.5 months. Data from another single-arm trial that included 32 patients also demonstrated that 84% of participants achieved tumour shrinkage, with a median duration of response of 18.5 months, the agency added.

The FDA had previously granted Brukinsa a breakthrough therapy designation for the MCL indication. Meanwhile, the drug is being evaluated in a broad clinical programme as monotherapy and in combination with other treatments for various B-cell malignancies.

Other BTK inhibitors approved in the US include Johnson & Johnson and AbbVie's Imbruvica (ibrutinib) and AstraZeneca's Calquence (acalabrutinib), both of which have been cleared for second-line MCL.

Meanwhile, Amgen said last month that it would take a 20.5% stake in BeiGene to expand its presence in China as part of a deal worth approximately $2.7 billion.

To read more Top Story articles, click here.