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BeiGene gets speedy US review for lymphoma drug zanubrutinib

First US filing is major milestone for Chinese firm


Chinese biopharma company BeiGene has claimed priority review status for its BTK inhibitor zanubrutinib from the FDA, setting up a possible approval next February.

It’s a major milestone for BeiGene, representing the first time that one of its drug candidates has been filed in the US and accepted for review by the FDA.

The US regulator awarded the status for zanubrutinib as a second-line treatment for mantle cell lymphoma (MCL), an aggressive type of non-Hodgkin’s lymphoma for which the drug also claimed a breakthrough designation earlier this year.

Zanubrutinib was previously awarded fast-track status from the FDA for patients with Waldenström macroglobulinaemia (WM), a slow-growing form of NHL. It’s also in late-stage testing for chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL), with earlier-stage studies on the go in follicular lymphoma (FL) and marginal zone lymphoma (MZL)

BeiGene is trying to position zanubrutinib as a rival to AbbVie/Johnson & Johnson’s well-established BTK inhibitor Imbruvica (ibrutinib), which is already approved for several haematological disorders – including CLL, MCL and WM.

J&J said last month that sales of Imbruvica grew by a third to reach more than $1.6bn in the first six months of the year, while AbbVie said it made $1.1bn from the drug in the same period, a rise of 29%.

There’s also competition in the frame from AstraZeneca’s Calquence (acalabrutinib), which has been on the market since 2017 for MCL and has positive phase 3 data in hand for first- and second-line CLL. Calquence made $64m in the first six months of the year, so remains a long way behind Imbruvica as the market leader.

BeiGene – which listed on the Hong Kong stock exchange last year – has suggested its drug has a best-in-class profile when it comes to potency and selectivity and has a lower tendency to cause off-target effects.

The MCL filing is based on data from a phase 1/2 trial of BeiGene’s BTK inhibitor in patients with B-cell lymphomas, as well as an aggregate of 123 patients from a phase 2 trial of the drug in patients with relapsed or refractory MCL in China.

In addition to zanubrutinib, BeiGene is also developing PD-1 inhibitor tislelizumab – which has been filed for approval in China for classical Hodgkin’s lymphoma – and pamiparib, a PARP 1/2 inhibitor for ovarian cancer.

Article by
Phil Taylor

22nd August 2019

From: Regulatory



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