China, FDA

In a first, China’s BeiGene scores FDA ‘breakthrough’ status for BTK inhibitor — potential rival for Imbruvica

BeiGene may have made its rep as a PD-1 pioneer in China, but it’s coming to the US with more cancer drugs in its arsenal.

The biotech $BGNE says its Bruton’s tyrosine kinase (BTK) inhibitor, zanubrutinib, now enjoys breakthrough status granted by the FDA — specifically, in the treatment of adult patients with mantle cell lymphoma who have been treated with at least one prior therapy.

It’s the first cancer therapy from mainland China to receive this endorsement, BeiGene president and general manager of China Xiaobing Wu told BioCentury.

At the ASH annual meeting in December, BeiGene read out a Phase II trial in mantle cell lymphoma, reporting an overall response rate of 84%, with 59%, or 50 patients, achieving complete response. Twenty-one patients, however, discontinued zanubrutinib.

“Zanubrutinib has been designed to maximize BTK occupancy and minimize off-target effects,” chief medical officer Jane Huang said in a statement.

The most advanced trial for the drug involves patients with Waldenström macroglobulinemia — a rare and incurable form of non-Hodgkin lymphoma — and pits zanubrutinib directly against J&J and AbbVie’s blockbuster Imbruvica (ibrutinib), currently the only FDA-approved BTK inhibitor for the indication. BeiGene has secured fast track designation for that use.

Other late-stage studies underway target untreated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL); relapsed/refractory (R/R) follicular lymphoma; and R/R CLL/SLL.

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