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BeiGene's NDA for Zanubrutinib Gets Priority Review From FDA

Chinese biotech company, BeiGene, Ltd. BGNE announced that the FDA has accepted and granted priority review designation to its new drug application (NDA) for its cancer candidate, zanubrutinib. A decision from the FDA is expected by Feb 27, 2020.

The NDA is seeking approval for zanubrutinib as a treatment for patients with mantle cell lymphoma (MCL) — an aggressive form of lymphoma – in second or later line settings. In January, the candidate was granted Breakthrough Therapy designation for the same indication. Notably, FDA’s Breakthrough Therapy designation is granted to speed up the development and review of drugs that target serious or life-threatening conditions.

The NDA was filed based on data from a pivotal phase II study in relapsed or refractory MCL patients and phase I/II study in patients with B-cell lymphomas.

A glimpse of BeiGene's price trend so far this year reveals that it has gained 4.2% against the industry’s 1.1% decline.

Data from the phase II study showed that treatment with zanubrutinib achieved overall response rate (the study’s primary endpoint) of 83.7% with complete response achieved in 77.9% of patients after a follow-up period of 18.4 months. Median progression-free-survival (PFS) achieved in the study was 19.1 months, with approximately 72.1% patients achieving 15 months of PFS.

Meanwhile, data from the phase I/II showed that zanubrutinib was well tolerated and highly active in patients with MCL.

BeiGene is also developing zanubrutinib in several other lymphoma indications. A late-stage study is evaluating the candidate in combination with Teva’s TEVA Treanda (bendamustine) plus Roche’s RHHBY Rituxan (rituximab) in patients with treatment-naive chronic lymphocytic leukemia (“CLL”) or small lymphocytic lymphoma (“SLL”).

Zanubrutinib is already under review for r/r MCL and CLL/SLL indications in China.

Apart from zanubrutinib, BeiGene is developing an anti-PD-1 antibody, tislelizumab, in multiple oncology indications including non-small cell lung cancer in first and later-line settings. Moreover, the company is developing a PARP inhibitor, pamiparib, for treating ovarian cancer.

Currently, BeiGene generates revenues from the sales of cancer drug – Abraxane, Revlimid and Vidaza – in China, under a distribution license from Celgene CELG.

Zacks Rank

BeiGene currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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Roche Holding AG (RHHBY): Free Stock Analysis Report
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