BeiGene discloses delay in zanubrutinib filing

8 November 2018

China’s BeiGene (Nasdaq: BGNE) has disclosed a delay in plans to file a New Drug Application (NDA) for zanubrutinib in relapsed/refractory (R/R) Waldenstrom's macroglobulinemia (WM) from first-half 2019 to 2019-Early 2020 in light of updated US Food and Drug Administration feedback.

Management has suggested that there are no material changes to the zanubrutinib dataset and there are no deficiencies in either toxicology or manufacturing (CMC) work that caused the delay. Rather, the agency appears to now prefer controlled data, rather than single arm, in light of Imbruvica's (ibrutinib) recent controlled data with Rituxan (rituximab) in this setting, commented Leerink analyst Andrew Berens.

Zanubrutinib is currently being studied head to head with Imbruvica in a Phase III trial with data expected in 2019. Although BeiGene will continue interacting with the agency regarding the potential for an accelerated filing, the analyst now sees this randomized Phase III data as his base case for US approval, which he has shifted to 2021.

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