Shots:
- The sDNA submission is based on a P-III APSEN study assessing Brukinsa vs ibrutinib in 351 patients with WM and includes a pivotal P-II trial of zanubrutinib in r/r WM conducted in China and P- I/II trial in patients with B-cell malignancies
- Additionally, safety data from 779 patients in 6 trials of Brukinsa were included in the submission with the anticipated PDUFA date as Oct 18, 2021. Brukinsa is also under regulatory review in the EU, Canada, Australia, China, Taiwan, and South Korea
- Currently, 20+ marketing applications of Brukinsa have been submitted covering 45 countries globally including the US, EU & China
Click here to read full press release/ article | Ref: BusinessWire | Image: Switzerland Global Enterprise
The post BeiGene Reports the US FDA’s Acceptance of sNDA for Brukinsa (zanubrutinib) in Waldenström’s Macroglobulinemia first appeared on PharmaShots.
