- The European Commission (EC) approved the expanded use of BeiGene's ( NASDAQ: BGNE ) medicine Brukinsa to treat adult patients with relapsed/refractory (R/R) marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy.
- BeiGene said that the EC granted an additional year of marketing protection because the data submitted for the therapeutic indication showed a significant clinical benefit for Brukinsa in comparison with existing therapies.
- BeiGene added that Brukinsa is the first and only Bruton’s Tyrosine Kinase (BTK) inhibitor for MZL approved in the EU.
- The The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) had recommended the approval of Brukinsa in this indication in September.
- Brukinsa is already approved in the EU to treat certain adult patients with Waldenström’s macroglobulinemia.
- BGNE +3.88% to $176.01 premarket Nov. 2
For further details see:
BeiGene rises as Brukinsa approved in EU for expanded use in blood cancer subtype