On BeiGene’s very first live earnings call, CEO and co-founder John Oyler on Thursday described a “once-in-a-lifetime opportunity.” To him, the company’s potential in chronic lymphocytic leukemia is akin to two other legendary Big Biotech stories—Gilead in HIV and Vertex in cystic fibrosis.
BeiGene’s chief medical officer for hematology, Dr. Mehrdad Mobasher, tells Jack O’Brien about BTK inhibitor Brukinsa’s latest lymphoma approval from the FDA and offers messaging advice to medical marketers.
The U.S. Food and Drug Administration has granted accelerated approval for the expanded use of BeiGene's (6160.HK) combination drug to treat certain patients with a type of blood cancer, the health regulator said on Thursday.
In a new lawsuit, AbbVie’s Pharmacyclics unit contends BeiGene’s Brukinsa infringes a patent on its blood cancer drug Imbruvica. Both Imbruvica and Brukinsa are irreversible BTK inhibitors approved in chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Thanks to cancer drugs Brukinsa and tislelizumab, BeiGene nearly doubled its global sales in 2022. But the most important launches for the meds either have just begun or are yet to come.
The FDA greenlit BeiGene’s Brukinsa for use in chronic lymphocytic lymphoma, an approval that should substantially expand the market for the drug in the US after it topped the current leading therapy in a trial.
If yesterday’s Ash late-breaker on Beigene’s Brukinsa signalled a changing of the guard in primary BTK inhibition, earlier data from Lilly’s pirtobrutinib and Nurix’s NX-2127 highlighted potential new options for patients who relapse on current BTK drugs.
As BeiGene gears up for an all-out war against AbbVie and Johnson & Johnson’s Imbruvica, the company has turned in more clinical evidence to show it has the winning BTK inhibitor to fight certain blood cancers.
As the third player to enter the BTK realm, BeiGene has had its eyes fixated on AbbVie and Johnson & Johnson’s market leader Imbruvica. After clinical wins in smaller indications, the Chinese-American biotech has once again posted competitive data for Brukinsa—this time in the all-important newly diagnosed leukemia.
BeiGene (NASDAQ:BGNE) announces that Brukinsa (zanubrutinib) has received accelerated approval from the FDA for the treatment of adult patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen.