FDA approves BeiGene's Brukinsa in rare blood cancer amid company's US expansion plans
BeiGene has been anything but shy about its US expansion plans centered around blood cancer drug Brukinsa. To see those plans through, BeiGene will have to go right at AbbVie and J&J’s Imbruvica, and Brukinsa now has one more arrow in its quiver as part of that battle.
The FDA on Wednesday approved BTK inhibitor Brukinsa to treat Waldenström’s macroglobulinemia, a rare form of lymphoma, after the drug aced a head-to-head showdown with Imbruvica, the only other drug approved for that disease, BeiGene said in a release.
The agency based its review on data from the Phase III ASPEN study, which pitted Brukinsa against Imbruvica on a primary endpoint of a very good partial response (VGPR) as judged by an independent review committee. BeiGene’s drug posted a VGPR rate of 28% compared with 19% for Imbruvica by one criterion, and another measure saw rates of 16% for Brukinsa and 7% for Imbruvica.
The drug’s label determined Brukinsa’s partial response rate as 78%, compared with 78% for Imbruvica, and a 12-month event-free duration of response rate of 94%, as opposed to 88% for Imbruvica. The most common side effects for Brukinsa’s drug were decreased neutrophil count, upper respiratory tract infection, decreased platelet count, rash, hemorrhage, musculoskeletal pain, decreased hemoglobin, bruising, diarrhea, pneumonia and cough.
This is now the second approval for Brukinsa in the US and comes as BeiGene looks to greatly expand its footprint stateside. To do so, the company has taken the fight right at Imbruvica, looking to steal market share away from the blockbuster hematology drug from AbbVie and J&J to help fuel its own expansion.
“With 11 regulatory approvals in under two years, including two in the U.S., Brukinsa is demonstrating its growing utility as a treatment option for B-cell malignancies and expanding its footprint to potentially benefit more patients worldwide,” BeiGene’s hematology CMO Jane Huang said in a statement. “We will continue to evaluate Brukinsa in its broad global clinical program and look forward to additional clinical evidence to establish its position as a potentially best-in-class medicine.”
In early August, BeiGene announced plans to establish a sprawling, 42-acre R&D and manufacturing facility in Hopewell, NJ. The site expects to hire hundreds in the coming years, BeiGene said at the time, and will serve as the US/Chinese drugmaker’s waving flag for its growing market ambitions with Brukinsa at the forefront.
The drug in July beat a combination of chemotherapy bendamustine and Roche’s Rituxan to extend the lives and halt the progression of disease in patients with chronic lymphocytic leukemia or small lymphocytic leukemia in a Phase III study. That’s another major Imbruvica indication, and if the company wins FDA approval, it will add to its June 2020 approval for the treatment of CLL and SLL in China. Brukinsa also sports an FDA approval in mantle cell lymphoma.