BeiGene’s Brukinsa gains FDA accelerated approval for follicular lymphoma treatment
Betsy Goodfellow | March 8, 2024 | News story | Medical Communications | BeiGene, Brukinsa, FDA, Oncology, follicular lymphoma
BeiGene has announced that the US Food and Drug Administration (FDA) has granted accelerated approval to Brukinsa (zanubrutinib) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL), used in combination with obinutuzumab, after at least two lines of systemic therapy.
This accelerated approval is based on the response rate and durability of response from the ROSEWOOD trial, as well as marking the drug’s fifth indication in B-cell malignancies in the US. Continued approval for this indication is likely to be dependent on the verification of clinical benefit in the confirmatory MAHOGANY trial, which is currently underway.
Mehrdad Mobasher MD MPH, chief medical officer, haematology at BeiGene, commented: “This accelerated approval of Brukinsa represents an important advancement, offering the first and only BTK inhibitor treatment for follicular lymphoma patients in the US who have either not responded to initial therapies or have experienced relapse. Brukinsa is the only BTK inhibitor to date that shows efficacy with this type of malignancy and now has the broadest label, including five oncology indications, of any medication in its class globally. This is a testament to Brukinsa’s differentiated clinical profile and our continued commitment to bringing this much-needed treatment option to patients around the world.”
Betsy Goodfellow
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