预约演示
FDA accepts BeiGene’s sNDA for follicular lymphoma therapy
2023-07-13
孤儿药引进/卖出临床结果临床2期快速通道
BeiGene haematology chief medical officer Mehrdad Mobasher noted that Brukinsa is the first Bruton’s tyrosine kinase inhibitor to demonstrate efficacy in follicular lymphoma. Credit: BeiGene / Business Wire.
BeiGene haematologyg Administration (FDA) has accepted for review BeiGBrukinsapplemental newBruton’s tyrosine kinase inhibitorBruton’s tyrosine kinase for Brukinsa (zanubrutinib) plus obinfollicular lymphomaelapsed or refractory (R/R) follicular lymphoma (FL).
The treFood and Drug Administration (FDA)lt R/R FL patients, folloBeiGeneminimum of two previous lines of therapy.Brukinsa (zanubrutinib)obinutuzumabrelapsed or refractory (R/R) follicular lymphoma (FL)
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A decision on the approval for the treatment is expected in the first quarter of 2024.
Brukinsa is a small moleculeAtezolizumabrosiFollicular Lymphomaibitor that received fast track and orphan drug designation for R/R FL treatment.
The filing is based on findings from the Phase II ROSEWOOD clinical trial in 217 R/R non-Hodgkin FL patients, who had previously received treatment.
Safety data from the trial were in line with those from prior studies of both therapies.
Brukinsaerm trial findings alBruton’s tyrosine kinase (BTK) inhibitorrukinsa plus obinutuzumab continued at a median follow-up of 20.2 months.
BeiGene haematology chief medical officer Mehrdad Mobasher stated: “Follicular lymphoma is the most common slow-growing non-Hodgkin lymphoma, but there are limited treatment options for patients whose condition has progressed after two lines of therapy.
“We are therefore pleased that Brukinsa is the first Bruton’s tyrosine kinase inhibitor to demonstrate efficacy in follicular lymphoma and plan to continue worldwide regulatory submissions based on the ROSEWOOD results.”
The submissions for Brukinsa in the same indication are under reviewBrukinsaa, Canobinutuzumabland, the European Union and the UK.
BeiGeneest development comes after the company entered a licence agrFollicular lymphomaio’s antibody-drug conjugate thernon-Hodgkin lymphoma solid tumours.
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