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FDA priority review granted for BeiGene’s Brukinsa for marginal zone lymphoma

The FDA submission for Brukinsa in MZL includes results from the phase 2 MAGNOLIA trial

BeiGene’s Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa has been granted a priority review by the US Food and Drug Administration (FDA) for pretreated marginal zone lymphoma (MZL).

The Chinese pharma company is seeking approval for Brukinsa (zanubrutinib) for the treatment of MZL patients who have received at least one prior anti-CD20-based therapy.

If approved, MZL will become Brukinsa’s second indication in the US – the BTK received its first FDA approval in 2019 for the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy.

In China, BeiGene’s is approved for pretreated MCL patients as well as pretreated chronic lymphocytic leukaemia (CLL) or small lymphocytic leukaemia (SLL) patients.

“This is our first regulatory submission in MZL, a serious disease diagnosed in more than 2,000 patients every year in the US with no clear standard of care. In clinical trials, Brukinsa has demonstrated promising efficacy and tolerability in MZL and presents a potential new option for MZL patients,” said Jane Huang, chief medical officer, haematology at BeiGene. “

“We look forward to continuing our communications with the FDA in the coming months as we work on advancing the broad global development programme for our potentially best-in-class BTK inhibitor,” she added.

The FDA submission for Brukinsa in MZL includes results from the phase 2 MAGNOLIA trial in patients with relapsed or refractory MZL.

A total of 68 patients were enrolled in the trial, with identified high-risk features including an elderly population with a median age of 70 years, heavily pretreated patients with a median of two prior lines of therapy and over 30% with refractory disease and nearly 40% with nodal MZL.

Initial results from this trial, including 66 patients who were evaluable for efficacy, found an overall response rate (ORR) of 74.2% across all subtypes in the trial.

Of those who responded, 24.2% had complete responses (CR) and 50% experienced partial responses (PR).

The median follow-up time for progression-free survival (PFS) was 9.13 months and the PFS rate at six months and nine months was 80% and 67% respectively.

In addition, 79% of patients maintained a response at six months and the overall survival (OS) rate at 12 months was 94%.

BeiGene revealed in a statement that the FDA has set a prescription drug user fee act (PDUFA) target action date for Brukinsa in MZL for 19 September.

Article by
Lucy Parsons

19th May 2021

From: Regulatory

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