The US Food and Drug Administration (FDA) has granted accelerated approval to BeiGene’s Brukinsa (zanubrutinib) for patients with advanced forms of follicular lymphoma.

The approval is for the drug’s use in combination with Roche’s Gazyva (obinutuzumab). Adults with relapsed or refractory forms of the cancer who have tried two or more lines of systemic therapy will be eligible for the combination therapy.

The FDA go-ahead in follicular lymphoma marks the fifth approved indication – all of which are in B-cell malignancies – for Brukinsa in the US.  The blockbuster drug has already hit sales of $1.3bn in 2023, with it forecast to see sales of $4.2bn by 2029, according to GlobalData’s Pharma Intelligence Centre.

GlobalData is the parent company of Pharmaceutical Technology.

BeiGene’s Brukinsa is now the first BTK inhibitor approved for follicular lymphoma in the US and has the broadest label compared to competitors, BeiGene’s chief medical officer Mehrdad Mobasher said in a 7 March press release.

The FDA based its decision on results from BeiGene’s Phase II ROSWOOD trial (NCT03332017). The trial, which enrolled 217 patients, compared Brukinsa plus Gazyva to Gazyva alone. The overall response rate (ORR) in the combo arm was 69%, higher than the 46% seen in those taking the monotherapy. The ORR in patients taking Brukinsa plus Gazyva was maintained after 18 months.

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Whilst the combo therapy was generally well-tolerated, serious adverse reactions occurred in 35% of patients. This led to 17% of patients permanently discontinuing the therapy.

For full approval, BeiGene will likely need clinical benefit consolidation from its ongoing confirmatory MAHOGANY trial (NCT05100862).

Follicular lymphoma is the second most common type of non-Hodgkin lymphoma, with approximately 15,000 cases in the US each year. Whilst the disease is incurable, treatments can help patients live longer.

China-founded BeiGene will face competition in the third-line follicular lymphoma treatment market, in which big pharma features heavily.

Novartis’ CD-19-directed immunotherapy Kymriah gained accelerated approval from the FDA in May 2022. Kymriah, a CAR-T therapy, has demonstrated strong efficacy here – posting an ORR of 86%.

Gilead Sciences’s cell therapy Yescarta went even further, demonstrating a 91% ORR. Yescarta was given an FDA accelerated approval nod in follicular lymphoma in March 2021.

Roche is offering an off-the-shelf treatment in the form of its bispecific antibody Lunsumio (mosunetuzumab). Lunsumio was granted accelerated approval in January 2023.

AbbVie and Bristol Myers Squibb also have applications for their candidates under FDA priority review.

The Follicular Lymphoma Foundation said that “the emergence of new treatment options, which have been shown to be effective and well-tolerated, including second-generation BTK inhibitors such as zanubrutinib in combination with existing therapies, brings hope to those dealing with advanced follicular lymphoma”.

Update: The third paragraph has been updated to reflect that Brukinsa is not a monoclonal antibody as stated in a previous version.