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BeiGene bags FDA approval for first product Brukinsa in lymphoma

Also the first approval for a Chinese-developed cancer drug in US


China’s BeiGene has claimed its first-ever product approval in the US, getting an FDA nod for its mantle cell lymphoma (MCL) therapy Brukinsa.

It’s also the first approval for a Chinese-developed cancer drug in the US, and is a marker of the emergence of China as a force on the international biopharmaceutical stage. It’s just the first of several cancer drugs BeiGene is hoping to bring to the US market.

The FDA has approved BTK inhibitor Brukinsa (zanubrutinib) as a treatment for adult patients with MCL who have received at least one prior therapy after a priority review that hadn’t been scheduled to complete until next February.

MCL is an aggressive type of non-Hodgkin’s lymphoma (NHL) for which Brukinsa also claimed a breakthrough designation from the FDA earlier this year.

The new approval positions BeiGene’s drug as a rival to AbbVie/Johnson & Johnson’s well-established BTK inhibitor Imbruvica (ibrutinib), which is already approved for several haematological disorders – including previously-treated MCL as well as other forms of NHL and chronic lymphocytic leukaemia (CLL).

First-to-market Imbruvica made more than $4bn in sales in the US market alone last year and remains the clear market leader despite some encroachment from AstraZeneca’s Calquence (acalabrutinib).

Calquence was approved in 2017 for second-line MCL and is under regulatory review in CLL. It made $108m in sales in the first nine months of this year.

BeiGene – which listed on the Hong Kong stock exchange last year – maintains its drug has a best-in-class profile when it comes to potency and selectivity and has a lower tendency to cause off-target effects.

“Mantle cell lymphoma usually responds well to initial treatment, but eventually returns or stops responding, and the cancer cells continue to grow,” said Richard Pazdur, acting director of the Office of Oncologic Diseases at the FDA.

“Clinical trials showed that 84% of patients saw tumour shrinkage with this therapy,” he added. “For patients whose disease relapses or becomes refractory, secondary therapies may be successful in providing another remission, and today’s approval will provide patients with another treatment option,” he added.

BeiGene said it will launch Brukinsa in the coming weeks, but hasn’t yet revealed its pricing plans. It’s also under regulatory review in China and Europe for MCL, as well as being in clinical development for CLL, small lymphocytic lymphoma (SLL), follicular lymphoma (FL) and marginal zone lymphoma (MZL).

BeiGene is also developing PD-1 inhibitor tislelizumab – which has been filed for approval in China for classical Hodgkin’s lymphoma – and pamiparib, a PARP 1/2 inhibitor for ovarian cancer.

Article by
Phil Taylor

15th November 2019

From: Regulatory



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