FDA Approves Beigene’s Brukinsa for Mantle Cell Lymphoma

3d rendered medically accurate illustration of too many white blood cells due to leukemia

The United States Food and Drug Administration (FDA) has granted approval to Brukinsa (Zanubrutinib). A blood cancer drug from Chinese company, BeiGene, giving access to Americans to a Chinese cancer therapy for the first time.

This is an important FDA approval since Mantle cell lymphoma (MCL) is a rare and very aggressive type of non-Hodgkin lymphoma mostly suffered by men over the age of sixty years. And it’s said that about three thousand to four thousand are diagnosed every year t in the United States. This explains why the Food and Drug Administration (FDA) has been working effortlessly to improve outcomes for patients battling with it worldwide and not just United States alone.

This new Bruton tyrosine kinase inhibitor known as Zanubrutinib is a small molecule that works by forming a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of Bruton tyrosine kinase activity. It is an important treatment option for people with refractory mantle cell lymphoma (MCL) who had received other therapies earlier.

The FDA relied largely on clinical trial data generated outside the US for the approval. According to the company, the treatment was tested on 118 patients, 10-15 per cent of whom were from the US. The approval was based on data from a single-arm, open-label, multicenter phase 2 trial that evaluated the safety and efficacy Brukinsa in 86 patients with MCL who had received at least one earlier treatment or therapy. From the analysis, it was noted that Brukinsa triggered an overall response rate of 84% with a median duration of response of 19.5 months. While on the other hand, a complete response was observed in 59% of affected persons and 24% of others achieved a partial response.

Although, Brukinsa is the first BeiGene-discovered drug to be approved by US FDA for her citizens, it is expected to be the first of many approvals for Brukinsa as researchers continue to evaluate its potentials in other hematologic cancers. Today, BeiGene becomes the first FDA green light and first BeiGene-discovered cancer drug in China. And with plans to launch Brukinsa soon, BeiGene will surely be competing with similar blood therapies like Johnson & Johnson and AbbVie’s Imbruvica, AstraZeneca’s Calquence, and Celgene’s Revlimid. It will be interesting to see who emerges top from the healthy rivalry. Beigene, has maintained that it expects to see another one of its cancer drugs very soon, and is equally running a confirmatory phase 3 trial for patients who are not fit for stem cell transplantation.

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