MCL: FDA Approval of a Second-Generation BTK Inhibitor


Michael Wang, MD: The recent approval is the new BTK inhibitor called zanubrutinib. Zanubrutinib is developed by this company called BeiGene, Ltd, and many of the key members actually studied in the United States. The compound has very high efficacy and have a very good safety profile. I was involved in the development of this compound from the very primitive stages, and I actually treated patients on the trial, so I know this compound very well.

This compound, in my opinion, will be used worldwide but mainly in places like the Asia and Australia. I could be wrong, but I think it’s going to be adding another very potent agent to the usage and therapy for B-cell lymphomas. But B-cell lymphomas are not a very trivial disease. Let me just explain to you. Although the incidence is not very high, because people live for a long time—in America, about 0.7 million Americans live with B-cell lymphoma—many of those B-cell lymphomas could be interrogated by a BTK inhibitor such as zanubrutinib. Although zanubrutinib is approved only for mantle cell lymphoma, this is a second-generation drug. The first generation is ibrutinib, and the second generation, acalabrutinib and zanubrutinib. The first-generation of ibrutinib was approved by the FDA in November 2013 and is widely used. And the second, acalabrutinib, was approved in October 2017. I have been so fortunate. I led 2—there are 2 separate international trials that led to the FDA approval. And every morning I wake up knowing that somebody is taking the pill to treat lymphoma, and I feel very satisfied.

But now we have a third agent. The first-generation ibrutinib-acalabrutinib has been mainly studied in the Western population. Yes, they are a little bit in China and in the Asian countries; they are being used there. But zanubrutinib is mainly studied in the Asian and Australian populations. I think we need more BTK inhibitors, not only because we have a big population of patients who are taking these medicines, but also there are more medicines like this that we can drive down the price competitively.

Now let me come back to zanubrutinib. Zanubrutinib is so powerful. When it is given in mantle cell lymphoma, the response rate is about 90%. Think about it: You swallow a pill and you don’t have to go to the hospitals, you don’t do the 5 medicines, you don’t have to have the nausea and vomiting and all that. You just go home and swallow the pill, and 90% of the tumors will shrink. Frankly, 30%, 40% different trials of zanubrutinib, the highest 59% of patients, all the tumors are totally gone. You can see the power of targeted therapies. Of course, the zanubrutinib is new, but before that it was the ibrutinib-acalabrutinib. It was very effective. We cannot tell anything, but I think they are equally potent in my opinion. They just have different properties and different adverse effects. I really think zanubrutinib approval is a very big step forward and very efficacious. The safety profile is very tolerable and consistent with other first- and second-generation BTK inhibitors.

Transcript Edited for Clarity

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