In November 2019, the FDA accelerated the approval of Brukinsa capsules (zanubrutinib; from BeiGene), the second Bruton tyrosine kinase (BTK) inhibitor, for the treatment of adults with mantle-cell lymphoma (a type of non-Hodgkin lymphoma) who have received at least 1 previous therapy. The first BTK inhibitor approved, Imbruvica (ibrutinib) has improved outcomes for patients with different types of blood cancer, including mantle-cell lymphoma.
“Mantle cell lymphoma usually responds well to initial treatment, but eventually returns or stops responding, and the cancer cells continue to grow. This is a life-threatening condition. Clinical trials showed that 84% of patients saw tumor shrinkage with this therapy,” said Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence.
This approval was based on results of a clinical trial showing that 84% of the patients with mantle-cell lymphoma had a positive response to treatment with Brukinsa, and 59% of them had a complete response (no sign of cancer). The most common serious side effects with Brukinsa were pneumonia and bleeding.
