INNOVENT BIO (01801) announced that the non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, Pirtobrutinib, has received approval from China's National Medical Products Administration (NMPA) for a new indication. The drug is now approved for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously undergone at least one systemic therapy that included a BTK inhibitor. Pirtobrutinib is a highly selective kinase inhibitor that utilizes a novel binding mechanism. It can re-establish BTK inhibition in CLL/SLL patients previously treated with covalent BTK inhibitors, such as ibrutinib, acalabrutinib, zanubrutinib, or orelabrutinib, thereby continuing the benefits of targeting the BTK pathway. As a non-covalent (reversible) BTK inhibitor, Pirtobrutinib was approved by the U.S. Food and Drug Administration (FDA) in January 2023. In October 2024, the drug was approved in China as a monotherapy for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who had received at least two prior systemic therapies, including a BTK inhibitor. The approval of this new indication is based on results from the international, multicenter, randomized controlled BRUIN CLL-321 Phase III study. BRUIN CLL-321 is the world's first randomized Phase III trial conducted in CLL/SLL patients previously treated with a covalent BTK inhibitor. The study enrolled 238 patients and aimed to compare the efficacy and safety of Pirtobrutinib monotherapy versus the investigator's choice of either idelalisib plus rituximab or bendamustine plus rituximab. Results showed that Pirtobrutinib significantly extended median progression-free survival (14.0 months vs. 8.7 months, hazard ratio [HR]=0.54) and demonstrated a lower discontinuation rate due to treatment-related adverse events (5.2% vs. 21.1%), further validating its efficacy and tolerability advantages in this patient population. The approval of Pirtobrutinib for CLL/SLL in China represents a significant breakthrough in this field, marking a step towards ensuring Chinese patients can benefit from this global innovation. The company will leverage its leading brand and professional commercialization capabilities in oncology to accelerate access to this innovative therapy and benefit more cancer patients in need.
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