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On December 15th, Eli Lilly announced that it has submitted a rolling application (NDA) for the next-generation BTK inhibitor pirtobrutinib (LOXO-305) to the FDA for the treatment of mantle cell lymphoma
From: Eli Lilly's official website
LOXO-305 is an under-research, oral, highly selective non-covalent Bruton's tyrosine kinase (BTK) inhibitor
In January 2019, Eli Lilly acquired Loxo Oncology for approximately US$8 billion and acquired a series of targeted anti-cancer drugs.
LOXO-305 is also the fastest-growing product among the new generation of BTK inhibitors targeting the BTKC481S mutation
According to the Insight database, the Chinese part of two head-to-head clinical trials of BRUINCLL-321 and BRUINMCL-321 have also been launched (CTR20212373, CTR20212310)
Pirtobrutinib Phase 3 clinical development
From: Eli Lilly's official website
In December 2020, Eli Lilly announced the global multi-center phase I/II clinical data of LOXO-305 (Abstract 542) at the ASH conference.
Eli Lilly's LOXO-305 has published clinical data
From: Insight database (http://db.
The results showed that among the 139 CLL/SLL patients who could be evaluated for efficacy, the overall response rate (ORR) was 63% (95%CI: 55-71)
For patients with BTKC481 mutation and patients without BTKC481 mutation, the ORR was 71% (17/24) and 66% (43/65), respectively
From: 2020ASH