The US Food and Drug Administration (FDA) has granted Eli Lilly (NYSE: LLY) an accelerated approval for its reversible BTK inhibitor Jaypirca (pirtobrutinib) for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults who have received at least two prior lines of therapy. This regulatory milestone follows the FDA’s earlier approval of the drug for mantle cell lymphoma (MCL) earlier this year. The accelerated approval is subject to confirmation from a late-stage trial.
The preliminary decision was supported by data from a Phase I/II study, which indicated that in a subgroup of CLL/SLL patients who had previously received a BTK inhibitor and a BCL-2 inhibitor, the overall response rate (ORR) was 72% and the duration of response (DOR) was 12.2 months.
As stated in the press release, Jaypirca is the first reversible BTK inhibitor to be introduced in the US, and it is currently involved in several Phase III studies.- Flcube.com
