Amgen initiates Phase I trial of melanoma drug combination
The trial is designed to evaluate the safety of talimogene laherparepvec in combination with Merck’s FDA approved, anti-PD-1 therapy Keytruda, as well as the efficacy of this combination
The US Food and Drug Administration (FDA) has approved an expanded indication for Eli Lilly and Company’s Jaypirca (pirtobrutinib) as a first-line treatment for adults with previously untreated chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) who do not have a 17p deletion.
The sNDA for a monotherapy indication is based on data from two double-blind, historical-controlled, multicenter randomized, Phase III trials (093-046 and 093-045) with identical study designs. The trials
In one long-term study of pediatric patients with acute lymphoblastic leukemia (ALL), results showed that 36 of 39 pediatric patients with relapsed/refractory (r/r) ALL, or 92%, experienced complete