Big Drug Wins with the FDA announced by Biotech Companies

Several biotech and biopharmaceutical companies have announced significant FDA victories, ranging from approvals of Experimental New Drug applications for cancer therapy candidates to Fast Track Designations for investigational drugs aimed at treating opioid use disorder. The FDA approved Kronos Bio’s IND for lanraplenib, a next-generation spleen tyrosine kinase inhibitor, for relapsed/refractory and newly diagnosed acute myeloid leukaemia on Tuesday. The medication is designed to target AML with FLT3 mutations and/or NPM1 mutations.

Kronos Bio’s chief medical officer and executive vice president of clinical development, Jorge DiMartino, M.D., Ph.D., said, “This LANRA IND caps off an outstanding year for our SYK portfolio, which we acquired just over a year ago. Since that time, we have nearly completed the integration of the ENTO and LANRA programs with our systems, built out the requisite clinical, translational, regulatory and manufacturing infrastructure for LANRA and ENTO and had successful interactions with the FDA, both for the ENTO Phase 3 clinical trial, as well as for LANRA in relapsed/refractory FLT3-mutated AML patients.”

With the IND approved, Kronos Bio can begin a Phase I/II study of LANRA in combination with gilteritinib, an anti-cancer drug that suppresses FLT3, in patients with relapsed/refractory FLT3-mutated AML. The research will begin in the fourth quarter of 2021. This is the company’s first IND for its medication in a cancer indication. In prior trials, the drug was found to be safe in over 250 healthy people and patients with autoimmune diseases.

Kronos Bio’s other SYK inhibitor, ENTO, is also entering a registrational Phase III clinical trial, according to Dr. DiMartino. The results of this study could pave the way for an accelerated approval of the drug in combination with chemotherapy for the treatment of newly diagnosed NPM1-mutated AML.