APS Announces Successful Completion of Pre-IND Meeting With FDA

On August 26, 2021 APS reported that successfully completed the Pre-IND meeting with the US Food and Drug Administration (FDA) (Press release, Applied Pharmaceutical Science, AUG 26, 2021, View Source [SID1234613103]). APS plans to conduct a clinical trial of next-generation RET inhibitor APS03118 in patients not limited by tumor type, under the US IND . The patients with RET-positive non-small cell lung cancer, thyroid cancer or other solid tumors that develop resistance to RET inhibitors will be recruited in the study to investigate the safety and efficacy of APS03118. At the meeting, the FDA provided feedback regarding APS’s planned initiation of clinical trials under a U.S. IND for its lead next-generation RET inhibitor APS03118.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!