2021-08-26
APS Announces Successful Completion of Pre-IND Meeting With FDA
In August 2021, APS successfully completed the Pre-IND meeting with the US Food and Drug Administration (FDA). 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.
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