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LSK BioPharma Announces Successful Outcome from End-of-Phase 2 meeting with FDA
FDA meeting clears pathway to initiation of pivotal phase 3 study
LSK BioPharma (LSKB) today announced the successful completion and positive outcome of an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) for apatinib, an investigational drug for treatment of solid tumors. The FDA had no major objections to LSKB’s global phase 3 pivotal-trial study design for apatinib in patients with advanced gastric cancer. The Company believes the plan to conduct a single phase 3 clinical trial will be sufficient to support an accelerated development pathway and NDA submission.
“We had a good, collaborative meeting with the U.S. FDA,” said Dr. Sung Chul Kim, President of LSK BioPharma, “we received valuable guidance that we expect will help us to quickly bring apatinib to market and provide a much needed therapy to support cancer patients worldwide.”
LSKB is now finalizing the global phase 3 pivotal trial-study design and expects to start as quickly as possible. The phase 3 design is a randomized placebo-controlled study examining the safety and efficacy of apatinib in advanced gastric cancer patients to be conducted in the U.S., Europe, Japan, Korea, and Taiwan.