HLB said it would request for a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration to seek approval for rivoceranib, a targeted anticancer therapy, based on data of phase-3 gastric cancer trial.
The company initially planned to conduct an additional trial after the phase-3 study did not meet its primary endpoint. However, it recently reversed its stance and decided to go ahead with an application for new drug approval in the U.S.
|HLB Chairman Jin Yang-gon makes a video presentation on YouTube on Monday.|
HLB Chairman Jin Yang-gon announced the company’s plan for rivoceranib on YouTube on Monday, confirming the phase-3 data and analysis of the therapy.
“We analyzed the entire clinical data and concluded that we had obtained sufficient clinical significance from a large number of data,” Jin said. “With the advice of a group of experts, we decided to apply for a pre-NDA meeting with the FDA to receive new drug approval.”
He emphasized that the company would push for an FDA nod for rivoceranib because it confirmed many indicators were clinically meaningful in the final analysis of the data.
Jin expected the first meeting with the FDA to be around mid-October if the schedule goes as planned.
In June, HLB disclosed the topline results of the global phase-3 test on rivoceranib for the treatment of gastric cancer. It announced that the median of the progression-free survival was significantly meaningful, but the overall survival, which was the primary endpoint of the study, did not reach the final goal.
At the time, Jin had said HLB could face difficulty in winning FDA approval with the existing data, and that the company would conduct a small, additional clinical trial.
HLB’s Science Advisory Board (SAB) had recommended an additional study at the time, but the latest analysis of the entire data signaled that rivocetanib had sufficient potential to be authorized as a new drug, Jin said.
“At a pre-NDA meeting, the FDA may advise us to seek NDA using this data or grants an NDA under a limited condition. In the worst scenario, it could recommend an additional trial,” said an official at HLB. “We internally concluded that our data was sufficient to apply for NDA.”
HLB is to submit the abstract of the trial results to the European Society for Medical Oncology by Aug. 21 and disclose the clinical data during the ESMO meeting in late September.
Jin also said rumors about a trial suspension were groundless.
“I feel heartbroken that shareholders and investors suffered a lot due to the misunderstanding and ‘noises’ after the disclosure of the topline results,” Jin said. “However, I can assure you that our trial has never stopped or failed.”