Seeking to clear up a ‘misconception,’ Oncology Center of Excellence officials say earlier endpoints, such as progression-free survival and overall response, continue to be useful in getting therapies to market quicker, but sponsors still should plan to systematically collect OS data to ensure there is no detriment to survival.

Deal Snapshot: Ipsen committed up to $1.8bn in upfront and milestone fees to develop novel treatments for rare neurological diseases with Skyhawk’s RNA-targeting small molecule platform.

Notable new drug approvals in South Korea last year included Pfizer’s Tukysa, Genentech’s Columvi and BeiGene’s Tevimbra, but the tally did not include any domestically-originated products. Alzheimer’s disease therapy lecanemab may be on the horizon this year.

The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.