A study conducted by the Asia-Pacific Oncology Drug Development Consortium finds substantial variability in regulatory approval delays of pembrolizumab and trastuzumab deruxtecan (T-DXd) across 10 Asia-Pacific (APAC) territories, and a lack of consistent prioritization of high-incidence tumours, high clinical benefit scores or curative treatment intent.
“The APAC region accounts for more than half of all global cancer incidents … However, regional regulatory approvals are in the range of 68–91 percent of [US] FDA-approved indications. For every year of delayed access, roughly 928,000 patient life-years are potentially lost,” stated first author, Dr Yanning Xu of Tan Tock Seng Hospital, Singapore.
Using US FDA approvals from January 2020 through December 2025 as the benchmark, the study measured the interval between FDA approval and local regulatory approval across 14 indications for pembrolizumab and seven for T-DXd. [Xu Y, et al, ESMO TAT Asia 2026, abstract 177RO]
“We chose pembrolizumab and T-DXd as both have demonstrated clinical benefit across multiple tumour types in both curative and palliative settings,” explained Xu. “We aimed to describe regulatory approval delays in terms of median time for first regulatory approval of each drug across 10 territories [Australia, New Zealand, Japan, South Korea, Hong Kong, Singapore, Malaysia, and the Philippines] and local regulatory delays for each US FDA–approved indication, for which data was only available in Australia, Japan, South Korea, and Singapore.”
Delays in approvals varied substantially across the region. The median time to first approval of pembrolizumab based on KEYNOTE 001/010 data ranged from 8.9 months in Australia to 85.9 months in the Philippines. For T-DXd, the median delay to first approval based on DESTINY-Breast-01 data ranged from 3.1 months in Japan to 54.9 months in the Philippines. T-DXd had not yet been approved in Vietnam by the December 2025 cutoff date.
Japan demonstrated the shortest median per-indication delays, with 10.4 months for pembrolizumab and 6.9 months for T-DXd. Singapore had the longest median per-indication approval delay for pembrolizumab (17.9 months), while Australia had the longest median per-indication delay for T-DXd (13.7 months). Coverage of approved indications differed among countries, at 86–93 percent for pembrolizumab and 57–100 percent for T-DXd.
Subgroup analyses showed that highest-incidence tumour types did not consistently receive faster approvals. While lung cancer indications for pembrolizumab and breast cancer indications for T-DXd had some of the shortest delays, significant delays persisted for gastric and colorectal cancers.
The relationship between approval timing and clinical benefit using the European Society for Medical Oncology (ESMO) Magnitude of Clinical Benefit Scale (MCBS) was also examined. High-benefit pembrolizumab indications generally showed shorter delays vs lower-benefit indications (range, 6.0–17.8 months vs 20.2–31.5 months). However, the pattern was less clear for T-DXd, suggesting that clinical value alone did not consistently drive approval speed.
“In the subgroup of treatment intent analysis, median regulatory delays were fairly similar between curative and palliative pembrolizumab indications, at 10–17 months vs 10.4–18.2 months,” highlighted Xu. “All of T-Dxd’s indications were of palliative intent at the time.”
“Regulatory delays for these two important oncological drugs varied substantially across the 10 territories in our study. In four territories with indication-level data, we did not observe consistent prioritization of high-incidence tumors, high clinical benefit, or curative intent indications,” said Xu. “These findings highlight the inequity of drug approval in our region. As a community, we should advocate for improved engagement across industry, regulators and clinicians to improve timely access, especially for higher-benefit oncology drugs across the region.”