In Major Policy Change, Korea Will Let Patients Try Experimental Cancer Drugs Earlier (Yonhap)
SEOUL, Nov. 25 (Korea Bizwire) — South Korea is preparing to sharply loosen restrictions on who may enroll in clinical trials for new cancer drugs, a shift that could give patients earlier access to promising therapies and reshape long-standing practices in oncology care.
For years, many cancer patients and their families have confronted a painful paradox: even when a breakthrough therapy made headlines, only those who had exhausted all standard treatments — typically late-stage patients with no remaining options — were allowed into clinical trials. The rule was meant to prioritize safety but often left early-stage patients feeling shut out of what could be their best chance.
That is set to change. The Ministry of Food and Drug Safety announced on Nov. 25 that it will allow patients with remaining standard treatments — not only those in terminal stages — to participate in cancer drug trials, provided both the patient and their physician agree it is medically appropriate. The reform is one of the agency’s key regulatory initiatives for 2025 and is intended to expand patients’ “right to life and right to choose” their course of care.
The move comes as cancer therapeutics evolve rapidly. Newer treatments such as targeted therapies, antibody–drug conjugates and next-generation immunotherapies offer far fewer side effects and significantly stronger efficacy than older chemotherapy agents. Yet under the “late-stage first” rule, patients who were most likely to benefit from early intervention were denied access.
Clinicians and patient groups have been urging the government to rethink the system. Requests to allow early participation — even before all domestic standard treatments are tried — have surged, officials say.
In response, the ministry will publish new guidance by December titled “Considerations for Selecting Participants in Early-Stage Cancer Clinical Trials.” The framework emphasizes flexibility and patient choice, establishing clear criteria to permit trial access even when established treatment options remain.
The implications extend beyond individual care. Allowing early-stage patients into trials could help drug developers gather more meaningful data sooner, accelerating progress in therapies for hard-to-treat cancers.
The initiative, officials note, is rooted in months of consultations with patients, physicians and industry representatives through forums such as the ministry’s open policy roundtables. Far from a top-down decree, they say, the reform reflects a collective push to close gaps that have long frustrated those on the front lines of cancer treatment.
Lina Jang (linajang@koreabizwire.com)
