Gilead’s Trodelvy wins Korean coverage for breast cancer -- too late for some and still off-limits up front

It took two years, 100,000 signatures, and a wave of public pressure from patients and doctors. Now, Gilead Sciences’ Trodelvy (sacituzumab govitecan) is finally reimbursed in Korea for metastatic triple-negative breast cancer (TNBC). But for many, the decision came too late to matter.

Effective June 1, coverage applies to third-line treatment of locally advanced or metastatic TNBC, as well as second-line use if recurrence occurs within a year of prior chemotherapy. Reimbursement also extends to third-line treatment of hormone receptor-positive, HER2-negative breast cancer.

For Korean patients, it marks the first access to an antibody-drug conjugate (ADC) in TNBC, a fast-moving and hard-to-treat subtype that lacks estrogen, progesterone, and HER2 receptors. That absence limits options for targeted therapy.

Each cycle of Trodelvy now costs patients 1,052,300 won ($769), a sharp drop from nearly 10 million won ($7,307), with the Korea Alliance of Patient Organizations estimating that about 280 patients a year will gain access under the new listing.

But as first-line access remains blocked -- and clinical trials push ahead -- many patients still find themselves behind the curve.

"This isn’t something to celebrate. People say ‘only two years?’ like it’s fast. It’s not,” said Professor Sohn Joo-hyuk of medical oncology at Severance Hospital, during Wednesday’s press conference on Trodelvy’s reimbursement.

He called the delay “unacceptable” for a drug with clear survival benefits and FDA approval already in hand, adding that no one should need “100,000 signatures just to get a cancer treatment reimbursed.”

Trodelvy was approved in Korea in May 2023 and launched commercially that October. It passed the cancer review committee within a month but it remained uncovered until May 31 this year. Finally, on June 1, it became Gilead’s first oncology drug added to Korea’s formulary and the first ADC for TNBC to receive coverage.

Choi Jae-yeon, general manager of Gilead Korea, said the process ran into predictable resistance but ultimately proved that new pathways can work. Trodelvy became the first drug to be reimbursed under a revised policy that allows regulators to consider a medicine’s “innovativeness” and clinical urgency when weighing cost-effectiveness.

In other words, it wasn’t just the data that got Trodelvy across the line -- it was the policy shift. Gilead re-submitted its application in late 2024, and by February 2025, the Health Insurance Review and Assessment Service (HIRA) had signed off. “The government clearly recognized the urgent need,” said Han Kong-sook, head of Gilead Korea’s oncology division, during the event.

Urgency is easy to quantify. While stomach and liver cancer rates have fallen in Korea, breast cancer has surged five- to six-fold over the past two decades, according to Gilead data. “Right now, one in fifteen women will develop it,” Sohn said. “Soon, it’ll be one in ten. Maybe even one in seven.”

Clinical trial data leaves little room for debate. In the phase 3 ASCENT trial, Trodelvy nearly doubled median overall survival in heavily pretreated metastatic TNBC patients, from 6.9 months on chemotherapy to 11.8 months. The hazard ratio for death was 0.51. That benefit held even in patients with brain metastases.

Interim data from the phase 3 ASCENT-04/KEYNOTE-D19 trial, presented at the American Society of Clinical Oncology 2025 Annual Meeting, showed median progression-free survival of 11.2 months for the Trodelvy-Keytruda (pembrolizumab) combination in the first-line setting, compared to 7.8 months with chemo plus Keytruda.

Yet in Korea, patients still can’t get Trodelvy in the first-line setting. Park Ji-yeon, founder of TNBC Korea, a patient advocacy group, and a three-time cancer survivor who was diagnosed with metastatic TNBC at age 39, called the delay “a slow death sentence” for many. 

“We’ve seen patients go without Trodelvy even after recurrence because of cost,” she said. One woman, she recalled, delayed treatment to lose weight and qualify for a lower dose she could afford. “Some didn’t live to see this day.”

After reimbursement took effect, that patient’s hospital bill dropped to 173,230 won, or just over $126.

Park doesn’t want symbolic victories. She wants structural reform. “Good drugs shouldn’t depend on whether you can afford them,” she said. “We need fast-track reimbursement for innovative drugs, especially when overall survival benefits are clear. That’s what insurance is for. It’s supposed to help when you’re facing something life-threatening, not save money by making people wait.”

Trodelvy’s listing marks the first time HIRA has applied its new framework for adjusting cost-effectiveness thresholds based on a drug’s innovativeness. Introduced in 2024, the rule lets payers factor in broader clinical value and unmet need, rather than relying strictly on cost-per-life-year calculations.

Many in the field say the system is still too slow, too reactive, and too political. “We keep acting like it’s okay for patients to wait while all the paperwork gets sorted,” said Sohn, echoing a sentiment shared by clinicians across the country. “But these are real people. They don’t have time to wait.”

Even with second- and third-line access in place, physicians say too many patients are still left waiting. If a drug shows survival benefit, Sohn argued, it should be reimbursed “right away,” not stalled by budget debates. 

For Gilead, the long fight was also a strategic one. Choi said the company’s goal is to reach 500,000 patients and families by 2030. But in TNBC, where rapid progression is common and targeted therapies have been largely out of reach, every day without access carries weight.

Trodelvy’s mechanism, which targets Trop-2 and delivers chemotherapy directly into tumor cells, was built for exactly this kind of challenge. 

Korean patients will now have access, though for now, it is limited to later lines of therapy. Park said that access means little if “critically ill patients are still waiting on policy reform to survive.”

Sohn put it more bluntly: “It shouldn’t take petitions or policy forums to make a proven treatment available,” he said. “We call it a win, but for patients who never got the chance, it came too late.”