Beginning in April, Janssen Korea's prostate cancer drug Zytiga will be available with prednisolone as a first-line treatment for patients with asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer (mCRPC), with the patient’s out-of-pocket payment reduced from 30 percent (selective reimbursement) to 5 percent.
Metastatic castration-resistant prostate cancer occurs when prostate cancer spreads to the bones or other organs and continues to grow despite lowered blood testosterone levels. Patients with this condition typically have a survival time of only two to three years.
Janssen Korea's Zytiga
Janssen Korea's Zytiga
Zytiga is a once-daily oral anti-cancer drug that inhibits the CYP17 (Cytochrome P450 17A1) enzyme complex, which is essential for androgen production. By blocking the androgen production pathway in testicular, adrenal, and prostate cancer cells, it helps slow disease progression. It is administered in combination with prednisolone.
Janssen Korea announced that, effective April 1, Zytiga will be reimbursed with a 5 percent co-payment for patients with metastatic castration-resistant prostate cancer who have an ECOG performance status (PS) of 0 or 1 and experience no or mild pain that does not require narcotic analgesics.
The reimbursement change for Zytiga is based on a phase 3 COU-AA-302 clinical study in patients with metastatic castration-resistant prostate cancer who have not undergone chemotherapy.
The study demonstrated superior clinical benefits in the Zytiga plus prednisone arm compared to the placebo plus prednisone arm.
In the COU-AA-302 study, median imaging progression-free survival was 16.5 months in the Zytiga combination arm compared to 8.2 months in the placebo arm after a median follow-up of 27.1 months, representing a nearly twofold improvement.
Over a median follow-up of 49.2 months, median overall survival (OS) in the Zytiga combination arm was 34.7 months compared to 30.3 months in the placebo arm, a 4.4-month extension.
Hong Jun-hyuk, a professor of urology at Asan Medical Center, stated, "Zytiga is one of the first-line treatments for prostate cancer in clinical practice. This reimbursement change significantly reduces the financial burden on patients and enables healthcare providers to actively apply effective treatment options."
Kim Yeon-hee, Oncology Business and Rare Disease Unit Executive Director at Janssen Korea, added, "As a first-line treatment for patients with asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer, we have been working hard to expand access to prostate cancer treatment since Zytiga's reimbursement in 2019. We are pleased to announce that the out-of-pocket cost for Zytiga has been reduced after five years."
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HLB’s shot at FDA approval just took another hit. The agency has again rejected the company’s liver cancer drug, CAM-RIVO—a combination of PD-1 inhibitor camrelizumab and VEGFR inhibitor rivoceranib—citing unresolved manufacturing lapses at a Hengrui-owned plant in China.
This is the second time the FDA has issued a complete response letter (CRL) over chemistry, manufacturing, and control deficiencies tied to camrelizumab’s production.
HLB Chairman Jin Yang-gon speaks in a YouTube broadcast early Friday, confirming the FDA’s rejection of CAM-RIVO and outlining plans to address Hengrui’s manufacturing issues.
HLB Chairman Jin Yang-gon speaks in a YouTube broadcast early Friday, confirming the FDA’s rejection of CAM-RIVO and outlining plans to address Hengrui’s manufacturing issues.
HLB Chairman Jin Yang-gon, in a 3 a.m. YouTube video on Friday, said the rejection came despite both HLB and Hengrui being confident they had addressed the FDA’s concerns.
“We spent the last ten months working nonstop, convinced we had done enough,” he said. “Now, I have to deliver disappointing news again.”
The first CRL, issued in May 2024, flagged two issues: camrelizumab’s chemistry manufacturing control (CMC) and bioresearch monitoring inspections. This time, the FDA zeroed in solely on unresolved CMC problems.
The CRL does not specify the exact deficiencies, Jin added, but Hengrui will work with the FDA to clarify what needs to be corrected. HLB plans to submit the CRL to the Korea Exchange for transparency, though confidentiality agreements prevent the company from disclosing the full document.
Meanwhile, Bristol Myers Squibb (BMS)'s Opdivo-Yervoy combo is advancing just as HLB’s timeline slips. The therapy won European approval this month and is now on track for an FDA decision by April 21.
HLB shares dropped 7.65 percent Thursday, closing at 66,400 won, as investors braced for the FDA’s decision. The company has been signaling a potential pivot to other indications, including adenoid cystic carcinoma (ACC) and bile duct cancer.
In a phase 2 trial for ACC, rivoceranib showed a 15.1 percent overall response rate (ORR) with tumor shrinkage in 85 percent of patients, though not all met the RECIST criteria for response.