카지노 바카라 becomes first approved adjuvant therapy in Korea for muscle-invasive bladder cancer pre- and post-surgery

[by Sung, Jae Jun] AstraZeneca Korea announced on August 4 that its immunotherapy drug 카지노 바카라 (durvalumab) received approval from the Ministry of Food and Drug Safety on July 30 for use as preoperative and postoperative adjuvant therapy for patients with muscle-invasive bladder cancer. With this approval, 카지노 바카라 becomes the first and only immunotherapy approved for this category in Korea.

The approval covers the use of 카지노 바카라 in combination with cisplatin and gemcitabine as a preoperative regimen, followed by 카지노 바카라 monotherapy in the postoperative setting. Muscle-invasive bladder cancer, a subtype in which the tumor penetrates the muscle layer of the bladder, constitutes approximately 20% of all bladder cancer cases. Due to its poor prognosis and high risk of recurrence, it presents significant therapeutic challenges. In fact, nearly 50% of patients experience disease relapse within three years of initial treatment.

This expanded indication was granted based on the findings of the global Phase 3 clinical trial (NIAGARA). The study compared four cycles of preoperative chemotherapy (cisplatin and gemcitabine) combined with 카지노 바카라, followed by surgical resection and eight cycles of postoperative 카지노 바카라 monotherapy, with a control group (chemotherapy followed by surgery alone).

The results demonstrated that the 카지노 바카라-treated group achieved a two-year event-free survival rate of 67.8%, representing a 32% reduction in the risk of disease progression, recurrence, failure to undergo surgery, or death compared to the control group (59.8%). Additionally, overall survival outcomes were improved, with a two-year survival rate of 82.2% in the 카지노 바카라 group, compared to 75.2% in the control group.

The safety profile observed in the trial was generally consistent with that of previously established 카지노 바카라 monotherapy and combination regimens. While immune-related adverse events were more frequently reported in the 카지노 바카라 group, their incidence remained within the anticipated range. Importantly, the rate of surgical intervention did not differ significantly between both groups.

카지노 바카라 is already designated as a Category 1 recommendation, the highest priority level, for preoperative and postoperative adjuvant therapy in the National Comprehensive Cancer Network (NCCN) guidelines. Additionally, it has received an ‘A’ rating, the highest score, in the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS).

"Conventional treatment approaches have struggled to improve survival outcomes due to the high rate of recurrence, but the introduction of adjuvant immunotherapy is anticipated to bring about a paradigm shift in the management of bladder cancer," expressed Professor Jeong Byong-chang from the Department of Urology at Samsung Medical Center (President of the Korean Urological Oncology Society).

"The rapid regulatory approval in Korea, just four months following approval by the U.S. Food and Drug Administration (FDA), underscores the clinical necessity and therapeutic value of 카지노 바카라 as preoperative and postoperative adjuvant treatment for muscle-invasive bladder cancer. We remain committed to expanding access to 카지노 바카라 for patients at earlier stages of the disease, with the aim of offering renewed hope for a cure," said Lee Hyun-joo, Executive Director of AstraZeneca Korea's Oncology Business Unit.