It seems like Keytruda (pembrolizumab) indications keep expanding after yesterday’s FDA approval.
The drug is a humanized antibody used in cancer immunotherapy that treats skin cancer, lung cancer, head and neck cancer, Hodgkin lymphoma, stomach cancer, and cervical cancer.
Now, the FDA has approved the Keytruda – developed by Merck – for adjuvant treatment of renal cell carcinoma (RCC) – the most common kind of kidney cancer found in adults. The drug is approved for patients who are at intermediate-high or high risk of recurrence after nephrectomy or following nephrectomy and resection of metastatic lesions, according to BioSpace.
Dr. Toni Choueiri, Director of Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, said, “Despite decades of research, limited adjuvant treatment options have been available for earlier-stage renal cell carcinoma patients who are often at risk for recurrence.”
“In KEYNOTE-564 [Phase 3 trial], pembrolizumab reduced the risk of disease recurrence or death by 32%, providing a promising new treatment option for certain patients at intermediate-high or high risk of recurrence,” he added. “With this FDA approval, pembrolizumab may address a critical unmet treatment need and has the potential to become a new standard of care in the adjuvant setting for appropriately selected patients.”
Adjuvant treatment is often recommended after initial cancer treatment, especially to suppress the formation of secondary tumors.
RCC is one of the most common types of kidney cancer, which is responsible for about 90% of renal cancer diagnoses. It is more common in men than women.
Most RCC cases are diagnosed when people undergo imaging studies for other abdominal issues.
Worldwide, more than 431,000 new cases of kidney cancer are diagnosed each year. In 2020 alone, the disease killed more than 179,000.
Dr. Scot Ebbinghaus, Vice President, Clinical Research, Merck Research Laboratories, said, “Keytruda is foundational for the treatment of patients with certain advanced cancers, and this approval marks the fourth indication for Keytruda in earlier stages of cancer.”
“Keytruda is now the first immunotherapy approved for the adjuvant treatment of certain patients with renal cell carcinoma,” he added. “This milestone is a testament to our commitment to help more people living with cancer.”
The story appeared Thursday on BioSpace.