According to a story from Pharmabiz, pharmaceutical company Merck has announced recently that the European Commission has approved a combination of pembrolizumab (marketed as Keytruda) and enfortumab vedotin-ejfv (marketed as Padcev) as a first line treatment for adults living with urothelial carcinoma (the most common form of bladder cancer) that is metastatic (meaning it has spread beyond the tissue of origin) or cannot be treated with surgery. The approval followed updated guidelines from the European Association of Urology and the European Society for Medical Oncology, who recommended the approach.
The commission also received a recommendation for approval from the Committee for Medicinal Products for Human Use over the summer following results from a phase 3 trial designated KEYNOTE-A39. In this clinical trial, the combination displayed advantages in progression-free survival (PFS) and overall survival when compared to platinum-based chemotherapy. With a median follow up of 17.3 months, the combination also produced a 53% reduction in death risk, as well as a reduction in risk of disease progression or death of 55%.
With these results, people living with this cancer have the opportunity to receive a first-line approach that has a substantial chance of extending their lifespan. Evaluation of the combination for different stages of this cancer is ongoing in additional phase 3 studies.
About Bladder Cancer
Bladder cancer is cancer that affects the bladder, a hollow organ of the urinary system. There are multiple types of bladder cancer, with the most common type being urothelial carcinoma (also called transitional cell carcinoma). There is no known direct cause of bladder cancer, but a number of risk factors have been identified. The strongest is tobacco smoking; others include being male, opium use, exposure to a number of widely used chemicals, family history, frequent bladder infections, and radiation therapy. Symptoms include painful urination, bloody urine, frequent urination, swelling of the lower extremities, and pain affecting the flank, bones, or pelvis. A number of treatments may be tried for muscle invasive bladder cancer, such has surgery, immunotherapy, and chemotherapy. Outcomes for non-muscle invasive disease are better than other forms of bladder cancer, with a five-year survival rate of 95%. However, around 70% of these patients will face recurrence, and 30% will progress to muscle invasive disease. To learn more about bladder cancer, click here.
bladder cancer news treatment urothelial carcinoma
Last modified: October 17, 2024
