The Food and Drug Administration (FDA) has recently granted priority review to the combination of Keytruda (pembrolizumab) and Padcev (enfortumab vedotin-ejfv) for the treatment of urothelial cancer. This decision comes as a significant development in the field of oncology, offering new hope for patients with this aggressive form of cancer.
Urothelial cancer, also known as bladder cancer, is the sixth most common cancer in the United States. It primarily affects the urothelial cells that line the inside of the bladder, ureters, and other parts of the urinary system. Urothelial cancer can be challenging to treat, especially when it reaches an advanced stage or metastasizes to other organs.
Keytruda, developed by Merck, is an immune checkpoint inhibitor that works by blocking the PD-1 protein on immune cells, allowing them to recognize and attack cancer cells more effectively. It has been approved for various types of cancer, including melanoma, lung cancer, and head and neck cancer. Keytruda has shown promising results in clinical trials for urothelial cancer, leading to its approval as a monotherapy for certain patients.
Padcev, developed by Astellas Pharma and Seattle Genetics, is an antibody-drug conjugate that targets Nectin-4, a protein found on the surface of urothelial cancer cells. It delivers a potent chemotherapy drug directly to the cancer cells, minimizing damage to healthy tissues. Padcev received accelerated approval from the FDA in 2019 for the treatment of locally advanced or metastatic urothelial cancer that has progressed after platinum-based chemotherapy and immunotherapy.
The combination of Keytruda and Padcev aims to leverage the benefits of both drugs to provide a more effective treatment option for patients with urothelial cancer. The FDA’s decision to grant priority review status to this combination means that the agency will expedite its review process, potentially leading to a faster approval and availability of the treatment.
The priority review designation is reserved for drugs that offer significant improvements in the safety or effectiveness of the treatment of a serious condition. It shortens the review period from the standard ten months to six months, allowing patients to access potentially life-saving therapies sooner.
The decision to grant priority review to the Keytruda and Padcev combination was based on positive results from the Phase II EV-103 clinical trial. The trial evaluated the safety and efficacy of the combination in patients with locally advanced or metastatic urothelial cancer who had previously received platinum-based chemotherapy and immunotherapy.
Preliminary data from the trial showed promising response rates, with a significant proportion of patients experiencing tumor shrinkage. The combination therapy also demonstrated a manageable safety profile, with adverse events consistent with those previously reported for each drug individually.
If approved, the Keytruda and Padcev combination could become a new standard of care for patients with advanced urothelial cancer. It has the potential to improve overall survival rates and provide a much-needed treatment option for those who have exhausted other available therapies.
In conclusion, the FDA’s decision to grant priority review to the combination of Keytruda and Padcev for urothelial cancer represents a significant advancement in the field of oncology. This combination therapy offers new hope for patients with this aggressive form of cancer, potentially improving outcomes and extending survival. As further research and clinical trials continue, it is crucial to monitor the progress of this treatment and its impact on patients’ lives.
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- Source: Plato Data Intelligence.
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