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FDA Approval Marks a Significant Advancement in Bladder Cancer Treatment

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Ethan Sulliva
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FDA Approval Marks a Significant Advancement in Bladder Cancer Treatment

FDA Approval Marks a Significant Advancement in Bladder Cancer Treatment

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In a significant development in the field of oncology, the U.S. Food and Drug Administration (FDA) has approved a combination therapy for bladder cancer. The treatment, which pairs Astellas Pharma's Padcev with Merck's Keytruda, now offers a promising new option for patients battling this condition. The approval underscores the importance of ongoing research and innovation in cancer care, with the combination therapy showing promising results in clinical trials.

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A New Hope for Bladder Cancer Patients

The FDA's approval for the combination of Padcev and Keytruda signifies a substantial advancement in bladder cancer treatment. Specifically, it offers a new treatment option for patients with advanced urothelial cancer who are not eligible for cisplatin-containing chemotherapy. The high response rate and manageable safety profile observed in the phase 1b/2 trial have led to this approval, offering new hope for patients battling this challenging cancer.

Superiority Over Chemotherapy

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Not only does this combination therapy offer another treatment avenue, but it has also proven superior to traditional chemotherapy. It has been approved as a first-line treatment for bladder cancer, reducing the risk of death by 53% compared to chemotherapy. The combined treatment has demonstrated a median overall survival rate of 31.5 months in a phase 3 study, compared to 16.1 months for chemotherapy. The combination is currently being investigated for additional uses, including as a standalone treatment and in combination with Keytruda for other types of cancer.

Improving Survival Rates

Further elevating its potential, the FDA-approved combination of PADCEV enfortumab vedotin ejfv with KEYTRUDA pembrolizumab nearly doubled median overall survival compared to the standard of care platinum-based chemotherapy. The Phase 3 EV 302 clinical trial demonstrated this increased survival rate, as well as improved progression-free survival in patients with previously untreated advanced bladder cancer.

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A New Standard of Care

With the FDA granting full approval to the Padcev-Keytruda combination for patients with locally advanced or metastatic urothelial cancer, this treatment is being hailed as the 'new standard of care' in first-line bladder cancer. This approval comes after confirmatory trial data reinforced its efficacy and safety.

Accelerated Approval Process

The approval for Astellas Pharma's Padcev and Merck's Keytruda was based on data from the Phase III EV-302 clinical trial and was granted under an accelerated process for patients unable to receive cisplatin chemotherapy. This study served as the confirmatory trial for the accelerated approval of this indication. It is important to note that the combination treatment may include some adverse effects such as elevated aspartate aminotransferase, creatinine, glucose, lipase, peripheral neuropathy, and lowered lymphocytes.

This FDA approval of the Padcev-Keytruda combination signifies a crucial step forward in the ongoing battle against bladder cancer, offering improved survival rates and a new standard of care for patients. It also highlights the importance of continued research and innovation in the field of oncology.

Bladder Cancer Cancer
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