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FDA Approves Combination Therapy for Bladder Cancer: A Significant Leap in Cancer Treatment

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Ayanna Amadi
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FDA Approves Combination Therapy for Bladder Cancer: A Significant Leap in Cancer Treatment

FDA Approves Combination Therapy for Bladder Cancer: A Significant Leap in Cancer Treatment

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The U.S. Food and Drug Administration (FDA) has granted approval to Astellas Pharma's drug Padcev and Merck's Keytruda for the treatment of advanced bladder cancer. The approval of these drugs represents a significant stride in the field of cancer treatment, providing new therapeutic options for patients with advanced bladder cancer who have previously received platinum-containing chemotherapy and a PD-1/L1 inhibitor.

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First and Only ADC Plus PD-1 Treatment for Advanced Bladder Cancer

Padcev (enfortumab vedotin ejfv) with Keytruda (pembrolizumab) has become the first and only antibody-drug conjugate (ADC) plus programmed cell death protein 1 (PD-1) treatment approved by the FDA to treat advanced bladder cancer. The approval of this combination therapy is grounded on the results of the Phase 3 EV 302 clinical trial. The trial revealed that the combination of the two drugs nearly doubled the median overall survival (OS) and median progression-free survival (PFS) in patients with previously untreated locally advanced or metastatic urothelial cancer compared to those on platinum-containing chemotherapy.

Significant Reduction in Risk of Death and Cancer Progression

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The combination of Padcev and Keytruda resulted in a median OS of 31.5 months and a median PFS of 12.5 months, indicating a significant reduction in the risk of death and cancer progression or death, respectively. This breakthrough in cancer treatment underscores the importance of collaborative efforts in advancing medical innovation, as well as the ongoing endeavors to improve cancer treatment.

Potential Side Effects of Combination Therapy

As with most cancer treatments, the combination therapy of Padcev and Keytruda does come with potential side effects. The most commonly reported adverse events in relation to the treatment with enfortumab vedotin and pembrolizumab include elevated aspartate aminotransferase, creatinine, glucose, lipase, peripheral neuropathy, and reduced lymphocytes. However, the safety results from the EV 302 trial are consistent with those previously reported for this combination in cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer.

A Win for Astellas and A Paradigm Change in Cancer Treatment

This FDA approval marks a significant achievement for Astellas Pharma, following the FDA's approval of their chronic eye disease drug, Izervay, in August. Alongside this, the combination of Padcev and Keytruda has been dubbed the 'new standard of care' in first-line bladder cancer, marking a paradigm change in the treatment of advanced bladder cancer. The approval of this combination therapy offers hope to the thousands of Americans affected by this aggressive disease and signifies a substantial improvement in cancer treatment strategies.

Bladder Cancer Cancer Chronic Eye Disease
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