FDA Approves Zynyz as First-Line Therapy for Advanced Anal Cancer

The U.S. Food and Drug Administration (FDA) has given approval for Zynyz (retifanlimab-dlwr), a novel humanized monoclonal antibody, to be used as the first-line treatment for patients with advanced anal cancer. This approval marks a significant advancement in the management of squamous cell carcinoma of the anal canal (SCAC), especially for those with inoperable, recurrent, or metastatic disease.

Zynyz functions as a programmed death receptor-1 (PD-1) inhibitor, boosting the immune system's ability to fight cancer. It is approved for use alongside carboplatin and paclitaxel, both chemotherapy agents, for treating eligible adult patients. Additionally, the FDA has approved Zynyz to be administered alone for patients whose cancer has progressed or who are intolerant to platinum-based chemotherapy.

The decision to approve Zynyz was supported by results from the phase 3 POD1UM-303/InterAACT2 clinical trial. The trial demonstrated a 37% reduction in the risk of disease progression or death when Zynyz was combined with chemotherapy, compared to placebo with chemotherapy. Patients receiving Zynyz experienced a median progression-free survival of 9.3 months versus 7.4 months with placebo, and an interim analysis showed an improvement of 6.2 months in median overall survival. Importantly, no new safety concerns emerged during this trial.

However, serious adverse reactions occurred in 47% of patients treated with Zynyz and chemotherapy. These included conditions such as sepsis (3.2%), pulmonary embolism (3.2%), diarrhea (2.6%), and vomiting (2.6%).

David Winterflood, CEO of the Anal Cancer Foundation, highlighted the importance of this approval, noting that it raises awareness for a condition often overlooked and provides new hope for patients with limited treatment options. The approval was granted to Incyte, the pharmaceutical company behind Zynyz.

This milestone emphasizes ongoing progress in immunotherapy and the need for increased awareness and research on anal cancer. For more information, visit the source.