- Squamous cell carcinoma (SCC) of the anal canal is a rare but increasing malignancy, often linked to high-risk human papillomavirus.
- The drug approval is based on data from a late-stage study where Zynyz in combination with platinum-based chemotherapy demonstrated a statistically significant reduction in the risk of progression or death in the relevant patient population.
- The drug was previously approved in Europe for the first-line treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma, another rare cancer.
Incyte said on Friday that the European Commission has approved its Zynyz for yet another rare cancer, marking the drug’s second approval in the region.
The company said that the commission approved Zynyz in combination with carboplatin and paclitaxel for adult patients with metastatic or with inoperable locally recurrent squamous cell carcinoma of the anal canal.
Squamous cell carcinoma (SCC) of the anal canal is a rare but increasing malignancy, often linked to high-risk human papillomavirus (HPV). Anal cancer shares many of the same symptoms as non-cancerous conditions, such as hemorrhoids, increasing chances of it going undetected.
The drug was previously approved in Europe for the first-line treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma, another rare cancer.
The Approval Process
The European Medicines Agency’s Committee for Medicinal Products for Human Use had recommended approval for the drug in the new indication in January.
The approval is based on data from a late-stage study where Zynyz in combination with platinum-based chemotherapy demonstrated a statistically significant 37% reduction in the risk of progression or death in the relevant patient population.
Patients who received Zynyz and chemotherapy achieved a median progression-free survival of 9.3 months compared to 7.4 months for patients who received placebo and chemotherapy in the trial.
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