The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Zynyz (retifanlimab) in combination with carboplatin and paclitaxel (platinum-based chemotherapy). 

If it is approved by the European Commission it will be the first PD-1 immunotherapy treatment for patients with advanced squamous cell carcinoma of the anal canal (SCAC) in Europe. 

“Today’s positive CHMP opinion is an important step towards addressing the urgent need for new treatment options for patients in Europe with advanced SCAC, a disease which has seen limited innovation for decades,” said Lee Heeson, Executive Vice President and Head of Incyte International. “If approved, Zynyz in combination with platinum-based chemotherapy has the potential to become a new standard-of-care for patients living with this rare and difficult-to-treat cancer.” 

The positive CHMP opinion was based on data from the Phase III POD1UM-303/InterAACT2 trial evaluating Zynyz in combination with (platinum-based chemotherapy) in adult patients with metastatic or inoperable locally recurrent SCAC not previously treated with systemic chemotherapy. 

Results from trial showed a statistically significant 37% reduction in the risk of progression or death. Patients in the Zynyz and platinum-based chemotherapy combination group achieved a median progression-free survival (PFS) of 9.3 months compared to 7.4 months for patients in the placebo combination group. 

Serious adverse reactions occurred in 47% of patients receiving Zynyz in combination with chemotherapy. 

SCAC is the most common type of anal cancer, accounting for approximately 85% of all anal cancer cases. Globally, the prevalence of SCAC is estimated at around one or two cases per 100,000 people. 

The CHMP opinion is now being reviewed by the European Commission, which has the authority to grant approval for all centrally authorised products in the EU.