FDA Approves Keytruda for Head and Neck Cancer Treatment

MSD has secured approval from the United States Food and Drug Administration (FDA) for its PD-1 targeting therapy, Keytruda, aimed at treating adults with resectable, locally advanced head and neck squamous cell carcinoma (HNSCC). This approval specifically targets patients with tumors expressing PD-L1, characterized by a combined positive score (CPS) of 1 or greater, verified through an approved testing method by the US regulatory body.

The authorization is grounded in data derived from the pivotal Phase III KEYNOTE-689 trial. This trial supports the use of Keytruda as a solitary neoadjuvant therapy, which can be continued as adjuvant treatment in combination with radiotherapy. This combination can be administered with or without cisplatin, followed by continued therapy using Keytruda alone. Furthermore, the Oncology Center of Excellence initiative, Project Orbis, has facilitated a synchronized review of Keytruda, enhancing the efficiency of the review process.

Currently, marketing authorization applications for Keytruda are undergoing evaluation by health authorities across several countries, including Australia, Brazil, Canada, Israel, Singapore, and Switzerland. Additionally, regulatory bodies in Europe and Japan are deliberating over applications concerning Keytruda.

Dr. Marjorie Green, head of global clinical development in oncology at MSD Research Laboratories, expressed that this treatment regimen represents the inaugural perioperative anti-PD-1 treatment alternative for patients with suitable conditions of resectable, locally advanced head and neck squamous cell carcinoma. She highlighted the potential of this regimen to significantly alter the treatment landscape for patients and their families grappling with this disease. According to Dr. Green, Keytruda, when included in this regimen, has the capability to transform the long-standing standards of care for treating certain patients with locally advanced HNSCC.

Keytruda functions by bolstering the immune system's ability to identify and destroy tumor cells. This monoclonal antibody is engineered to inhibit the interaction between PD-1 and its ligands, PD-L1 and PD-L2. This blockade results in the activation of T lymphocytes, which affects both tumor and healthy cells. MSD's Keytruda is currently being explored in over 1,600 trials encompassing various cancer types and treatment settings.

Beyond Keytruda, MSD has also attained FDA approval for Enflonsia, a treatment designed to prevent lower respiratory tract disease caused by the respiratory syncytial virus in newborns and infants. This highlights MSD's ongoing commitment to expanding its portfolio of approved therapies and addressing diverse therapeutic needs.

Through these advancements, MSD continues to make significant strides in oncology and beyond, reinforcing its position as a leader in pharmaceutical innovation. These approvals not only underscore MSD's dedication to transforming treatment paradigms but also to improving patient outcomes across multiple disease areas.