According to a story from drugs.com, the pharmaceutical company Merck recently announced that the US Food and Drug Administration (FDA) has approved its drug pembrolizumab (marketed as Keytruda) as a treatment for squamous cell carcinoma affecting the head and neck. The therapy is for patients that have PD-L1 expressing tumors; the drug may be used either alone or as part of a combination regimen with platinum and fluorouracil chemotherapy.
About Head and Neck Squamous Cell Carcinoma
The vast majority of cases of head and neck cancer are a type called squamous cell carcinoma. This type can appear on the skin and within the lining of many hollow organs, such as those of the digestive and respiratory systems. The throat, nasal cavity, and mouth are also possible locations. There are a number of risk factors for squamous cell carcinoma of the head and neck, such as tobacco, alcohol, betel nuts, gastroesophageal reflux, stem cell transplant, HPV, Epstein-Barr virus, and a diet heavy in red meat, processed meat, and eggs. Symptoms include breathing difficulties, facial swelling, a sore throat that doesn’t heal, a lump or sore that doesn’t heal, bleeding, vocal changes, and difficulty swallowing. Treatments include targeted therapies, chemotherapy, surgery, radiation therapy, and photodynamic therapy. To learn more about squamous cell carcinoma of the head and neck, click here.
Keytruda and Head and Neck Cancer
Head and neck cancer has long been a particular challenge to treat as it is critical that the functions of the head and neck be preserved while also treating the disease effectively. Squamous cell carcinoma that recurs or metastasizes is even more difficult and has become an area of substantial unmet medical need. The approval of Keytruda gives this group of patients a new therapeutic option that has the potential to improve outcomes.
Keytruda has previously been approved under Accelerated Approval in 2016 but only following or during platinum-based chemo; now the drug can be used as a first line treatment. Patients should be aware that Keytruda is associated with severe side effects such as skin reactions, colitis, hepatitis, and kidney dysfunction. The release of new data from a phase 3 clinical trial that showed positive impacts has transitioned Keytruda from Accelerated Approval to full approval.
