The FDA granted accelerated approval for the first immunotherapy treatment for adults with recurrent respiratory papillomatosis.
The US Food and Drug Administration (FDA) granted the American biotech company Inovio Pharmaceuticals accelerated approval for the use of the drug Voceryq (doruxapapogene rlaplasmid and larkinogen sifuplasmid-gxfd) in adult patients with recurrent respiratory papillomatosis (RRP).
The disease is characterized by the appearance of warty tumors in the throat and respiratory tract and is usually caused by HPV types 6 and 11. The tumors are not malignant, but they appear all the time even after surgical treatment. Over time, papillomas can cause throat cancer.
The appearance of tumors often leads to hoarseness, chronic cough and voice changes - in severe cases they may spread to other parts of the respiratory tract and cause breathing difficulties. The main treatment option is surgery, which removes the tumors, but does not get rid of the root of the disease. Therefore, patients have to undergo repeated procedures over many years.
Voceryq is the first drug approved in the United States for plasmid DNA-based immunotherapy. Its use is aimed at eliminating the root cause of recurrent polyposis and reducing the need for surgical intervention. Immunotherapy uses the patient's own immune system to fight the underlying cause of RRP.
The safety and efficacy of Voceryq were evaluated in an open-label, multicenter clinical trial involving 32 adult patients diagnosed with laryngeal cancer. Eligible patients had undergone two or more operations to remove laryngeal papillomas in the 12 months prior to starting drug treatment, including elective surgery at the time of study entry.