The FDA recently approved a new ORAL therapy, Hernexeos (zongertinib tablets) from Boehringer Ingelheim, indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) and whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations. Hernexeos is a tyrosine kinase inhibitor therapy. Hernexeos is being evaluated in ongoing trials, across a range of advanced solid tumors with HER2 alterations.
Lung cancer remains the leading cause of cancer-related deaths worldwide, with cases projected to surpass 3 million annually by 2040. Non-small cell lung cancer (NSCLC) accounts for the majority of diagnoses. Because early symptoms are often absent or misinterpreted, most patients are not identified until stage III or IV, when the disease has already spread to organs.
The company did not confirm pricing at the time of approval. A market analyst suggests that “Hernexeos will launch with an estimated $100,000 annual treatment cost and 10,000 eligible patients in the U.S., Hernexeos could generate $1 billion in peak sales—a figure that could rise with label expansions into first-line therapy or other HER2-mutant cancers.”
Onco360 Specialty Pharmacy has been selected as LD partner to distribute Hernexeos.
CLICK HERE to access prescribing information
U.S. FDA grants accelerated approval to Boehringer’s Hernexeos as first orally administered targeted therapy for previously treated patients with HER2-mutant advanced NSCLC
CLICK HERE to read the company press release
