On the 8th (local time), the U.S. Food and Drug Administration (FDA) announced the accelerated approval of zongertinib, an oral treatment for non-small cell lung cancer from the German pharmaceutical company Boehringer Ingelheim. Large non-small cell lung cancer accounts for 70% to 80% of all lung cancers.
Zongertinib is Boehringer Ingelheim's first anticancer drug and is set to be marketed under the brand name Hernexeos. Hernexeos has been approved for patients with recurrent non-small cell lung cancer who have mutations in HER2 (human epidermal growth factor receptor 2). This drug works by blocking abnormal cell signaling to inhibit cancer cell growth.
Boehringer Ingelheim noted that in clinical trials, 75% of the 71 patients experienced a reduction in tumors. Among them, 58% had this effect sustained for over six months. The median progression-free survival time for the patient group was 12.4 months. Overall, 96% of patients did not experience worsening of their condition. The five-year survival rate for patients with HER2 mutation progressive non-small cell lung cancer is less than 30%.
HER2 mutations are found in about 2% to 4% of all non-small cell lung cancer patients. The company estimates that this patient population is approximately 40,000 worldwide. This is the first time the FDA has approved an oral treatment for these patients. There was also ADC 'Enhertu' from AstraZeneca in the UK and Daiichi Sankyo in Japan, but it is administered intravenously and similar side effects to chemotherapy have been reported.
Dr. Joshua Savari, the lead researcher, said, 'Hernexeos is a targeted therapy with excellent selectivity and activity and fewer side effects.' He noted, 'It is expected to provide treatment benefits while maintaining a superior quality of life over an extended period.'
This approval was granted through the FDA's accelerated approval process, and confirmation data must be submitted in the future. Accelerated approval is a system designed to rapidly bring new drugs with advantages over existing medications to market and can shorten clinical trial durations. Boehringer Ingelheim is conducting Phase 3 clinical trials to expand the use of Hernexeos as a first-line treatment, along with studies for breast cancer, gastric cancer, and pan-tumor.
Boehringer Ingelheim is actively investing in the field of antineoplastic drugs, recently establishing an ADC research and development center with an investment of 27 million Swiss francs (approximately $33.6 million) in Basel, Switzerland. The company plans to launch Hernexeos alongside the idiopathic pulmonary fibrosis treatment 'Nerandomilast' within this year and aims to release 15 new drugs by 2030.