Daily Tribune
[FILE PHOTO] A patient shows a Vulante tablet, a medication and specifically a combination of tenofovir disoproxil fumarate and lamivudine, used for the treatment of HIV infection in adults aged 18 years and older at his home in Msogwaba township near Mbombela on March 12, 2025. The halt to US foreign aid risks "reversing" gains hard won over decades of global efforts to contain the AIDS pandemic, the United Nations said Thursday. Around 31.6 million people were on antiretroviral drugs in 2024 and deaths from AIDS-related illnesses had more than halved since 2010, the UN's UNAIDS agency said in a new report, but infections were likely to rise as funding cuts have shuttered prevention and treatment programmes.
Phill Magakoe/AFP
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to zongertinib (brand name Hernexeos), a kinase inhibitor developed by Boehringer Ingelheim Pharmaceuticals, Inc., for the treatment of adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) harboring HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations. This approval applies to patients who have previously received systemic therapy.
Alongside this approval, the FDA authorized the use of the Oncomine Dx Target Test (Life Technologies Corporation) as a companion diagnostic to identify eligible patients with non-squamous NSCLC carrying HER2 TKD mutations.
The efficacy of zongertinib was evaluated in the Beamion LUNG-1 trial (NCT04886804), an open-label, multi-center study involving patients with unresectable or metastatic NSCLC with HER2 TKD mutations. The trial measured objective response rate (ORR) and duration of response (DOR) through blinded independent central review.
Among 71 patients who had undergone prior platinum-based chemotherapy but were new to HER2-targeted tyrosine kinase inhibitors or antibody-drug conjugates (ADCs), 75 percent showed a response to treatment, with 58 percent maintaining their response for six months or longer. For 34 patients previously treated with both platinum chemotherapy and HER2-targeted ADCs, the ORR was 44 percent, with 27 percent sustaining a response beyond six months.
The prescribing information for Hernexeos includes warnings about potential hepatotoxicity, left ventricular dysfunction, interstitial lung disease or pneumonitis, and embryo-fetal toxicity. The recommended dose varies by patient weight, with those under 90 kilograms advised to take 120 mg once daily, and those 90 kilograms or heavier prescribed 180 mg daily. The medication may be taken with or without food and is continued until disease progression or unacceptable toxicity occurs.
This approval was facilitated by the FDA’s Real-Time Oncology Review (RTOR) pilot program and the Assessment Aid, which allowed for an expedited evaluation process. Zongertinib also received breakthrough therapy and fast track designations, enabling priority review.
