Lung cancer is one of the deadly disease responsible for many deaths all around the world. US Food and Drug Administration (FDA) has granted accelerated approval to Sevabertinib (Hyrnuo Bayer HealthCare Pharmaceuticals Inc.) for locally advanced or metastatic, non-squamous non-small cell lung cancer. The approval marks the first cancer therapy developed from Broad Institute-led discoveries. FDA has also approved the Oncomine Dx Target Test as a companion diagnostic device to aid in detecting HER2 (ERBB2) TKD activating mutations in patients with non-squamous NSCLC who are eligible for treatment with Sevabertinib.
About Sevabertinib
Sevabertinib is an oral targeted therapy for a specific form of NSCLC. This approval provides a new treatment option for those whose tumors habor the relevant molecular alterations. The discovery was the culmination of a 12-year long partnership between Broad Institute and Bayer HealthCare Pharmaceuticals.
Clinical Trial Findings
The researchers have conducted clinical trials and found that among those treated with Sevabertinib, 70% of patients had their tumors shrink or even disappear. Based on the strong findings in the first two rounds of clinical trials, FDA has approved the drug for distribution even before researchers had completed third phase of clinical trial.
Dosage and Side Effects
The most common reactions with treatment included Diarrhea, rash, paronychia and nausea. The drug is supplied as 10mg tablets and the recommended dose is 20mg twice daily with food until disease progression.
Regulatory Pathway
This review was conducted under Project Orbis, an initiative of the FDA Oncology center of excellence. This application was granted priority review. Sevabertinib received breakthrough designation and orphan drug designation. Healthcare professionals should report serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System.
The information shared in this blog is for educational purposes only. You should always consult with your healthcare professional for any medical needs.
Subscribe to our newsletter or follow us on Facebook or X today to stay informed and never miss an update!