Today, FDA granted accelerated approval to sevabertinib (Hyrnuo, Bayer HealthCare Pharmaceuticals Inc.), a kinase inhibitor, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. https://lnkd.in/gvSrmYwx This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. FDA also approved the Oncomine Dx Target Test (Life Technologies Corporation) as a companion diagnostic device to aid in detecting HER2 (ERBB2) TKD activating mutations in patients with non-squamous NSCLC who may be eligible for treatment with sevabertinib. The prescribing information includes warnings and precautions for diarrhea, hepatotoxicity, and embryo-fetal toxicity. Learn more in the FDA-approved prescribing information at: https://lnkd.in/emUfeBq
Congratulations Bayer team!!! #Sevabertinib’s approval marks a significant step forward for #HER2-mutant non-squamous #NSCLC, offering a highly active, targeted therapy for patients who have limited options—a clear win for #precisiononcology.
Congratulations!
One targeted drug at a time. We can beat cancer!
Jim, Grats on the new gig! You’ll kill it!
Another important step forward for targeted lung cancer therapies.
This accelerated approval of sevabertinib marks a significant advancement for adults battling locally advanced or metastatic non-squamous non-small cell lung cancer with specific HER2 mutations. The integration of Project Orbis underscores the power of international collaboration in expediting critical oncology treatments. Additionally, the approval of the Oncomine Dx Target Test as a companion diagnostic enhances precision medicine by ensuring the right patients are identified for this targeted therapy. Safety considerations such as diarrhea, hepatotoxicity, and embryo-fetal toxicity remain important for clinicians to monitor. 👩⚕️🧬 A pivotal step forward in personalized lung cancer care! For More, visit our page: marketaccesstoday.com #DrugApproval #FDA #HealthcareInnovation #LungCancer #Oncology #PrecisionMedicine #MarketAccess #MarketAccessToday
Kudos to FDA's patient centric approach.
Congrats #teambayer great achievement for patients!