Bayer’s Sevabertinib Gets Priority Review for Treatment of Non-Small Cell Lung Cancer

Bayer’s sevabertinib gets priority review for treatment of non-small cell lung cancer

Bayer announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s new drug application (NDA) and granted priority review designation for the investigational compound sevabertinib (BAY 2927088), an oral, small molecule, tyrosine kinase inhibitor (TKI), for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptors 2 (HER2) (ERBB2) …

Subcutaneous Amivantamab Shows 13% Infusion Reaction Rate Compared to 66% with IV in NSCLC Treatment Study

A recent discussion highlighted findings from the PALOM […] The post Subcutaneous Amivantamab Shows 13% Infusion Reaction Rate Compared to 66% with IV in NSCLC Treatment Study first appeared on GeneOnline News. The post Subcutaneous Amivantamab Shows 13% Infusion Reaction Rate Compared to 66% with IV in NSCLC Treatment Study appeared first on GeneOnline News.

Sevabertinib Given FDA Priority Review for HER2+ NSCLC

The oral TKI sevabertinib has been granted priority review for use in patients harboring HER2 mutations in non-small cell lung cancer.

FDA Grants Priority Review to Sevabertinib NDA in HER2+ Lung Cancer

The FDA has accepted and granted priority review to an NDA for sevabertinib in previously treated HER2+ non-small cell lung cancer.

FDA Grants Priority Review to Sevabertinib in HER2-Mutant NSCLC

This priority review designation for sevabertinib in previously treated HER2-mutant non–small cell lung cancer is supported by data from the phase 1/2 SOHO-01 study.