Bayer announced that the investigational compound sevabertinib has been granted Priority Review status by the US Food and Drug Administration (FDA) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptor 2 (HER2/ERBB2) mutations and who have received a prior systemic therapy. Sevabertinib is an oral, small molecule, tyrosine kinase inhibitor (TKI).

“Patients with HER2-mutant NSCLC are predominantly women, may be of younger age and non-smokers. The FDA’s decision to grant Priority Review designation to our application for sevabertinib is a significant milestone that validates both the unmet need and the potential for sevabertinib to fulfill that need,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “If approved, sevabertinib will help address critical unmet needs and improve outcomes for these patients, who currently have a poor prognosis and limited treatment options.”

The regulatory application for sevabertinib is based on positive results from the ongoing Phase I/II SOHO-01 trial in patients with advanced NSCLC harboring a HER2-activating mutation, with disease progression after ≥1 systemic therapies for advanced disease, and who were naïve to treatment with a HER2-targeted TKI.

The Breakthrough Therapy designation for sevabertinib was supported by preliminary clinical evidence from the SOHO-01 trial. A Breakthrough Therapy designation is specifically designed to expedite the development and review of investigational medicines that have the potential to provide substantial improvement over available therapies in areas of high unmet medical need. By expediting the development and review process via a Breakthrough Therapy designation, promising therapies can be made available to patients as quickly and as safely as possible.

Sevabertinib is an investigational agent and has not been approved by any health authority for use in any country, for any indication. It is currently being evaluated as a potential new targeted treatment option for patients with NSCLC harboring human epidermal growth factor receptors 2 (HER2) activating mutations.