FDA aprroval for first-of-its-kind lung cancer treatment

The US Food and Drug Administration (FDA) granted accelerated approval to (Hernexeos, Boehringer Ingelheim’s Hernexeos (zongertinib), the first orally administered, targeted treatment for adults with unresectable 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 prior systemic therapy.

This offers a convenient alternative to traditional infusion treatments. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial, the company noted.

“With the approval of zongertinib, we have an effective, targeted, orally administered treatment option for patients with HER2 (ERBB2)-mutant non-small cell lung cancer in the US that not only elicits a durable response but, importantly, has a manageable safety profile,” said Dr John Heymach, chairman of thoracic/head and neck medical oncology at The University of Texas MD Anderson Cancer Center, and coordinating investigator for the Beamion-LUNG 1 trial. “In a patient population where there are currently limited treatment options, this approval represents a significant advancement in cancer care.”