FDA Grants Accelerated Approval to Zenocutuzumab for Certain Patients With NSCLC

The US Food and Drug Administration (FDA) has granted accelerated approval to zenocutuzumab-zbco (Bizengri, Merus N.V.) for adults with advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) who have an NRG1 gene fusion with disease progression on or after prior systemic therapy.

“This represents the first FDA approval of a systemic therapy for patients with NSCLC or pancreatic adenocarcinoma harboring an NRG1 gene fusion,” FDA officials said in a news release.

The efficacy of the treatment was evaluated in the eNRGy study. The multicenter, open-label, multicohort trial enrolled 64 adults with advanced or metastatic NRG1 fusion-positive NSCLC and 30 adults with advanced or metastatic NRG1 fusion-positive pancreatic adenocarcinoma who had disease progression following treatment with the standard of care. The study investigators prospectively determined NRG1 gene fusion status with next-generation sequencing assays.

The primary efficacy outcome measures included confirmed overall response rate (ORR) and duration of response (DOR), determined by blinded independent central review according to RECIST v1.1. For patients with NSCLC, the ORR was 33%, with a median DOR of 7.4 months. For patients with pancreatic adenocarcinoma, the ORR was 40% and the DOR range was 3.7-16.6 months.

In the pooled safety population, the most common adverse reactions were diarrhea, musculoskeletal pain, fatigue, nausea, infusion-related reactions, dyspnea, rash, constipation, vomiting, abdominal pain, and edema, according to the FDA. The most common grade 3 or 4 laboratory abnormalities were increased gamma-glutamyl transferase, decreased hemoglobin, decreased sodium, and decreased platelets.

The prescribing information includes a Boxed Warning for embryo-fetal toxicity.

Source: FDA