FDA approves new drug for difficult-to-treat NRG1+ NSCLC

Hospital, holding hands and bed with doctor, support and care together

The U.S. Food and Drug Administration (FDA) has approved Bizengri (zenocutuzumab-zbco) as the first and only treatment indicated for adults with non-small cell lung cancer (NSCLC) or pancreatic adenocarcinoma that are advanced unresectable or metastatic and harbor a neuregulin 1 (NRG1) gene fusion, who have disease progression on or after prior systemic therapy.

According to a press release from Merus, the drug’s developer, the FDA approval fulfills an unmet need for patients who have NRG1+ cancer and previously have not had treatment options that target this specific driver. The approved indications are based on overall response rate (ORR) and duration of response (DOR) data from the eNRGy clinical trial.

“I have seen firsthand how treatment with Bizengri can deliver clinically meaningful outcomes for patients. I am extraordinarily grateful for the patients and families who participated in the trial,” said Alison Schram, MD, an attending medical oncologist in the Early Drug Development Service at Memorial Sloan Kettering Cancer Center and a principal investigator for the ongoing eNRGy trial.

In the multicenter, open-label study, patients with NRG1+ NSCLC (n=64) who were treated with Bizengri demonstrated an ORR of 33% (95% CI, 22%–46%). The median DOR in NRG1+ NSCLC was 7.4 months (95% CI, 4.0–16.6). Researchers measured response rates using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by blinded independent central review.

“In keeping with the growing number of personalized medicines on the market today, Bizengri offers the only approved NRG1+ therapy for patients with these difficult-to-treat cancers,” said Edward Abrahams, president of the Personalized Medicine Coalition, a Washington-based education and advocacy organization.

The FDA approval for Bizengri includes a Boxed Warning for embryo-fetal toxicity and warnings for infusion-related reactions (IRRs), hypersensitivity and anaphylactic reactions, interstitial lung disease (ILD)/pneumonitis and left ventricular dysfunction. Continued approval for the indications may be contingent upon verification and description of clinical benefit in additional confirmatory trials.

Merus said it plans to help qualified patients get access to Bizengri by providing resources and support based on individual patient need and situation.

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