Merus’ Bizengri (zenocutuzumab-zbco) has received accelerated approval from the US Food and Drug Administration (FDA), marking “an important milestone” in the treatment of cancers with a neuregulin 1 (NRG1) gene fusion, according to the principal investigator of the company’s ongoing trial.

The drug is the first systemic therapy approved by the FDA for the treatment of advanced, unresectable or metastatic pancreatic adenocarcinoma or non-small cell lung cancer (NSCLC) that are NRG1-positive (NRG1+) for patients who have disease progression on or after prior systemic therapy.

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Bizengri’s accelerated approval follows results from the eNRGy trial (NCT02912949), a multicentre, open-label clinical trial that included 30 patients with NRG1+ pancreatic adenocarcinoma and 64 with NRG1+ NSCLC. The former demonstrated an average overall response rate (ORR) of 40% while the latter experienced an average ORR of 33%.

Continued approval for the use of Bizengri in treating NRG1+ lung and pancreatic cancers will be contingent upon verification and description of clinical benefit in confirmatory trials.

Principal investigator of Merus’ eNRGy trial Alison Schram said: “The FDA approval of Bizengri marks an important milestone for patients with pancreatic adenocarcinoma or NSCLC that is advanced unresectable or metastatic and harbours the NRG1 gene fusion.

“I have seen firsthand how treatment with Bizengri can deliver clinically meaningful outcomes for patients.”

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The drug will become available in the coming weeks, in the form of a 20mg/ml injection for intravenous use. It holds a boxed warning for risks of embryo-fetal toxicity, as well as infusion-related reactions (IRRs), hypersensitivity and anaphylactic reactions, interstitial lung disease (ILD) or pneumonitis and left ventricular dysfunction.

The FDA’s approval of Bizengri for pancreatic and lung cancers follows Merus’ success in finding a commercialisation partner for the drug earlier this week. It announced on 2 December that it would exclusively license Bizengri to Partner Therapeutics for its commercialisation in the US.

Merus’ chief commercial officer Shannon Campbell said: “This approval is a testament to both our technology and strong execution as we continue to develop our multispecific platforms and pipeline, including our lead asset petosemtamab.”

The company shared updated clinical data from its Phase II trial for the use of petosemtamab for the treatment of head and neck squamous cell carcinoma on 1 December, ahead of its presentation at the European Society for Medical Oncology (ESMO) Asia Congress, on 7 December.