Merus N.V.'s Bizengri has been granted FDA approval for use in adults with advanced unresectable or metastatic pancreatic adenocarcinoma or non-small cell lung cancer (NSCLC) that harbor a neuregulin 1 (NRG1) gene fusion and have experienced disease progression after previous systemic therapy. This approval marks a significant milestone for Merus as Bizengri is the company's first approved medicine, developed using their proprietary Biclonics technology platform.
The accelerated approval for Bizengri in these specific indications is based on data from the eNRGy trial, which demonstrated promising results in patients with NRG1-positive pancreatic adenocarcinoma and NSCLC. In the trial, Bizengri showed an overall response rate of 40% in NRG1-positive pancreatic adenocarcinoma patients and 33% in NRG1-positive NSCLC patients, with varying durations of response observed in both cancer types.
Merus N.V. anticipates making the Bizengri 20 mg/mL Injection for Intravenous Use available to patients in the near future. The continued approval for these indications is contingent upon further verification and description of clinical benefit in confirmatory trials. Additionally, the company's investor focus is currently on petosemtamab, with upcoming key data for its use in previously treated head and neck squamous cell carcinoma (HNSCC) expected to be presented at ESMO Asia on December 7th. Furthermore, an analyst estimates the pricing of Bizengri to be around $30,000 per treatment, with a projected peak U.S. sales figure of approximately $16.5 million based on royalties. As of Thursday, Merus N.V.'s stock price was down 3.70% at $43.80.