This section highlights FDA-related milestones and regulatory updates for drugs developed by Merus (MRUS).
Over the past two years, Merus has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
petosemtamab and Zenocutuzumab. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Petosemtamab FDA Regulatory Timeline and Events
Petosemtamab is a drug developed by Merus for the following indication: For the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- petosemtamab
- Announced Date:
- May 22, 2025
- Indication:
- For the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)
Announcement
Merus N.V. announced interim clinical data as of a February 27, 2025 data cutoff from the ongoing phase 2 trial of the bispecific antibody petosemtamab in combination with pembrolizumab.
AI Summary
Merus N.V. announced interim clinical data from their ongoing phase 2 trial of the bispecific antibody petosemtamab in combination with pembrolizumab. Data as of the February 27, 2025 cutoff showed that among 43 evaluable patients with head and neck squamous cell carcinoma, the overall response rate was 63%, with several complete responses recorded. Additionally, the median progression-free survival reached 9 months while the overall survival rate was 79% at 12 months. These promising results suggest that the combination therapy may be more effective than pembrolizumab alone. Dr. Carla M. L. van Herpen emphasized the potential of petosemtamab to become a new standard of care, given the notable tumor shrinkage and durable responses observed so far. The findings will be presented at the 2025 ASCO Annual Meeting, adding to the growing interest in this innovative treatment approach.
Read Announcement- Drug:
- petosemtamab
- Announced Date:
- February 18, 2025
- Indication:
- For the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)
Announcement
Merus N.V announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) to petosemtamab in combination with pembrolizumab for the first-line treatment of adult patients with recurrent or metastatic programmed death-ligand 1 (PD-L1) positive head and neck squamous cell carcinoma (r/m HNSCC) with combined positive score (CPS) ≥ 1.
AI Summary
Merus N.V. announced that the FDA has granted Breakthrough Therapy designation (BTD) to petosemtamab combined with pembrolizumab for the first-line treatment of adult patients with recurrent or metastatic PD-L1 positive head and neck squamous cell carcinoma (r/m HNSCC) with a combined positive score (CPS) ≥ 1. This designation is based on interim clinical data from an ongoing Phase 1/2 trial, which showed a 67% response rate among evaluable patients. The BTD is expected to speed up the development and review process by giving the company more guidance from the FDA and allowing for rolling and priority reviews. Merus believes that the promising results and the FDA’s support could help make petosemtamab a new standard of care over existing therapies for this serious and life-threatening condition.
Read Announcement- Drug:
- petosemtamab
- Announced Date:
- December 16, 2024
- Indication:
- For the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)
Announcement
Merus N.V announced that the first patient has been dosed in the Company's phase 2 trial evaluating petosemtamab monotherapy in heavily pretreated (3L+) metastatic colorectal cancer (mCRC).
AI Summary
Merus N.V., a clinical-stage oncology company, has reached an important milestone by dosing the first patient in its phase 2 trial. The study is testing petosemtamab as a single-agent treatment for patients with metastatic colorectal cancer (mCRC) who have already undergone at least three lines of therapy (3L+ MCRC) and prior anti-EGFR treatment.
The trial will evaluate the safety and antitumor activity of petosemtamab in these heavily pretreated patients. The drug is designed to target both the EGFR and LGR5 receptors, which may help in better controlling the cancer by disrupting key growth signals. Merus plans to use the insights gained from this study to advance its innovative approach to cancer treatment, using their Biclonics® platform to potentially offer new options for patients in need.
Read Announcement- Drug:
- petosemtamab
- Announced Date:
- December 7, 2024
- Indication:
- For the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)
Announcement
Merus N.V. announced interim clinical data as of a July 5, 2024 data cutoff from the ongoing phase 1/2 trial of petosemtamab, a Biclonics® targeting EGFR and LGR5, in previously treated (2L+) patients (pts) with recurrent/metastatic (r/m) head and neck squamous cell carcinoma (HNSCC).
AI Summary
Merus N.V. reported interim clinical data as of July 5, 2024, from its ongoing phase 1/2 trial of petosemtamab in previously treated (2L+) patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). Petosemtamab is a Biclonics® antibody designed to target EGFR and LGR5. In the trial, 75 evaluable patients showed an overall response rate of 36%, with several complete responses noted, including one that has lasted over three years. The drug was generally well tolerated, and a revised administration schedule led to a meaningful reduction in infusion-related reactions. Investigators highlighted that the clinical outcomes, regardless of HPV status and EGFR expression, suggest petosemtamab could offer a new standard of care for HNSCC. These promising results support further investigation, including phase 3 trials combining petosemtamab and pembrolizumab in first-line PD-L1 expressing HNSCC patients.
Read Announcement- Drug:
- petosemtamab
- Announced Date:
- December 1, 2024
- Indication:
- For the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)
Announcement
Merus N.V announced the publication of an abstract regarding petosemtamab, a Biclonics® targeting EGFR and LGR5, in previously treated (2L+) patients (pts) with recurrent/metastatic head and neck squamous cell carcinoma (r/m HNSCC) on the European Society for Medical Oncology (ESMO®) Asia Congress website.
AI Summary
Merus N.V. announced the publication of an abstract on the European Society for Medical Oncology (ESMO®) Asia Congress website. The abstract details updated clinical data on petosemtamab (MCLA-158), a Biclonics® antibody targeting both EGFR and LGR5. It focuses on previously treated (2L+) patients with recurrent/metastatic head and neck squamous cell carcinoma (r/m HNSCC).
The data includes results from an initial expansion cohort at a 1500 mg dose and a new dose-comparison cohort that assessed both 1100 mg and 1500 mg levels. The findings reveal consistent and durable clinical responses, suggesting petosemtamab could offer meaningful efficacy in this heavily pretreated population. More detailed information, including safety data and additional efficacy results, will be presented at the upcoming ESMO Asia Congress 2024 in Singapore, with further discussion scheduled during a related conference call.
Read Announcement- Drug:
- petosemtamab
- Announced Date:
- September 30, 2024
- Indication:
- For the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)
Announcement
Merus N.V. announced that the first patient has been dosed in the Company's phase 3 trial evaluating the efficacy and safety of petosemtamab, a Biclonics® targeting EGFR and LGR5, in combination with pembrolizumab, compared to pembrolizumab as first line (1L) therapy for patients with PD-L1+ recurrent/metastatic head and neck squamous cell carcinoma (r/m HNSCC), referred to as the LiGeR-HN1 trial.
AI Summary
Merus N.V. announced that the first patient has been dosed in its phase 3 LiGeR-HN1 trial. This study will evaluate the efficacy and safety of petosemtamab—a Biclonics® antibody targeting EGFR and LGR5—when given in combination with pembrolizumab, compared to using pembrolizumab alone as first-line therapy. The trial is focused on adult patients with PD-L1+ recurrent/metastatic head and neck squamous cell carcinoma (r/m HNSCC), a challenging cancer with limited treatment options. Researchers will assess key outcomes such as overall response rate and overall survival, along with secondary endpoints like duration of response and progression-free survival. Approximately 500 patients are expected to be enrolled, with the trial building on promising phase 2 data that highlighted petosemtamab’s potential to offer a new standard of care in this difficult-to-treat disease.
Read Announcement- Drug:
- petosemtamab
- Announced Date:
- July 24, 2024
- Indication:
- For the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)
Announcement
Merus N.V. announced that the first patient has been dosed in the Company's phase 3 trial evaluating the efficacy and safety of petosemtamab, a Biclonics® targeting EGFR and LGR5, compared to investigator's choice of single agent chemotherapy or cetuximab in previously treated (2/3L) patients with recurrent/metastatic head and neck squamous cell carcinoma (r/m HNSCC) referred to as the LiGeR-HN2 trial.
AI Summary
Merus N.V. announced that the first patient has been dosed in its phase 3 LiGeR-HN2 trial. This study evaluates the safety and efficacy of petosemtamab, a Biclonics® antibody that targets both EGFR and LGR5, in patients with recurrent or metastatic head and neck squamous cell carcinoma who have already received previous treatments. In the trial, petosemtamab is compared to the investigator’s choice of either single-agent chemotherapy or cetuximab. The study aims to determine whether petosemtamab can offer a better treatment option for patients who have progressed after earlier lines of therapy. With enrollment planned for approximately 500 patients, the trial will assess key outcomes such as overall response rate, overall survival, duration of response, and progression-free survival.
Read Announcement- Drug:
- petosemtamab
- Announced Date:
- May 13, 2024
- Indication:
- For the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)
Announcement
Merus N.V. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for petosemtamab for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed following treatment with platinum based chemotherapy and an anti-programmed cell death receptor-1 (PD-1) or anti-programmed death ligand 1 (PD-L1) antibody.
AI Summary
Merus N.V. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to its product petosemtamab. This designation is for patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed after treatment with platinum-based chemotherapy and either an anti-programmed cell death receptor-1 (PD-1) or anti-programmed death ligand-1 (PD-L1) antibody.
The FDA’s decision allows Merus N.V. to benefit from an expedited development and review process for petosemtamab. This step is intended to potentially speed up the availability of effective therapy for patients who face limited treatment options after their cancer has not responded to standard protocols. The breakthrough therapy status underlines the urgent need for new treatments in this area of oncology and provides hope for improved outcomes for patients suffering from advanced HNSCC.
Read Announcement
Zenocutuzumab FDA Regulatory Timeline and Events
Zenocutuzumab is a drug developed by Merus for the following indication: Advanced pancreas cancer and other solid tumors harboring NRG1 fusions.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Zenocutuzumab
- Announced Date:
- February 5, 2025
- Indication:
- Advanced pancreas cancer and other solid tumors harboring NRG1 fusions
Announcement
Merus N.V. announced that the New England Journal of Medicine (NEJM) published results of the registrational phase 2 eNRGy trial for Bizengri® (zenocutuzumab), the first and only treatment indicated for adults with pancreatic adenocarcinoma or non–small cell lung cancer (NSCLC) that are advanced unresectable or metastatic and harbor a neuregulin 1 (NRG1) gene fusion who have disease progression on or after prior systemic therapy.
AI Summary
Merus N.V. announced that the New England Journal of Medicine published key results from the registrational phase 2 eNRGy trial for Bizengri® (zenocutuzumab). Bizengri® is the first and only treatment approved for 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 worsened after prior systemic therapy.
The published study demonstrated that Bizengri® shows durable efficacy and has a favorable safety profile in this patient group, which historically has had very limited effective treatment options. This trial is the first prospective study to directly target cancers with the rare NRG1 gene fusion, marking a significant milestone in addressing a challenging unmet medical need.
Read Announcement- Drug:
- Zenocutuzumab
- Announced Date:
- December 4, 2024
- Indication:
- Advanced pancreas cancer and other solid tumors harboring NRG1 fusions
Announcement
Merus N.V. announced today that the U.S. Food and Drug Administration (FDA) approved BIZENGRI® (zenocutuzumab-zbco), the first and only treatment indicated for adults with pancreatic adenocarcinoma or non–small cell lung cancer (NSCLC) that are advanced unresectable or metastatic and harbor a neuregulin 1 (NRG1) gene fusion who have disease progression on or after prior systemic therapy.
AI Summary
Merus N.V. announced that the U.S. Food and Drug Administration (FDA) approved BIZENGRI® (zenocutuzumab-zbco), marking a significant milestone for patients with advanced, unresectable, or metastatic pancreatic adenocarcinoma and non–small cell lung cancer (NSCLC) that contain the neuregulin 1 (NRG1) gene fusion. This approval is granted on an accelerated basis, specifically for adults whose disease progressed following prior systemic therapy. The approval is based on clinical trial data showing notable response rates and durations of response in patients with NRG1+ cancers. BIZENGRI® is the first and only available treatment that directly targets this genetic driver, meeting an important need for a patient population with limited treatment options. The therapy is expected to be available in the coming weeks, and Merus is working to ensure that patients have access through various support resources.
Read Announcement- Drug:
- Zenocutuzumab
- Announced Date:
- August 28, 2024
- Indication:
- Advanced pancreas cancer and other solid tumors harboring NRG1 fusions
Announcement
Foundation Medicine, Inc. announced a collaboration to develop Foundation Medicine's RNA platform as a companion diagnostic for Merus N.V.'s bispecific antibody zenocutuzumab (Zeno) to treat patients with neuregulin 1 fusion (NRG1+) cancer.
AI Summary
Foundation Medicine, Inc. announced a new collaboration with Merus N.V. to develop its RNA platform as a companion diagnostic for Merus’s bispecific antibody, zenocutuzumab (Zeno). Zeno is designed to treat patients with neuregulin 1 fusion (NRG1+) cancer by targeting and blocking the tumor-signaling pathway. It works by binding to HER2 and inhibiting the interaction between HER3 and its ligand NRG1, a process that can help slow tumor growth.
The RNA platform from Foundation Medicine can detect fusions in 318 genes and offers gene expression data for over 1,500 genes, providing additional details that may help identify more NRG1 fusions. This innovative diagnostic tool is expected to support healthcare providers in making informed decisions by accurately identifying patients who could benefit from Zeno treatment.
Read Announcement- Drug:
- Zenocutuzumab
- Announced Date:
- May 6, 2024
- Indication:
- Advanced pancreas cancer and other solid tumors harboring NRG1 fusions
Announcement
Merus N.V announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a Biologics License Application (BLA) for the bispecific antibody zenocutuzumab (Zeno) in patients with neuregulin 1 fusion (NRG1+) non-small cell lung (NSCLC) and NRG1+ pancreatic (PDAC) cancer.
AI Summary
Merus N.V. announced that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) for priority review. The application is for the bispecific antibody zenocutuzumab, also known as Zeno, which is being studied for use in patients with neuregulin 1 fusion (NRG1+) non-small cell lung cancer (NSCLC) and NRG1+ pancreatic (PDAC) cancer.
This development marks a significant milestone for Merus as the company develops treatments for these specific cancer types. The priority review designation by the FDA indicates that the agency recognizes the potential of Zeno to address serious and life-threatening conditions. If approved, this therapy could provide a new treatment option for patients who suffer from cancers with NRG1 fusions, offering hope for a better future in combating these challenging diseases.
Read Announcement
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