In which countries is Amivantamab approved?

Introduction to Amivantamab 
Amivantamab is a fully-human bispecific monoclonal antibody designed to target both the epidermal growth factor receptor (EGFR) and the mesenchymal epithelial transition (MET) receptor. This dual-binding mechanism enables the drug to engage and downregulate both receptors, which are known to contribute to tumor growth and resistance to standard therapies in non‐small cell lung cancer (NSCLC). The unique structure of amivantamab not only blocks receptor signaling but also enhances immune cell recruitment against tumor cells. This drug has been developed primarily for the treatment of NSCLC patients whose tumors harbor EGFR exon 20 insertion mutations and who have experienced disease progression following platinum-based chemotherapy. 

Description and Mechanism of Action 
Amivantamab achieves its antitumor effects through several mechanisms. First, its bispecific nature allows simultaneous engagement of EGFR and MET, interfering with downstream signaling pathways that drive proliferation and survival in cancer cells. Additionally, the antibody’s Fc region recruits immune effector cells (such as natural killer cells, monocytes, and macrophages) to induce cell death via antibody-dependent cellular cytotoxicity (ADCC) and trogocytosis, a process by which parts of the tumor cell membrane are “nibbled” away by immune cells. This multiple-action profile helps overcome resistance mechanisms seen with other targeted therapies and improves clinical outcomes in patients with advanced NSCLC. 

Therapeutic Indications 
The primary therapeutic indication for amivantamab is in the treatment of adult patients with locally advanced or metastatic NSCLC harboring specific EGFR mutations—most notably, EGFR exon 20 insertion mutations. These mutations have been notoriously challenging to target with conventional EGFR inhibitors due to their unique structural challenges and inherent resistance. Amivantamab is approved for use both as a monotherapy in patients who have progressed on or after platinum-based chemotherapy and, in some regions, in combination with chemotherapy regimens. Its approval is supported by extensive clinical trial data demonstrating meaningful improvements in response rates, duration of response, and overall survival in this specific patient population. 

Regulatory Approval Process 
Understanding the regulatory approval process for new therapies is critical to appreciating the detailed pathways that bring innovative treatments like amivantamab to market. Accelerated approval mechanisms and rigorous clinical evaluations form the cornerstone of global drug approval strategies, providing patients with access to novel treatments as quickly as possible while ensuring safety and efficacy. 

Overview of Drug Approval Processes 
The pathway to regulatory approval typically involves preclinical studies, multiple phases of clinical trials (Phase 1 to Phase 3), and rigorous review processes by national and regional authorities. In scenarios where there is significant unmet medical need—such as advanced NSCLC with limited treatment options—regulatory agencies may offer accelerated approval or conditional marketing authorization based on surrogate endpoints and robust early data, followed by post-approval studies to confirm clinical benefit. Each country or region has developed specific frameworks to expedite the review of breakthrough and orphan therapies while continuing to uphold strict standards for patient safety. 

Key Regulatory Bodies Worldwide 
The worldwide landscape of regulatory authorities includes agencies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, and the National Medical Products Administration (NMPA) in China. In addition, South Korea’s regulatory authority and others—such as Health Canada—play pivotal roles in reviewing and approving new therapies. These agencies engage in intensive scientific dialogue with sponsor companies, contextualize clinical trial results against local standards of care, and determine post-marketing requirements aimed at ensuring continued safety surveillance and efficacy. 

Amivantamab Approval Status 
The approval status of amivantamab reflects its robust clinical profile and the regulatory attention it has garnered as a novel treatment option for NSCLC. The drug has successfully navigated the substantial regulatory hurdles in several major markets around the globe, where the evaluation fell under accelerated or conditional approval pathways given its potential to address a critical unmet medical need. 

Approved Countries 
Based on structured and reliable data from the synapse source results, amivantamab has achieved regulatory approvals in the following key countries and regions: 

• United States: Amivantamab received its first approval in the US on 21 May 2021, specifically for patients with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations. Its approval by the FDA was granted under an accelerated approval pathway due to the significant clinical benefits demonstrated in pivotal studies. 

• European Union: The drug is approved in member states of the European Union via a centralized marketing authorization process managed by the EMA. The official approval for the trade name Rybrevant (amivantamab) in an intravenous formulation, with a strength of 350 mg, was granted by the EMA, as indicated by the drug application number EMEA/H/C/005454. Furthermore, additional regulatory submissions, such as the type II extension applications, are in progress to expand the indications and combination regimens within Europe. 

• Japan: In Japan, amivantamab is approved through the PMDA. The relevant drug application, performed by Janssen Pharmaceutical KK, carries the application number 30600AMX00257000 with an approval date of 20 November 2024. This approval further confirms the extension of amivantamab’s availability in the Asian market under local regulatory standards. 

• China: Amivantamab is also approved in China as evidenced by the drug approval details provided for the application number 国药准字SJ20250005. The NMPA’s approval date is listed as 08 February 2025, with the drug being marketed under the trade names RYBREVANT and 鲜珂. This approval signals China's commitment to expanding access to innovative treatments for NSCLC, especially for patients with challenging EGFR mutations. 

In addition to the explicit approvals in these regions, amivantamab has also achieved noteworthy milestones in South Korea. Although a separate note indicates that amivantamab received Orphan Drug designation in South Korea on 15 February 2022, which underscores the recognition of its therapeutic potential under a specialized regulatory program, this designation may further support its expedited review and subsequent approval in the region once additional clinical data are provided. 

Approval Dates and Conditions 
Regulatory authorities have not only approved amivantamab in several countries but have also established specific conditions and timelines that influence its use in clinical practice. In the United States, the accelerated approval granted in May 2021 was contingent upon confirmatory trials to verify the drug’s clinical benefit, and the FDA continues to monitor safety and efficacy outcomes through real‐world evidence and ongoing studies. In Europe, the EMA’s approval followed a comprehensive review that not only considered clinical benefit but also evaluated safety profiles in the context of severe patient populations. The detailed labeling for Rybrevant includes specific dosage recommendations and administration routes (intravenous infusion of a concentrate for solution) tailored to maximize patient benefit and mitigate potential infusion-related reactions. In Japan and China, the respective PMDA and NMPA approvals similarly underline the drug’s favorable risk-benefit profile in specific patient subpopulations. The regulatory submissions in these regions have incorporated both clinical trial data and evidence from real-world settings, ensuring that the approvals are based on diverse and complementary sources of clinical evidence. 

Implications of Approval 
The approval status of amivantamab in multiple geographies has a number of significant implications for both market access and clinical treatment paradigms. These approvals not only enable broader availability of an innovative NSCLC therapy but also underscore the global recognition of the drug’s clinical value. 

Market Access and Availability 
With regulatory approvals secured in the United States, European Union, Japan, and China, amivantamab has achieved a wide market reach across major healthcare systems, thereby enhancing its commercial availability. The centralized European approval facilitates access in all EU member states, which combined with the US FDA approval, guarantees that patients in two of the world’s most influential markets benefit from this therapy. Furthermore, the recent PMDA and NMPA approvals extend access to critically important Asian markets, ensuring that patients in Japan and China can receive amivantamab as either a monotherapy or in combination with chemotherapy regimens. Additionally, the orphan drug designation in South Korea hints at an expedited pathway for eventual approval, broadening the drug’s reach even further in the region. This comprehensive global reach also supports manufacturing and distribution strategies that align with diverse regulatory requirements and market expectations. As countries observe the safety and efficacy performance of amivantamab in real-world settings, further market expansion and adaptation of treatment protocols are likely to follow. 

Impact on Treatment Options 
Amivantamab has significantly impacted the treatment landscape for NSCLC, particularly for a patient population with limited therapeutic options. By targeting EGFR exon 20 insertion mutations—a subgroup traditionally resistant to standard EGFR inhibitors—amivantamab offers a new line of therapy that improves clinical outcomes and extends survival. The drug’s approval under accelerated and conditional pathways in high unmet medical need areas reflects its transformative potential in the field of thoracic oncology. With clear regulatory endorsements across multiple jurisdictions, clinicians now have a robust addition to their therapeutic armamentarium. This is particularly crucial as early treatment initiation and precise molecular targeting have become key determinants of long-term patient benefit. Moreover, the multi-regional approvals signal a harmonization of clinical trial endpoints, risk mitigation strategies, and post-marketing surveillance approaches, which collectively enhance confidence among prescribers and payors in the drug’s safety and efficacy profile. 

Conclusion 
In summary, amivantamab is approved in several key markets worldwide, each with its own set of regulatory conditions and timelines that underscore its clinical value. The United States was the first country to approve amivantamab, with the FDA granting accelerated approval in May 2021 for the treatment of advanced NSCLC harboring EGFR exon 20 insertion mutations. Following this, the European Union has approved amivantamab via the centralized EMA process under the trade name Rybrevant. Additionally, Japan has approved the drug through the PMDA, with a confirmed approval date on 20 November 2024. In China, amivantamab is approved by the NMPA with an approval date specified as 08 February 2025, affirming its impending availability under the trade names RYBREVANT and 鲜珂. Furthermore, significant regulatory milestones such as the orphan drug designation in South Korea signal ongoing regulatory momentum that may soon translate into broader approvals in that region. 

This multi-regional approval status not only ensures broad market access but also reinforces the drug’s impact on advancing treatment options for a highly challenging subset of NSCLC patients. The convergence of regulatory data from structured sources like synapse further underlines the trust in the clinical data supporting amivantamab. From the initial breakthrough in the United States to the subsequent approvals in Europe, Japan, and China, the strategic regulatory and clinical approaches have played a pivotal role in paving the way for this innovative therapeutic agent. In the context of global oncology practice, these approvals translate into enhanced treatment paradigms that address specific genetic mutations and offer renewed hope for patients who previously had limited options. 

Ultimately, the comprehensive approval of amivantamab across these critical markets exemplifies not only a landmark achievement in drug development but also illustrates the power of global regulatory collaboration in expediting patient access to transformative therapies. Such multi-perspective approval narratives support the continued evolution of personalized medicine, ensuring that life‐extending and quality-of-life–improving treatments are made available to patients worldwide.

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