Home Amivantamab Subcutaneous Injection Approved in China for EGFR-Mutated NSCLC with 5-Minute Administration

Amivantamab Subcutaneous Injection Approved in China for EGFR-Mutated NSCLC with 5-Minute Administration

Dec 26, 2025 00:01 CST Updated 00:01
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Instructions for Use of Amivantamab Injection
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Yesterday (December 25), Johnson & Johnson announcedAmivantamab Injection (Subcutaneous Injection)Officially approved by the National Medical Products Administration (NMPA) for the treatment of patients with advanced non-small cell lung cancer (NSCLC) carrying epidermal growth factor receptor (EGFR) mutations. Specific indications are the same as for Amivantamab Injection: 1)Combined with Lanreotide forEGFR19delor L858R mutation in locally advanced or metastaticNSCLCFirst-line Treatment for Adult Patients2)First-line treatment for adult patients with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutationsAnd3)For adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer whose disease has progressed during or after EGFR-TKI treatment.
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Source: Johnson & Johnson Innovation WeChat Official Account

May 2021(Click)U.S. FDAApproval of Amivantamab for the treatment of advanced NSCLC patients with EGFR 20ins whose disease has progressed after failure of platinum-based chemotherapy.March 2024`, Amivantamab received`Fully approved by the U.S. FDA, in combination with chemotherapy for first-line treatment of locally advanced or metastaticEGFRExon20Insertion MutationPatients with NSCLC.August 2024The US FDA Approves Amivantamab + Lazertinib for First-Line Treatment of Adult Patients with Locally Advanced or Metastatic NSCLC Harboring EGFR 19del or L858R MutationsMedian OS Improved by More Than One YearDecember 17, 2025United StatesFDAApprovalAmivantamab Subcutaneous Injection(Product Name:Rybrevant Faspro)Launch, with an indication range similar to the intravenous formulation(Product Name:Rybrevant)Exactly the same.

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Amivantamab is under Johnson & Johnson.Johnson & Johnson Innovative MedicineDevelopedA bispecific antibody under research that targets EGFR and MET. In addition to blocking EGFR and MET-mediated signal transduction, it can also guide immune cells to target activating and resistant cells.EGFR/METTumors with Mutations and AmplificationsEvanmab subcutaneous injection takes only about 5 minutes to administer, with an 80% reduction in infusion-related adverse reactions compared to intravenous formulations.


This approval is mainly based onPositive results from the PALOMA-3 Phase III study and the PALOMA-2 Phase II study.

PALOMA-3 is a randomized, open-label Phase III study. It evaluates the non-inferiority in pharmacokinetics of subcutaneous amivantamab combined with lazertinib versus intravenous amivantamab combined with lazertinib in patients with EGFR-mutated locally advanced or metastatic NSCLC whose disease progressed during or after treatment with osimertinib and platinum-based chemotherapy. The study results showed that the subcutaneous formulation of amivantamab achieved blood drug concentration levels meeting the two co-primary pharmacokinetic endpoints, demonstrating its non-inferiority to the intravenous formulation.

PALOMA-2 is an open-label, parallel-cohort study designed to evaluate the efficacy, safety, and pharmacokinetic profile of subcutaneous amivantamab in patients with locally advanced or metastatic NSCLC carrying EGFR mutations. The study results show that the subcutaneous formulation of amivantamab is as effective as the previously approved intravenous formulation, while offering advantages in tolerability and ease of administration.

Patients receiving subcutaneous evolocumab combined with lenvatinib had an infusion-related adverse reaction rate only one-fifth of that in the intravenous formulation group (13% vs 66%). The incidence rates of venous thromboembolism (VTE) in the subcutaneous injection group were 7% and 17% for patients with and without prophylactic anticoagulation, respectively. Apart from the rates of IRR and VTE, the overall safety profile of the subcutaneous formulation of evolocumab was consistent with that of the intravenous formulation.

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