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Amivantamab FDA Approval Status

FDA Approved: No
Generic name: amivantamab
Treatment for: Non-Small Cell Lung Cancer

Amivantamab is an investigational, fully-human EGFR-MET bispecific antibody in development for the treatment of metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

Development Timeline for amivantamab

DateArticle
Dec  3, 2020Janssen Submits Application to U.S. FDA Seeking Approval of Amivantamab for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
May 18, 2020Janssen Announces Phase 1 Results for Bispecific Antibody Amivantamab in the Treatment of Patients with Advanced Non-Small Cell Lung Cancer Harboring Exon 20 Insertion Mutations

Further information

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