Janssen's Rybrevant (amivantamab-vmjw) Receives the US FDA's Approval as the First Targeted Treatment for Patients with NSCLC with EGFR Exon 20 Insertion Mutations
Shots:
- The US FDA has granted accelerated approval which is based on P-I CHRYSALIS study assessing Rybrevant as a monothx. in patients metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations whose disease has progressed on or after platinum-based CT
- The FDA has also approved Guardant Health's Guardant360 CDx liquid biopsy blood test as a CDx for use with Rybrevant
- The approval follows the FDA’s BTD in Mar’2020 and to initiate PR of the BLA in Dec’2020. Rybrevant is a fully human bispecific antibody directed against EGFR and MET receptors
Ref: PR Newswire | Image: Janssen
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