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

May 24, 2021 Auto Bot approval, FDA, Janssen, NSCLC, regulatory, Rybrevant 0

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

Click here to­ read full press release/ article | Ref: PRNewswire | Image: Publico

The post 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 first appeared on PharmaShots.