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