Janssen’s JNJ-6372 Receives the US FDA’s Breakthrough Therapy Designation for Non-Small Cell Lung Cancer

Janssen’s JNJ-6372 Receives the US FDA’s Breakthrough Therapy Designation for Non-Small Cell Lung Cancer

Shots:

  • The FDA’s BT designation is based on a P-I study assessing the safety, efficacy & PK of JNJ-6372 as monothx. or in combination with lazertinib in patients with advanced NSCLC with EGFR Exon 20 insertion mutations, having disease progression on or after platinum-based CT
  • The study aims to determine the recommended P-II dose in patients with advanced NSCLC. The enrollment of patients is ongoing into part 2 dose expansion cohorts to assess JNJ-6372 as monothx. in multiple NSCLC sub-populations with genomic alteration
  • JNJ-6372 is an EGFR-MET bispecific Ab that targets activating and resistant EGFR and MET mutations and amplifications. The development of Ab followed the Janssen’s licensing agreement with Genmab for its DuoBody technology platform

Click here ­to­ read full press release/ article | Ref: JNJ | Image: Strait Times