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
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