The designation enables to use of JNJ-6372 to treat patients with metastatic NSCLC with epidermal growth factor receptor (EGFR) Exon 20 insertion mutations, whose disease has advanced on or after platinum-based chemotherapy.
Janssen’s JNJ-6372, an EGFR-mesenchymal-epithelial transition factor (MET) bispecific antibody, has been designed to target activating and resistant EGFR and MET mutations and amplifications.
The FDA has granted breakthrough therapy status based on data from a phase 1, first-in-human, open-label and multicentre study.
Janssen has designed the trial to assess the safety, pharmacokinetics and preliminary efficacy of JNJ-6372 monotherapy. It is also assessed in combination with lazertinib, a novel third-generation EGFR TKI, in adult patients with advanced NSCLC.5
The study aims to determine the recommended phase 2 dose in patients with advanced NSCLC. The recruitment of patients is ongoing into part 2 dose expansion cohorts to assess JNJ-6372 monotherapy activity in multiple NSCLC sub-populations with genomic alterations.
Janssen Research & Development oncology global therapeutic area head Dr Peter Lebowitz said: “JNJ-6372 is a novel bispecific antibody that we believe has the potential to benefit patients with Exon 20 mutation insertions who often do not respond to currently available oral EGFR-targeted or immune checkpoint inhibitor therapies.
“This Breakthrough Therapy Designation is a significant milestone in our ongoing efforts to advance JNJ-6372 in clinical development and target genetically-defined lung cancer.”
In October 2019, Bayer and Janssen received approval from the FDA for Xarelto (rivaroxaban) to prevent blood clots in acutely ill medical patients.
The approval has been granted for Xarelto to prevent venous thromboembolism (VTE) or blood clots in hospitalised acutely ill medical patients at risk for thromboembolic complications who are not at high risk of bleeding.