Janssen announced the U.S. Food and Drug Administration (FDA) granted JNJ-6372 Breakthrough Therapy Designation for metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 20 insertion mutations where the disease has progressed while the patient is on or after receiving platinum-based chemotherapy.
Breakthrough Therapy Designation is designed to speed the development and regulatory review of drugs for serious or life-threatening diseases. It is based on preliminary clinical data showing the drug might have substantial improvement on at least one clinically significant endpoint over available therapy.
The Breakthrough Therapy Designation was based on data from a Phase I trial of JNJ-6372 alone and in combination with lazertinib, a novel third-generation EGFR TKI in adults with advanced NSCLC.
Jansen is currently enrolling Part 2 dose expansion cohorts evaluating the drug as a monotherapy in multiple NSCLC sub-populations with specific genetic changes like those with C797S resistance mutation or MET amplification. Lazertinib is a third-generation EGFR inhibitor that Janssen licensed from China’s Yuhan Corp in 2018 for $50 million up front and up to $1.25 billion in possible milestone payments.