The Janssen Pharmaceutical Companies of Johnson & Johnson have been granted Breakthrough Therapy Designation by the FDA for JNJ-61186372 (JNJ-6372) to treat metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR), whose disease has progressed on or after platinum-based chemotherapy.

JNJ-6372 is an EGFR-mesenchymal epithelial transition factor (MET) bispecific antibody that targets activating and resistant EGFR and MET mutations and amplifications. Currently, there are no FDA-approved targeted therapies for patients with lung cancer who have EGFR Exon 20 insertion mutations. The current standard of care for this patient population is conventional cytotoxic chemotherapy.

“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,” said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. “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.”

The Breakthrough Therapy Designation is supported by data from a Phase I study evaluating the safety, pharmacokinetics and preliminary efficacy of JNJ-6372 in advanced NSCLC.
A U.S. FDA Breakthrough Therapy Designation is granted to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition. The criteria for the designation requires preliminary clinical evidence that demonstrates the drug may have substantial improvement over available therapy.