FDA Grants Breakthrough Therapy Designation to JNJ-6372 in mNSCLC

Published on March 10, 2020


The FDA granted Breakthrough Therapy designation to JNJ-61186372 (JNJ-6372) for the treatment of patients with Metastatic Non-Small Cell Lung Cancer, NSCLC, with EGFR exon 20 insertion mutation whose disease has progressed on or after platinum-based chemotherapy.

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 chemotherapy.

JNJ-61186372 (JNJ-6372) is an EGFR MET bispecific antibody.

What is FDA Breakthrough Therapy Designation?

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 Breakthrough Therapy Designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.

JNJ-61186372 Breakthrough Therapy designation is supported by results from a phase I, first-in-human study of JNJ-61186372 (NCT02609776), administered at different doses to evaluate the safety, pharmacokinetics and preliminary efficacy of the agent as monotherapy and in combination with novel irreversible, third-generation, mutant-selective, EGFR TKI tyrosine kinase inhibitor, called Lazertinib in adults with advanced NSCLC.

JNJ-61186372 is intended to treat patients who often do not respond to currently available oral EGFR-targeted or immune checkpoint inhibitor therapies.


The best treatment for a cancer patient is to get the most advanced cancer drugs in advanced stages of development. There, the hope and the chance to extend life go far beyond the standard protocols.

Phase I studies also pose a tremendous opportunity to cancer patients.

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About Non Small Cell Lung Cancer, NSCLC

Lung cancer develops in the lungs for many years. It is a leading cause in death by cancer in the US, Western countries.

The lungs are a double respiratory organ with a sponge-like texture and shaped like a cone in the chest. The lungs provide the body with oxygen and remove carbon dioxide from the body in the process of breathing.

For most patients with stage 4 metastatic lung cancer, current treatments are insufficiently effective. This gives rise to the need for innovative strategies with greater efficacy in fighting the disease.  The National Cancer Institute, NCI, highlights the fact that for a certain group of lung cancer patients, the best treatment option is to join one of the many clinical trials existing worldwide aiming to increase their chances of therapeutic success.

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