March 11, 2020
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FDA grants breakthrough therapy designation to JNJ-6372 for lung cancer subset

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The FDA granted breakthrough therapy designation to JNJ-6372 for the treatment of certain patients with metastatic non-small cell lung cancer, according to the agent’s manufacturer.

The designation applies to use of the agent for patients with epidermal growth factor receptor exon 20 insertion mutations whose disease progressed on or after platinum-based chemotherapy.

JNJ-6372 (Janssen) is a dual-targeting EGFR-mesenchymal epithelial transition (MET) factor bispecific antibody. The agent targets activating and resistant EGFR and MET mutations and amplifications.

There are no FDA-approved targeted therapies for patients with lung cancer who have EGFR exon 20 insertion mutations. Standard treatment for these patients 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,” Peter Lebowitz, MD, PhD, global therapeutic area head for oncology at Janssen Research & Development, said in a company-issued press release.

The FDA based the breakthrough therapy designation in part on data from a phase 1 study designed to evaluate JNJ-6372 as monotherapy and in combination with lazertinib (Janssen/Yuhan Corp.) — a novel third-generation EGFR tyrosine kinase inhibitor — for adults with advanced NSCLC.

“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,” Lebowitz said in the release.