Home Alzheimer’s Disease FDA Grants Breakthrough Therapy Designation to JNJ-6372 for NSCLC

FDA Grants Breakthrough Therapy Designation to JNJ-6372 for NSCLC

The FDA granted breakthrough therapy designation to JNJ-61186372 (JNJ-6372) to treat metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 20 insertion mutations, according to a Janssen press release.

The breakthrough therapy designation for JNJ-6372, an EGFR-mesenchymal epithelial transition factor (MET) bispecific antibody, was approved for those whose disease has progressed on or after platinum-based therapy.

“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, Janssen Research & Development, LLC, said in a press release.

Data from the open-label, multicenter phase I trial supported the FDA’s…

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