FDA Grants Breakthrough Therapy Designation to J&J’s Lung Cancer Therapy

March 11, 2020

The decision comes after results were received from a Phase 1, open-label study that evaluated the safety, pharmacokinetics, and preliminary efficacy of the monotherapy

The Janssen Pharmaceutical Companies of Johnson & Johnson announced on March 10, 2020 that FDA granted breakthrough therapy designation to JNJ-61186372 (JNJ-6372), a bispecific antibody for patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy.

According to a company press release, the decision comes after results were received from a Phase 1, open-label study that evaluated the safety, pharmacokinetics, and preliminary efficacy of the monotherapy in combination with lazertinibi, a novel third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), in adult patients with advanced NSCLC.

"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, MD, PhD, Global Therapeutic Area head, Oncology, Janssen Research & Development, in the press release. "This [b]reakthrough [t]herapy [d]esignation is a significant milestone in our ongoing efforts to advance JNJ-6372 in clinical development and target genetically-defined lung cancer."

Source: Janssen