FDA Grants Breakthrough Therapy Designation to J&J’s Lung Cancer Therapy
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
Texas' MD Anderson Cancer Center Creates New Cell Therapy Institute
November 11th 2024With the launch of the Institute for Cell Therapy Discovery and Innovation, the MD Anderson Cancer Center will bring together expertise in developing cell therapies for cancer, autoimmune diseases, and infections.
