Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for JNJ-6372 for the Treatment of Non-Small Cell Lung Cancer

RARITAN, NJ, March 10, 2020 – The Janssen Pharmaceutical Companies of Johnson &Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for JNJ-61186372 (JNJ-6372) for the treatment of 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. JNJ-6372 is an EGFR-mesenchymal epithelial transition factor (MET) bispecific antibody that targets activating and resistant EGFR and MET mutations and amplifications.[1] Currently, there are no FDA-approved targeted therapies for patients with lung cancer who have EGFR Exon 20 insertion mutations.[2]Patients with NSCLC and EGFR Exon 20 insertion mutations have a form of disease that is generally insensitive to EGFR tyrosine kinase inhibitor (TKI) treatments and carries a worse prognosis compared to patients with more common EGFR mutations (Exon 19 deletions/L858R substitution).[3] The current standard of care for this patient population is conventional cytotoxic chemotherapy.[4] “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, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research &Devel...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news

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