www.fdanews.com/articles/196313-janssen-nabs-breakthrough-therapy-designation-for-lung-cancer-treatment
Janssen Nabs Breakthrough Therapy Designation for Lung Cancer Treatment
March 19, 2020
The FDA granted breakthrough therapy designation to Janssen’s novel antibody JNJ-6372 for treatment of patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor (EGFR) Exon 20 insertion mutations.
The agency granted the designation based on positive results from a phase 1 trial of JNJ-6372 as a monotherapy and in combination with lazertinib.
Janssen entered into a license and collaboration agreement with Yuhan Corporation for the development of lazertinib.