FDA grants accelerated approval for Janssen’s lung cancer drug
pharmafile | May 24, 2021 | News story | Sales and Marketing |
The FDA have granted accelerated approval of Rybrevant (amivantamab-vmjw) 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.
Rybrevant is the first fully-human, bispecific antibody approved for the treatment of patients with NSCLC that targets EGFR exon 20 insertion mutations, which are the third most prevalent activating EGFR mutation.
Mathai Mammen, Global Head of Janssen Research & Development, Johnson & Johnson, said: “The approval of rybrevant, the first lung cancer treatment for Johnson & Johnson, strengthens our commitment to harness science, expertise, and scale to dramatically alter the trajectory of lung cancer, and reduce the impact of the world’s leading cause of cancer mortality.”
The approval of Rybrevant follows the FDA’s decision to grant Breakthrough Therapy Designation (BTD) in March 2020 and the initiation of a Priority Review of the Biologics License Application (BLA) in December 2020.
The FDA approval is based upon positive results from the Phase I CHRYSALIS study, a multicentre, open-label, clinical study evaluating rybrevant as a monotherapy in patients enrolled in the prior platinum containing chemotherapy cohort.
Lung cancer is the leading cause of cancer death among both men and women, accounting for almost 25% of all cancer deaths. Currently available targeted treatments, like EGFR tyrosine kinase inhibitors, are generally insensitive in treating NSCLC driven by EGFR exon 20 insertion mutations, and are not FDA-approved for these patients.
NSCLC driven by this mutation carries a worse prognosis and shorter survival rates compared with lung cancer driven by more common EGFR mutations, such as exon 19 deletions and L858R substitutions. Rybrevant works by binding extracellularly (outside of the cell) inhibiting tumour growth and leading to tumour cell death.
Joshua K. Sabari, MD, from the New York University Langone’s Perlmutter Cancer Center, said: “Lung cancer is a complex disease, and through the study and deeper understanding of genetic alterations like EGFR exon 20 insertion mutations, we are able to target the disease in new ways and improve treatment outcomes for patients.
“Amivantamab-vmjw is an innovative bispecific antibody that brings an important new therapeutic approach to physicians caring for patients with this serious and rare type of lung cancer.”
Kat Jenkins
