Janssen’s BLA for amivantamab marks the first regulatory submission for the treatment of EGFR exon 20 insertion mutation-positive NSCLC
Janssen seeks FDA approval for amivantamab. (Credit: Vberger/Wikipedia.)
Johnson & Johnson’s pharmaceutical business Janssen has filed a Biologics License Application (BLA) with the US Food and Drug Administration (FDA) for the approval amivantamab to treat patients with a type of non-small cell lung cancer (NSCLC).
Janssen’s BLA seeks FDA approval of amivantamab for the treatment of epidermal growth factor receptor (EGFR) exon 20 insertion mutation-positive metastatic NSCLC patients, whose disease progressed with platinum-based chemotherapy.
The company said that its BLA for amivantamab is the first regulatory submission for the treatment of NSCLC with EGFR exon 20 insertion mutations.
Also, the firm has established an expanded access program (EAP) to provide eligible US patients with enhanced access to amivantamab during review period.
Janssen Research & Development global oncology therapeutic area head Peter Lebowitz said: “This submission marks an important step forward in our drive toward evolving the treatment landscape for patients with NSCLC who have EGFR exon 20 insertion mutations and for whom there are no FDA-approved targeted treatment options.
“We are committed to the development of therapies like amivantamab that progress precision medicine and target specific pathways, and to providing access through expanded access programs.”
Amivantamab is an investigational, fully-human EGFR and mesenchymal epithelial transition factor (MET) bispecific antibody, with immune cell-directing activity that targets tumours with activating and resistance EGFR and MET mutations and amplifications.
The drug has been granted Breakthrough Therapy Designation from the US FDA for the same indication, in March 2020.
The company stated that its BLA for amivantamab is based on data from the monotherapy arm of the Phase 1 CHRYSALIS study, a multi-centre, open-label, multi-cohort study.
Phase 1 CHRYSALIS study evaluated the safety and efficacy of amivantamab both, as a monotherapy and in combination with lazertinib, a novel third-generation EGFR tyrosine kinase inhibitor (TKI), in patients with advanced NSCLC.
The study investigators evaluated the efficacy using overall response rate per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), clinical benefit rate, and duration of response and progression-free survival, along with amivantamab safety profile.
Janssen Research & Development global head Mathai Mammen said: “Lung cancer remains the leading cause of cancer deaths worldwide. Given this significant unmet need, we at Johnson & Johnson are committed to improving outcomes for patients diagnosed with this complex, deadly disease.
“With today’s submission for amivantamab, we are one step closer to that goal. We are steadfast in our focus to advance novel therapeutics and medicines that will transform the trajectory of some of the most challenging and deadly diseases of our time, including lung cancer.”