On May 21, 2021, The Janssen Pharmaceutical Companies of Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) had granted the accelerated approval of RYBREVANT^TM (amivantamab-vmjw) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. RYBREVANT^TM 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. This approval follows the FDA’s decision to grant Breakthrough Therapy Designation (BTD) in March 2020 and to initiate a Priority Review of the Biologics License Application (BLA) in December 2020. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Lung cancer is the most common cancer type and the leading cause of cancer-related deaths worldwide, with non-small cell lung cancer accounting for 80% to 85% of all lung cancers, according to the American Cancer Society. Approximately 2% to 3% of patients with non-small cell lung cancer will have EGFR exon 20 insertion mutations, which are a group of mutations on a protein that causes rapid cell growth, and consequently, helps cancer spread. EGFR exon 20 insertion mutations are the third most common type of EGFR mutation.

Researchers evaluated Rybrevant’s efficacy in a study of 81 patients with non-small cell lung cancer and EGFR exon 20 insertion mutations whose disease had progressed on or after platinum-based chemotherapy. The main outcome measured was overall response rate (proportion of patients whose tumor is destroyed or reduced by a drug). In the trial population in which all patients received Rybrevant, the overall response rate was 40%. The median duration of response was 11.1 months, with 63% of patients having a duration of response of 6 months or more.

RYBREVANT^TM is a fully-human bispecific antibody directed against EGFR and MET receptors. RYBREVANT^TM binds extracellularly (outside of the cell) inhibiting tumor growth and leading to tumor cell death. Today’s accelerated FDA approval is based on positive results from the Phase 1 CHRYSALIS study, a multicenter, open-label, clinical study evaluating RYBREVANT^TM as a monotherapy in patients enrolled in the prior platinum containing chemotherapy cohort.

The FDA simultaneously approved Guardant Health’s Guardant360^® CDx liquid biopsy blood test as a companion diagnostic for use with RYBREVANT^TM.