▎WuXiEdited by Kant Content Team

Johnson & Johnson today announced that it has submitted a Biologics License Application (BLA) to the U.S. FDA, seeking approval for the fixed combination of its bispecific antibody Rybrevant (amivantamab) with recombinant human hyaluronidase for subcutaneous administration, for all currently approved or pending indications of Rybrevant intravenous formulation to treat certain non-small cell lung cancer (NSCLC) patients.According to the press release, patients are able to complete the injection of this subcutaneous formulation within 5 minutes.

This BLA submission is primarily based on the results of the PALOMA-3 study. The data shows that, in the epidermal growth factor receptor (EGFR) In NSCLC patients with exon 19 deletions or L858R mutations, the subcutaneous formulation of Rybrevant has a similar overall response rate to the intravenous formulation.The subcutaneous formulation of Rybrevant has demonstrated a significantly shortened administration time, a fivefold reduction in infusion-related reactions, along with longer overall survival, progression-free survival, and duration of response.According to the press release, such efficacy results have never been seen in previous studies evaluating intravenous and subcutaneous formulations. Detailed trial results were published this month.Journal of Clinical OncologyThe submission of the BLA also includes data from the Phase 2 trial PALOMA-2, which supports dosing frequencies of every two weeks and every three weeks.

Rybrevant is a humanized EGFR/MET bispecific antibody.It has multiple mechanisms of anticancer action, not only blocking EGFR and MET-mediated signal transduction but also guiding immune cells to target tumors carrying activating and drug-resistant EGFR/MET mutations and amplifications. Rybrevant received approval from the U.S. FDA in May 2021.Accelerated Approval, and received in March this yearFull Approval, used to treat conditions detected by FDA-approved testsEGFRAdult patients with locally advanced or metastatic NSCLC who have exon 20 insertion mutations and whose disease has progressed during or after platinum-based chemotherapy.

References:

[1] Subcutaneous amivantamab Biologics License Application submitted to U.S. FDA for patients with EGFR-mutated non-small cell lung cancer. Retrieved June 17, 2024 from https://www.prnewswire.com/news-releases/subcutaneous-amivantamab-biologics-license-application-submitted-to-us-fda-for-patients-with-egfr-mutated-non-small-cell-lung-cancer-302173613.html

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