Johnson & Johnson submits application to FDA for non-small cell lung cancer drug

USA- Johnson & Johnson has submitted a biologics license application (BLA) to the US FDA for a fixed combination of amivantamab and recombinant human hyaluronidase for subcutaneous administration in patients with non-small cell lung cancer (NSCLC).

It is for all currently approved or submitted indications of intravenous (IV) Rybrevant (amivantamab-vmjw) in patients with non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutations.

The BLA submission is based on the results from the open-label, randomized Phase III PALOMA-3 clinical trial, which compared the pharmacokinetics, efficacy, and safety of SC amivantamab combined with lazertinib to its intravenous counterpart in advanced or metastatic NSCLC patients. 

The trial enrolled 418 patients with EGFR-mutated advanced or metastatic NSCLC after progression on osimertinib and chemotherapy.

The study found that SC amivantamab had comparable overall response rates to IV administration in patients with NSCLC harbouring EGFR exon 19 deletion or L858R mutations. 

Additionally, SC amivantamab demonstrated significantly shorter administration time and a five-fold reduction in infusion-related reactions, alongside longer overall survival, progression-free survival, and duration of response.

Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Johnson & Johnson Innovative Medicine, stated, “Rybrevant administered intravenously is a foundational treatment for patients with EGFR-mutated NSCLC. 

‘’This subcutaneous option, administered in approximately five minutes, is a clinically important advancement that could transform the treatment experience for patients, oncologists and nursing staff.

‘’We look forward to working with the FDA and global regulators in the review of these applications.”

The submission follows the recent FDA approval of the intravenous RYBREVANT in combination with chemotherapy for first-line treatment of NSCLC with EGFR exon 20 insertion mutations, based on the Phase III PAPILLON study. 

The Committee for Medicinal Products for Human Use (CHMP) in Europe provided a positive opinion for RYBREVANT plus chemotherapy for the same indication.

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