Johnson & Johnson's (JNJ) Janssen-Cilag International said Monday it received European Commission approval for its subcutaneous formulation of Rybrevant, or amivantamab, in two indications.
The subcutaneous formulation was approved in combination with lazertinib as the first-line treatment for advanced EGFR-mutated non-small cell lung cancer, and as a monotherapy for patients with EGFR exon 20 insertion mutations after platinum-based therapy failure, the company said.
The company said subcutaneous amivantamab was formulated using Halozyme Therapeutics' (HALO) drug delivery technology.
Johnson & Johnson said the approval follows positive results from a phase 3 study, which achieved its primary endpoints and indicated that subcutaneous amivantamab was "non-inferior" to the intravenous formulation in terms of efficacy and pharmacokinetics.
Johnson & Johnson shares were down nearly 3% in recent Monday trading, while Halozyme stock was up more than 2%.
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