After a priority review, the FDA did not approve an injectable form of Rybrevant, a Johnson & Johnson medication for non-small cell lung cancer.
The rejection is not due to the therapy's formulation, safety or efficacy, according to the drugmaker. Instead, the FDA's response "is related to observations as part of a standard pre-approval inspection at a manufacturing facility," J&J said in a Dec. 16 statement.
Rybrevant (amivantamab) is currently approved in an intravenous presentation. The experimental injection drug combines amivantamab and recombinant human hyaluronidase.
J&J said it is working with the FDA to bring the formulation to market.