FDA knocks back subcutaneous Rybrevant

Johnson & Johnson previously made much of receiving priority review for the subcutaneous version of its anti-EGFR x cMet bispecific Rybrevant, but ultimately this hasn’t helped speed its path to market. The FDA on Monday issued a complete response letter for the project; J&J said this was due to issues at a manufacturing facility picked up during a pre-approval inspection, and not related to the formulation, efficacy or safety. The company added that no further studies were needed. J&J didn’t disclose when it planned to resubmit subcutaneous Rybrevant, which in the pivotal Paloma-3 trial showed not only equivalence to intravenous Rybrevant but also a trend towards improvements in progression-free and overall survival. J&J isn’t the only company to get tripped up by manufacturing issues lately, with Regeneron’s BCMA-targeting T-cell engager linvoseltamab, and Merck’s HER3 ADC patritumab deruxtecan receiving similar knockbacks. These events look sloppy rather than fatal, but J&J needs SC Rybrevant to bolster sales of the franchise. Rybrevant is approved for the niche of EGFR-mutated non-small cell lung cancer, but the company thinks it will eventually become a $5bn drug. J&J doesn’t yet split out the product’s revenues, but plans to start doing so next year.