J&J’s Subcutaneous Rybrevant Receives CHMP Backing for Lung Cancer Treatment Despite Recent FDA Rejection

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval for Johnson & Johnson's subcutaneous formulation of Rybrevant (amivantamab) for treating advanced EGFR-mutated non-small cell lung cancer (NSCLC)14.

This CHMP recommendation comes less than two months after the U.S. Food and Drug Administration (FDA) rejected the subcutaneous formulation due to manufacturing facility issues23.

The CHMP recommendation is based on positive data from the Phase III PALOMA-3 study, which showed that subcutaneous Rybrevant was non-inferior to the intravenous formulation47.

The subcutaneous formulation significantly reduces administration time from hours to minutes and lowers the rate of infusion-related reactions compared to the intravenous version7.

The CHMP has recommended Rybrevant for two indications:
as a first-line treatment in combination with Lazcluze for advanced NSCLC with specific EGFR mutations, and as a monotherapy for advanced NSCLC with EGFR exon 20 insertion mutations after failure of platinum-based therapy7.

Johnson & Johnson is working closely with the FDA to resolve the manufacturing issues and bring the subcutaneous formulation to U.S. patients as quickly as possible2.

Sources:

1. https://endpts.com/jjs-rybrevant-gets-chmp-backing-weeks-after-fda-rejection/

2. https://www.biospace.com/fda/j-js-fda-bid-for-subcutaneous-rybrevant-falls-short

3. https://endpts.com/fda-rejects-jjs-subcutaneous-rybrevant-over-manufacturing-issues/

4. https://www.nasdaq.com/articles/chmp-gives-nod-expanded-use-jjs-rybrevant-azns-imfinzi

7. https://pmlive.com/pharma_news/jjs-subcutaneous-rybrevant-receives-positive-chmp-opinion-for-advanced-lung-cancer/