CHMP recommends SC Rybrevant for EGFR-mutated NSCLC patients

Positive opinion issued for marketing authorisation extension

The Committee for Medicinal Products for Human Use (CHMP) has recommended extending marketing authorisation for a subcutaneous (SC) formulation of Rybrevant for treating non-small cell lung cancer (NSCLC).

The Janssen-Cilag International NV announcement stated: “The SC formulation of amivantamab offers an improved treatment experience, reducing administration time from hours to minutes and substantially lowering rates of infusion-related reactions”.

CHMP’s recommendation follows phase 3 PALOMA-3 study results, showing non-inferiority to the intravenous (IV) administration, meeting both co-primary PK endpoints. The study also reported fewer venous thromboembolic events.

SC amivantamab, in combination with LAZCLUZE, is recommended for adult patients with advanced NSCLC with epidermal growth factor receptor (EGFR) mutations. The recommended dosing is weekly from Weeks 1 to 4 and every two weeks starting at Week 5.

Silvia Novello, M.D., Ph.D., Professor of Medical Oncology at San Luigi Hospital, University of Turin, stated: “This positive CHMP opinion is a welcome milestone in the treatment of EGFR-mutated NSCLC”.

The PALOMA-3 study demonstrated non-inferiority of SC amivantamab compared to IV administration. At a median follow-up of 7 months, the overall response rate was 30% for SC arm and 33% for IV.

Administration time for SC amivantamab was reduced to around five minutes compared to five hours for IV, with a five-fold reduction in infusion-related reactions.

Henar Hevia, PhD., Senior Director, EMEA Therapeutic Area Lead, Oncology, Johnson & Johnson Innovative Medicine, said: “The positive CHMP recommendation for subcutaneous amivantamab takes us one step closer to making this a reality”.

The overall safety profile of SC amivantamab was consistent with IV administration, with common adverse events including paronychia, hypoalbuminemia and rash.