J&J’s Rybrevant goes subcutaneous in Europe

Johnson & Johnson’s subcutaneous Rybrevant was knocked back by the FDA last December on manufacturing issues, but the EU regulator didn’t have similar qualms. The European commission on Monday greenlit the subcutaneous version as monotherapy in post-platinum NSCLC with EGFR exon 20 insertions, and alongside Lazcluze in first-line EGFRm NSCLC. Approval was based on the Paloma-3 trial in relapsed EGFRm NSCLC, which found similar response rates between IV and SC Rybrevant, and trends towards survival improvements with the SC version. As for the FDA, J&J’s US solid tumour president, Biljana Naumovic, recently told ApexOnco that SC Rybrevant had been resubmitted, but declined to provide a timeline for approval. On Monday the EU also approved another subcutaneous J&J formulation, of the Genmab-partnered Darzalex, for a new use: alongside Velcade, Revlimid and dexamethasone for first-line multiple myeloma, regardless of transplant eligibility. This was based on the Cepheus trial; Darzalex is also awaiting an FDA decision here, although again the timings are unclear, with J&J merely disclosing a US filing in September. One controversy might come from the fact that Cepheus’s primary endpoint was minimal residual disease rather than a more standard survival outcome; the EU green light could provide reassurance.