Rybrevant Archives - Medical Design Sourcing

Janssen (NYSE:JNJ) has received European authorisation for Rybrevant (amivantamab-vmjw) to treat adults with non-small cell lung cancer (NSCL) with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

Rybrevant is a fully-human EGFR-MET bispecific antibody.

NSCL is responsible for the majority of lung cancers.

The Conditional Marketing Authorisation (CMA) covers patients who have failed platinum-based chemotherapy.

Amivantamab is the first treatment to win approval in the EU specific to EGFR exon 20 insertion mutations for NSCLC. “Patients with NSCLC harboring EGFR exon 20 insertion mutations represent a specific population who have been underserved by current treatment options that are limited in both number and efficacy,” said Dr. Antonio Passaro, Medical Oncologist at the Division of Thoracic Oncology of the European Institute of Oncology, in a press release.

Clinical trials for amivantamab are underway for sol…

Rybrevant, a novel fully-human bispecific antibody from the Janssen division of Johnson & Johnson, became the first treatment for people with non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 20 insertion mutations. In particular, the indication covers such cancer that has progressed on or after platinum-based chemotherapy.

The agency also approved the Guardant360 CDx from Guardant Health as a companion diagnostic for Rybrevant.

“Advances in precision oncology continue to facilitate drug development, allowing diseases like lung cancer to be subset into biomarker-defined populations appropriate for targeted therapies,” said Dr. Julia Beaver, chief of medical oncology in the FDA’s Oncology Center of Excellence, in a statement. “With today’s approval, for the first time, patients with non-small cell lung cancer with EGFR exon 20 insertion mutations will have a targeted treatment option.”

[Related: 25 promising pipeline drugs]<…

Rybrevant

Janssen EMEA gets conditional marketing authorisation for Rybrevant in NSCLC patients

FDA approves Janssen’s Rybrevant for subset of non-small cell lung cancer