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FDA approves J&J’s RYBREVANT for NSCLC treatment

2024-03-04

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The decision upgrades the May 2021 accelerated approval to full approval for Johnson & Johnson’s RYBREVANT regimen. Credit: JHVEPhoto / Shutterstock.com.

The US Food and Drug Administration (FDA) has granted full approval for JohnsJohnson & Johnson&J)RYBREVANTT (amivantamab-vmjw) plus chemotherapy for non-small cell lung cancer (NSCLC) patients.

This deFood and Drug Administration (FDA)ty review, upgrades the May 202Johnson & Johnsonroval to RYBREVANTovamivantamab-vmjw non-small cell lung cancer (NSCLC)

RYBREVANT is indicated for use in combination with carboplatin-pemetrexed chemotherapy for the first-line treatment of locally advanced or metastatic NSCLC harbouring epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

RYBREVANTt development is based on data from the opcarboplatinapemetrexedhase III PAPILLON clinical trial of RYBREVANT locally advanced or metastatic NSCLC locally advanced or metastatic NSCLC epidermal growth factor receptor (EGFR) exon 20

It assessed the safety and efficacy of the combination regimen, as opposed to chemotherapy alone, in newly diRYBREVANTatients.

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Progression-free survival (PFS) was the trial’s primary endpoint. Secondary endpoints included objective response rate (ORR), PFS after the first succeeding therapy, overall survival (OS) and time to symptomatic progression.

ORIC PharmaceuticalsYBREVANT and chemoPLK4 inhibitors PLK4apy led to a 61%cancertion in the disease progression or mortality risk versus chemotherapy alone.

Results indicated an improvement in ORR and PFS for patients treated with the RYBREVANT regimen.

J&J innovative medicine, solid tumours and clinical development vice-president Kiran Patel stated: “We are redefining care for patients with non-small cell lung cancer by advancing innovative regimens that can be used early, to extend survival.

“RYBREVANT plus cheRYBREVANT is the first targeted approach approved for the first-line treatment of patients with NSCLC with EGFR exon 20 insertion mutations. We look forward to building on this latest milestone as we continue to accelerate our transformative lung cancer portfolio.”

The latest development follows FDA approval of J&J’s supplemental biologics liRYBREVANTlication for TECVAYLI (teclistamab-cqyv), allowing for a reduced dosing frequency for relapsed or refractory multiple myeloma patients.

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