The US Food and Drug Administration (FDA) has granted full approval for Johnson & Johnson's (J&J) RYBREVANT (amivantamab-vmjw) plus chemotherapy for non-small cell lung cancer (NSCLC) patients.
This decision, which comes after a priority review, upgrades the May 2021 accelerated approval to full approval.
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.
The latest development is based on data from the open-label, randomised Phase III PAPILLON clinical trial of RYBREVANT in combination with chemotherapy.
It assessed the safety and efficacy of the combination regimen, as opposed to chemotherapy alone, in newly diagnosed patients.
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.
The combination of RYBREVANT and chemotherapy led to a 61% reduction 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 chemotherapy 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 licence application for TECVAYLI (teclistamab-cqyv), allowing for a reduced dosing frequency for relapsed or refractory multiple myeloma patients.
