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 ‘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.

Go deeper with GlobalData

  • ReportsLogo

  • ReportsLogo

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

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鈥檚 primary endpoint. Secondary endpoints included objective response rate (ORR), PFS after the first succeeding therapy, overall survival (OS) and time to symptomatic progression.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile 鈥� free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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: 鈥淲e are redefining care for patients with non-small cell lung cancer by advancing innovative regimens that can be used early, to extend survival.

鈥淩YBREVANT 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.鈥�

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