Rybrevant approved for some non-small cell lung cancer patients

Rybrevant (amivantamab-vmjw) was approved for adults with non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, the U.S. Food and Drug Administration announced Friday.

The Guardant360 CDx (Guardant Health Inc.) liquid biopsy test was also approved as a companion diagnostic for use with Rybrevant.

The approval of Rybrevant was based on efficacy data from the ongoing Phase 1 CHRYSALIS study, a multicenter, open-label, clinical study of 81 patients with non-small cell lung cancer and EGFR exon 20 insertion mutations whose disease progressed with platinum-based chemotherapy. Depending on weight, patients received a dose of either 1,050 mg or 1,400 mg weekly for four weeks, with an initial dose as a split infusion in week 1 on days 1 and 2 and then administered every two weeks until disease progression or toxicity. Researchers observed a 40 percent response rate with Rybrevant, including 3.7 percent complete responses and 36 percent partial responses. Median response duration was 11.1 months, and 63 percent of patients had a response duration of six months or longer.

The most commonly reported side effects were rash, infusion-related reactions, skin infections around the fingernails or toenails, muscle and joint pain, shortness of breath, nausea, fatigue, swelling in the lower legs or hands or face, sores in the mouth, cough, constipation, vomiting, and changes in certain blood tests. If patients develop symptoms of interstitial lung disease, the FDA notes that Rybrevant should be withheld, and it should be permanently discontinued if interstitial lung disease is confirmed. Patients taking Rybrevant should be advised to limit sun exposure during treatment and for two months following.

Approval of Rybrevant was granted to Janssen Pharmaceutical Companies of Johnson & Johnson.

Tagrisso approved as adjuvant therapy for NSCLC with EGFR mutations

More information:
More Information

Copyright © 2021 HealthDay. All rights reserved.

Rybrevant approved for some non-small cell lung cancer patients (2021, May 26)
retrieved 26 May 2021

This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no
part may be reproduced without the written permission. The content is provided for information purposes only.

Source link

Leave a Reply

Your email address will not be published. Required fields are marked *

Back to top button

Ad Block Detected

Welcome to Mediexpose, Please support our journalism by allowing ads. With support from readers like you, we can continue to deliver the best. You can support us free by simply allowing ads.