Rybrevant Receives Accelerated Approval to Treat Lung Cancer

Rybrevant Receives Accelerated Approval to Treat Lung Cancer

May 21, 2021 – The U.S. FDA has granted accelerated approval for RybrevantTM (amivantamab-vmjw), manufactured by Janssen, to treat adults who have locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

NSCLC accounts for 80-85% of all lung cancers, and 2-3% of NSCLC patients have EGFR exon 20 insertion mutations. These mutations cause rapid cell growth, which contributes to rapid cancer spread. Rybrevant is the first FDA-approved targeted therapy for NSCLC with EGFR exon 20 insertion mutations. It is an antibody that binds itself to the outside of the cell, causing the cell to die and inhibiting the tumor’s ability to grow.

In a clinical trial, Rybrevant delivered an overall response rate of 40% and a median duration of response of 11.1 months. Of patients who responded to treatment, 63% experienced a duration of response lasting six months or more.

Recommended dosing is 1,050mg for patients who have a baseline weight of less than 80kg (176 pounds) and 1,400mg for patients whose baseline weight is 80kg or more. Rybrevant is administered weekly for four weeks, with the initial dose given as a split intravenous infusion in Week 1 on Day 1 and Day 2, then once every two weeks until disease progression or unacceptable toxicity occur.

Rybrevant has launched at a wholesale acquisition cost (WAC) of $2,986.43 per 350mg vial.