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FDA approves Rybrevant and Lumakras for NSCLC

July 2021—The FDA in May approved two new targeted therapies for non-small cell lung cancer.

One is Rybrevant (amivantamab-vmjw) for adult patients with NSCLC whose tumors have EGFR exon 20 insertion mutations. The other is Luma­kras (sotorasib) for adult patients with NSCLC whose tumors have the KRAS G12C mutation and who have received at least one prior systemic therapy.

For Rybrevant, the FDA also approved Guardant Health’s Guardant360 CDx as a companion diagnostic. For Lumakras, it approved the Qiagen Therascreen KRAS RGQ PCR kit and the Guardant360 CDx as companion diagnostics.

Researchers evaluated Rybrevant’s efficacy in a study of 81 patients with NSCLC and EGFR exon 20 insertion mutations whose disease had progressed on or after chemotherapy. The overall response rate was 40 percent. The median duration of response was 11.1 months, with 63 percent of patients having a duration of response of six months or more.

The efficacy of Lumakras was evaluated in 124 patients with locally advanced or metastatic KRAS G12C-mutated NSCLC with disease progression after immune checkpoint inhibitor or chemotherapy or both. The objective response rate was 36 percent, and 58 percent of those patients had a duration of response of six months or longer.

CAP issues blue-top tube recommendations

The CAP on June 15 issued recommendations to guide laboratories in reducing the clinical impact of the shortage of 3.2 percent sodium citrate blue-top tubes, which is expected to persist until the end of this year.

One option is to validate or develop alternative sodium citrate tubes, but laboratories that do so must have a written procedure for this process, document training for it, and follow checklist requirement GEN.40942 (specimen container analytic interference) to ensure the change does not affect patient results.