FDA approves cobas EGFR mutation test v2

Posted November 5, 2020

The Food and Drug Administration approved “cobas EGFR mutation test v2” to identify NSCLC patients eligible for any of the EGFR inhibitor therapies, including those used to treat EGFR exon 19 and L858R deletions, as well as any EGFR therapies to come in the future. 

Read more here.


FDA grants priority review to Libtayo®

Posted November 2, 2020

The Food and Drug Administration granted priority review to cemiplimab-rwlc (Libtayo®) for treatment of certain patients with non-small cell lung cancer.

The designation applies to use as first-line therapy for locally advanced or metastatic NSCLC with 50% or greater PD-L1 expression.

Read more here.


FDA approves diagnostic test for NTRK+

Posted October 27, 2020

On October 23, the Food and Drug Administration approved the next-generation sequencing (NGS)-based FoundationOne CDx test as a companion diagnostic to help identify NTRK+ solid tumor patients eligible for larotrectinib.

Read more here.


FDA grants expedited review for Tagrisso® in early-stage lung cancer

Posted October 21, 2020

The Food and Drug Administration has granted its Priority Review designation for AstraZeneca’s Tagrisso® in certain patients with early-stage lung cancer.

These faster reviews, which take six months instead of the standard 10-month timeframe, are reserved for medicines that demonstrate significant improvements in efficacy or safety for serious diseases.

Read more here.


FDA approves drug for patients with NSCLC RET mutation

Posted September 8, 2020

On September 4, the Food and Drug Administration granted accelerated approval of Gavreto™ (pralsetinib) for people with metastatic non-small-cell lung cancer (NSCLC) with the RET mutation.

Gavreto™ inhibits a receptor tyrosine kinase known as RET, which plays a role in cell proliferation. RET gene mutations or fusions can drive cancer growth, and about 1-2% of NSCLC patients are thought to be affected.

This is the second drug approved for patients whose cancers harbor RET mutations. This approval provides oncologists and patients with an additional option for treatment.

Read more here.


FDA grants priority review to tepotinib for NSCLC patients with MET

Posted August 27, 2020

The Food and Drug Administration has given priority review to tepotinib, a soon-to-be targeted therapy for NSCLC patients with the MET exon 14 mutation.

This new drug will be in addition to Tabrecta™, which was previously approved for MET exon 14.

Read more here.


FDA approves first liquid biopsy with NGS technology for EGFR

Posted August 7, 2020

On August 7, the U.S. Food and Drug Administration approved the Guardant360 CDx assay liquid – or blood – biopsy. This biomarker test uses next-generation sequencing (NGS) technology to identify patients with the epidermal growth factor receptor (EGFR) gene in a deadly form of metastatic non-small cell lung cancer (NSCLC). This is the first approval to combine two technologies — NGS and liquid biopsy — in one diagnostic test in order to guide treatment decisions.

Typically, biomarker testing involves a tissue sample from the primary tumor. This biomarker testing will use blood instead, while still utilizing the NGS biomarker testing normally done on tissue samples. 

Read more here.