FDA grants breakthrough therapy designation to new immunotherapy drug

Posted January 11, 2021

The FDA has granted a breakthrough therapy designation to a promising new immunotherapy drug called tiragolumab that can be used in combination with atezolizumab (Tecentriq) as a first-line therapy for metastatic non-small cell lung cancer (NSCLC) patients with high PD-L1 expression. NSCLC patients must not have the EGFR or ALK genomic tumor irregularities present.

This breakthrough therapy designation will accelerate the progress of the CITYSCAPE clinical trial to focus event more on the benefits of tiragolumab as a possible chemotherapy-free combination treatment in earlier stages of cancer.

Read more here.


FDA approves Tagrisso as first adjuvant therapy for earlier stage NSCLC with certain EGFR mutations

Posted January 4, 2021

On December 18, 2020 the FDA approved Osimertinib (Tagrisso) as the first adjuvant therapy that can be used in NSCLC Stage IB-IIIA patients positive for either EGFR exon 19 or exon 21 L858R genetic mutations. Patients must first have undergone resection, or in other words had their tumor removed with surgery,  before receiving Tagrisso.

The most exciting part about this approval is that Tagrisso can now be used to treat NSCLC patients in earlier stages as well as late stage. This provides the potential for an earlier and hopefully more curative therapy, which is great news for the nearly 20% of all lung cancer patients who have the EGFR mutation.

Read more here.


FDA grants sotorasib breakthrough therapy designation

Posted December 9, 2020

As of December 8, 2020, the FDA has granted a breakthrough therapy designation for a drug called sotorasib for the treatment of patients living with non-small cell lung cancer (NSCLC) containing the KRAS G12C mutation. This treatment may be used on NSCLC patients after they are confirmed to have the KRAS G12C mutation through the use of an FDA-approved diagnostic test and following at least one other systemic therapy.

The KRAS genetic mutation is the most commonly occurring mutation in adenocarcinoma NSCLC. Furthermore, the KRAS G12C mutation affects roughly 13% of all adenocarcinoma NSCLC patients. In the United States alone, 25,000 NSCLC patients will be diagnosed with this specific mutation every year.

This breakthrough therapy designation for sotorasib brings the lung cancer community closer to finding the very first targeted therapy that can be used to treat this commonly occurring genetic mutation.

Read more here.


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.