June 30, 2017 – The below citation from PubMed addresses an vey important issue associated with genetic testing in theragenomic and personalized medicine. It is the question if the genetic test used to stage, classify, or determine treatability of a …

The Clinical and Economic Impact of Inaccurate EGFR Mutation Tests in the Treatment of Metastatic Non-Small Cell Lung Cancer Read more »

Tagged with: , , , , , , , ,

June 03, 2016 – This is a huge step in the application of theragenomic medicine in cancer patients in the quest to deliver highly individualized health care for patients. Thus, on June 01, the American Food & Drug Administration (FDA) approved the …

This is it: First blood test to detect EGFR gene mutations in NSCLC Read more »

Tagged with: , , , , , , , , , , ,

March 14, 2015 – The American Food and Drug Administration (FDA) just approved Crizotinib (Xalkori) to treat the patient subpopulation with advanced (metastatic) non-small cell lung cancer (NSCLC) whose tumors have an ROS-1 gene alteration. Crizotinib (Xalkori) is the first …

The use of Crizotinib (Xalkori) has been expanded to treat advanced NSCLC in the patient group who carries a ROS-1 gene alteration Read more »

Tagged with: , , , , , ,

February 07, 2016 – The European Commission has approved once-daily Osimertinib (Tagrissa) for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) that is positive for the epidermal growth-factor receptor (EGFR) T790M mutation. This follows a positive review in …

Osimertinib (Tagrissa) approved for non-smal cell lung cancer (NSCLC) patient subgroup carrying the EGFR T790M mutation Read more »

Tagged with: , , , , , , ,

December 12, 2015 – The American Food and Drug Administration today approved Alectinib (Alecensa) to treat people with advanced (metastatic) ALK-positive non-small cell lung cancer (NSCLC) whose disease has worsened after, or who could not tolerate treatment with, another therapy called …

Alectinib (Alecensa) approved for treatment of patients with advanced (metastatic) ALK-positive non-small cell lung cancer (NSCLC) Read more »

Tagged with: , , , , , ,

November 14, 2015 – The American Food and Drug Administration (FDA) just granted accelerated approval for an oral medication to treat patients with advanced non-small cell lung cancer (NSCLC). Osimertinib (Tagrisso) was approved for patients whose tumors have a specific …

Theragenomic medicine: FDA approves Osimertinib (Tagrisso) to treat patients with non-small cell lung cancer (NSCLC) who carry the EGFR mutation T790M Read more »

Tagged with: , , , , , , ,

Immune Checkpoint Regulation: The role of the PD-1/PDL1 pathway.

October 11, 2015 – In recent months, Nivolumab (Opdivo), a human IgG4 anti-PD-1 monoclonal antibody which targets the PD-1 receptor, had been approved first for the treatment of unresectable  or advanced (metastatic) melanoma and secondly for the treatment of advanced (metastatic) squamous non-small cell …

Nivolumab (Opdivo) demonstrates survival benefit in squamous and non-squamous non-small cell lung cancer (NSCLC) Read more »

Tagged with: , , , , , , , , , , ,

October 06, 2015 –  Lung cancer is the leading cause of cancer death in the United States, with an estimated 221,200 new diagnoses and 158,040 deaths in 2015, according to the National Cancer Institute. Among lung cancers, non-small cell lung …

Remarkable: Pembrolizumab (Keytruda) now also for advanced non-small cell lung cancer (NSCLC) Read more »

Tagged with: , , , , , , , , ,

May 14, 2013 – The US Food and Drug Administration (FDA) today announced the approval of the cobas EGFR Mutation Test, a companion diagnostic for the cancer drug Erlotinib (Tarceva). This is the first FDA-approved companion diagnostic that can detect …

FDA Approves Companion Genetic Diagnostic Test for Erlotinib [Tarceva] in NSCLC Read more »

Tagged with: , , , , , , , , , ,