July 22, 2018 – The American Food and Drug Administration (FDA) just approved Ivosidenib (Tibsovo) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation in the IDH1 gene.  It is …

Ivosidenib (Tibsovo) for AML-patients with IDH1-mutations Read more »

January 13, 2018 – The American Food and Drug Administration (FDA) has just approved the first treatment for breast cancer with a certain inherited genetic mutation. At first glance, this announcement may be just one in the series of announcements by the …

Olaparib Tablets (Lynparza): For breast cancer with BRCA gene mutation Read more »

December 25, 2017 – The American Food & Drug Administration (FDA) has approved two genetic tests to identify genetic alterations in tumors.  The FoundationOne CDx (F1CDx) genomic test and the MSK-IMPACT Tumor Profiling test both can help to guide physicians in …

FDA-cleared genomic profiling tests to guide cancer treatment Read more »

August 02, 2017 – This is another cornerstone in the fight against acute myeloid leukemia (AML): The American Food and Drug Administration (FDA) just approved Enasidenib (Idhifa) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia …

Enasidenib (Idhifa): Targeted treatment for relapsed or refractory AML Read more »

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 »

June 16, 2017 – Patient education in pharmacogenetics, the central component of theragenomic and personalized medicine and individualized drug safety is an important issue. Not only needs the individual patient to understand what pharmacogenetics, or more precisely, pharmacogenetic testing can …

Development of a patient education video about pharmacogenetics Read more »

February 01, 2017 – This is an announcement by the American Food & Drug Administration (FDA) who announced on December 19, 2016, that it granted accelerated approval to Rucaparib (Rubraca) to treat women with a certain type of ovarian cancer. …

Genetic outfit at work: Rucaparib (Rubraca) for ovarian cancer with deleterious BRCA mutation(s) Read more »

July 9, 2016 – This is a huge step into the future of theragenomic and personalized medicine and individualized drug safety. In support of the President’s Precision Medicine Initiative (PMI), the American Food & Drug Administration (FDA) just issued two …

Precision Medicine Initiative: draft guidances issued Read more »

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 »