May 30, 2019 – The American Food and Drug Administration (FDA) recently approved Alpelisib (Piqray) to be used in combination with the FDA-approved endocrine therapy fulvestrant, to treat postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor …

The PI3K inhibitor Alpelisib (Piqray) for progressing breast cancer in women (and men) Read more »

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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 »

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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 »

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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 »

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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 »

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  April 30, 2017 – The American Food and Drug Administration (FDA) just approved Midostaurin (Rydapt) for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who carry particular genetic mutations in the FLT3 (CD135) gene, in combination …

LeukoStrat CDx FLT3 Mutation Assay: New entry in the field of companion tests Read more »

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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 »

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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 »

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April 12, 2016 – The American Food and Drug Administration (FDA) just approved Venetoclax (Venclexta) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have a chromosomal abnormality called 17p deletion and who have been treated with a …

Venetoclax (Venclexta) for the treatment of patients with chronic lymphocytic leukemia (CLL) Read more »

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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 »

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