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 »

July 13, 2015 – This post persents a press announcement by the U.S. Food and Drug Administration (FDA).  The text has slightly been edited by the autor of this blog. Thus, FDA today approved Gefinitib (Iressa) for the first-line treatment …

Theragenomic Medicine: Gefinitib (Iressa) targeted therapy for first-line treatment of patients with a type of metastatic lung cancer approved Read more »

October 10, 2013 – Very recently, David Kerr, Professor of Cancer Medicine at University of Oxford, in the United Kingdom, and past President of the European Society for Medical Oncology, talked on Medscape (see the video here) about risk-benefit analyses …

Can We Identify Risk for Drug Toxicity? Read more »

July 18, 2013 – The U.S. Food and Drug Administration (FDA) very recently approved Gilotrif (afatinib) for patients with late stage (metastatic) non-small cell lung cancer (NSCLC) whose tumors express specific types of epidermal growth factor receptor (EGFR) gene mutations, …

FDA approves new treatment for a type of late-stage lung cancer. Companion test also approved to identify appropriate patients Read more »

May 30, 2013 – From a Medscape News Release we learn today that two new drugs have been approved by the US Food and Drug Administration (FDA) for use in certain patients with metastatic or unresectable melanoma, along with a …

Dabrafenib [Tafinalar] and Trametinib [Mekinist] Approved for BRAF V600 Mutated Metastatic Melanoma Read more »

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 »

August 26, 2011 – Today, the  American Food and Drug Administration (FDA) has approved Crizotinib [Xalkori] to treat the patient subgroup with late-stage (locally advanced or metastatic), non-small cell lung cancers (NSCLC) whos cancers express (i.e., test positive for the …

FDA Approves Crizotinib [Xalkori] with Companion Diagnostic Test for Non-Small Cell Lung Cancers (NSCLC) Positive for the Anaplastic Lymphoma Kinase (ALK) Gene Read more »

August 17, 2011 — The US Food and Drug Administration (FDA) has just approved the oral targeted therapy Vemurafenib [Zelboraf] for the first-line treatment of both metastatic and unresectable melanomas. The drug is specifically indicated for patients with melanoma whose …

Vemurafenib [Zelboraf] Approved Together with a Companion Diagnostic Test by FDA for Advanced Melanoma in BRAF V600E Positive Patients Read more »

April 23, 2011 – In the history of flawed and/or market-withdrawn drugs, Lumiracoxib [Joicela], formely known as [Prexige], may only be a footnote, hardly comparable to the attention received by the high flying but ill-fated Rofecoxib [Vioxx], Troglitazone [Rezulin], and …

Could a biomarker rescue Lumiracoxib [Joicela], formerly known as [Prexige]? A genome-wide study identifies a strong assossiation of the HLA allele DQA1*0102 with Lumiracoxib [Joicela]-related serious liver injury Read more »