BRCA Freed from Myriad's Patents, Supreme Court Rules

The Supreme Court in a 9-0 ruling invalidated Myriad's patents on BRCA opening up the field for cheaper testing for the breast cancer risk genes BRCA1 and BRCA2. Myriad was criticized for selling $3000 tests and blocking mon-n-pop University labs to run similar tests at fraction of the cost.

GSK Receives FDA Approval for Melanoma Drugs Dabrafenib and Trametinib

The approval of two new melanoma drugs TAFINLAR^® (dabrafenib) and MEKINIST™ (trametinib) by the FDA this week is timely for melanoma patients whose tumors often develop resistance to other targeted therapies, such as Zelboraf. 

Dabrafenib is indicated for patients with BRAF V600E mutation. Another drug, vemurafenib (aka ZELBORAF) by Genentech which was approved in January 2011 also targets the same protein. BRAF V600E is an always-on signaling protein found in majority of melanomas. (Read more about vemurafenib or BRAF V600E here.)

The second drug, trametinib is the first MEK inhibitor to be approved for melanoma.  Unlike dabrafenib or vemurafenib, this drug's target is downstream of BRAF kinase and, thus trametinib can complement the other two drugs in clinical practice. Both drugs will be available by prescription in Fall 2013.

Antiangiogenic Agent Thalidomide No Good in Mesothelioma

Malignant pleural or peritoneal mesothelioma is invariably fatal cancer with options that are largely supportive in nature. The current first-line chemotherapy regimens including pemetrexed with or without cisplatin or carboplatin do not provide long-term survival. This cancer is highly angiogenic and thus preclinical and early data supported the use of anti-angiogenic agent thalidomide.

However, a recent clinical trial published in this month's issue of the journal Lancet Oncology shows that thalidomide when added to chemotherapy does not provide any additional benefit.  

The Specter of Rising Cancer Deaths in Latin America and Caribbean

Latin America and the Caribbean are the next hotspots of cancer-related deaths in the world and countries in this region are woefully ill-prepared to face this growing epidemic. A report by Latin American Cooperative Oncology Group (LACOG) presented at the LACOG Conference 2013 on April 26-27, 2013, at Sao Paulo, Brazil, put these facts in depressing hard numbers: currently 13 people of 22 diagnosed with cancer die in Latin America and the Caribbean in contrast to 13 of 37 in US or 13 of 30 in Europe. This translates to 59% of cancer patients dying of cancer in Latin America and the Caribbean compared to 35% in US or 43% in EU.

Upcoming meeting: Tumor Models, Boston, July 23-25, 2013

Better Preclinical Models. Better Predictions. Better Patient Response.

Tumor Models gives you the tools to develop and utilize the very best preclinical oncology models. 

This is a meeting for drug developers who are looking for answers to the difficulties faced with preclinical oncology models that are currently being used to test new cancer drugs. This is a forum to learn what you really need to know about the models pharma are using that are superior in predicting efficacy and mimicking tumor activity in patients. It’s also the best way to identify what preclinical questions need to be answered and make the best possible translational decisions. Decisions that will lead to more effective drug performance in the clinic. 

Three Decades of SEER Data Confirms That Mammogram Screening Does More Harm Than Good

Nearly one-third or 1.3 million women over the past 30 years were overdiagnosed with breast cancer (ie, their tumors would have never led to clinical symptoms in their lifetimes) in the United States,  according to the research published in the November 22, 2012 issue of the New England Journal of Medicine. 

Serious Doubts on Biosimilars Ability to Rise Over the Cancer Biologics' Patent Cliffs

The year 2012 saw conversation on the pricing structure and affordability of oncology drugs taking a center stage with commentaries, such as, "The Truly Staggering Cost Of Inventing New Drugs," by Mathew Herper in Forbes pegging the cost of inventing and developing these drugs at $1-$4 Billion, to news about Sloan-Kettering Cancer Center saying "NO" to Zaltrap (Sanofi's drug for colon cancer, then priced at $11,000 per month) for providing a marginal 1.4 month survival benefit. (Sanofi has since cut the price by 50%.) 

What will rein in these Aston Martin-like price tags. At least Herceptin will lose its patent protection soon. Right? And biosimilars will force the price down. Wrong! Those banking on biosimilars to bring the cost down to earth are in for a rude shock.

Unlock the Power of CTCs in the Clinic

Pexa-Vec Doubles Survival of Advanced Hepatocellular Carcinoma Patients

An oncolytic virus-based drug JX-594 (also called Pexa-Vec) is highly effective in patients with advanced hepatocellular carcinoma. According to the results of a Phase II clinical trial published online at Nature Medicine journal's website on February 10, 2013, the patients who were given higher (more effective) dose of JX-594 had a median survival of 14.1 months which was twice that seen in the low dose group (6.7 months).

Upcoming meeting: Tumor Models, London, January 2013

The path to successful clinical development of oncology drugs starts with using predictive tumor models. This is easier said than done. 

The organizers of the Tumor Models meeting in London (January 29-31, 2013) have assembled a roster of speakers from AstraZeneca, Eisai, Roche, MedImmune, Genentech, Sanofi and others to discuss tumor models used at these companies, optimization of traditional models, and explore alternative models and methods to better predict drug efficacy.