Pharmalot... Pharmalittle... Good Morning

Interesting! In reference to "Roche Herceptin Studies Offer A Mixed Bag," aside from the issue of congestive heart failure, past studies have suggested a potentially very serious weakness with Herceptin, the problem with central nervous system (CNS) metastasis.

A study from the same Dana Farber Cancer Institute identified CNS metastases in 34% of the women who received Herceptin-based therapy for metastatic breast carcinoma. CNS disease is defined as one or more brain metastases or leptomeningeal carcinomatous (carcinomatous memingitis).

Ironically, that is the same problem they are having with the T-DM1 trial. Brain mets! Some think that patients on the T-DM1 (trastuzumab emtansine) trial should also be given some straight Herceptin, which they think will cross the blood-brain barrier (BBB) and give a certain amount of protection.

The only way for that to happen is a patient may also have to be subjected to an "intrathecal" injection of T-DM1. Herceptin does not cross the BBB because it is a "large" molecule drug. One thing you can definitely say is the T-DM1 is an investigational agent, or just plain experimental.

Scientists learn from each other and create building blocks of intelligence. To start a substantially greater amount of early research could be wasteful since each start will be independent and not gain from the substantial amount of knowledge resting in each start. The MIT Professor has over-simplified the creative process and left out the need for Examining Boards to decide on the research that might be most useful and review these early projects for synergy and further financing. It goes on and on and it is not that easy to simply throw money into the pot.

Greg, you're not actually criticizing a drug that extends life expectancy for women with third line metastatic breast cancer are you?

http://www.nejm.org/doi/full/10.1056/NEJMoa1209124#t=abstract

In metatstatic cancer, this is as good as it gets. These are very ill patients.

John, the trial found that trastuzumab emtansine (T-DM1) can improve progression-free survival in "some" women with metastatic breast cancer. The final arbiter of clinical approval is overall survival. Median overall survival for patients treated with T-DM1 was not reached. Drug response is not a reliable predictor of overall survival. Median progression-free survival was longer in patients treated with T-DM1 than in those treated with the standard therapy (9.6 vs 6.4 months). The difference reached is statistically significant?

The so-called immunoconjugates or antibody-drug conjugates (ADCs) are unique therapeutics that have become the focus of a plethora of recent and ongoing clinical trials, and for the first time since 2000 when Mylotarg (gemtuzumab ozogamicin) was approved in AML, the FDA gave the green light for another ADC, namely Adcetris (brentuximab vedotin) for the management of Hodgkins Lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL), like its sister agent in HER2-positive breast cancer, T-DM1, and other ADCs.

The ADCs do not work for all patients, T-DM1 is meant to treat only roughly 20 percent of breast cancer cases characterized by an abundance of that protein, and they are not totally free of side effects. And of course, T-DM1 is also likely to be very expensive, costing more than $100,000 for a typical course of treatment. One note: Mylotarg was removed from the market in 2010 after newer studies showed it did not prolong lives and had safety problems. At initial approval, Mylotarg was associated with a serious liver condition called veno-occlusive disease, which can be fatal.