FDA Setback for Roche and Immunogen Breast Cancer Treatment

rocheThe world's biggest cancer-drugs maker Roche (RHHBY) was dealt another setback Friday. The U.S. Food and Drug Administration rejected Roche's request for accelerated approval of its trastuzumab-DM1 (T-DM1) license application. T-DM1 is a potential breast cancer treatment.

The FDA said the T-DM1 trials did not meet the standard for accelerated approval because all available treatment choices approved for metastatic breast cancer had not been exhausted in the study population.

The Swiss company said it will continue with its ongoing Phase III trial and will submit the data from the amended study to support a global regulatory submission in mid-2012. The study compares T-DM1 to lapatinib (GlaxoSmitKline's Tykerb) in combination with capecitabine (Roche's Xeloda) in people with advanced HER2-positive breast cancer whose disease has worsened after receiving initial treatment. HER2-positive breast cancer is characterized by increased quantities of the HER2 protein on the surface of the tumor cells and affects approximately 20% to 25% of patients.

High Revenue Hopes for T-DMI

T-DM1 is what's called an armed antibody as it attaches trastuzumab (Roche's Herceptin) to the chemotherapy DM1. Trastuzumab's job is to bind to the HER2-positive cancer cells and is believed to block out-of-control signals that make the cancer grow while also calling on the body's immune system to attack the cells. Once T-DM1 is absorbed into those cancer cells, it is designed to destroy them by releasing DM1. Roche's Genentech licenses technology for T-DM1 under an agreement with ImmunoGen (IMGN).

Roche submitted the application in July. A mid-stage study showed T-DMI shrank tumors in 33% of women with advanced HER2-positive breast cancer that had worsened following treatment with an average of seven prior medicines for metastatic disease.

Back then, Roche said T-DMI could bring in annual sales of roughly $2 billion and billed the application as a major milestone, according to Reuters. The FDA's cautionary tone would be disappointing for Roche and cause investors more concerns about the company's pipeline of drugs.

Other Setbacks

Creating biosimilars (generic forms of biologic drugs) to Roche blockbusters that would lose patent protection in the next five years is difficult. T-DMI was to replace Roche's Herceptin. But this is not the company's first setback. The FDA is looking at yanking its Avastin drug for breast cancer, and Britain again refused to approve Avastin for colorectal cancer on the basis of its low cost-effectiveness.

Roche stock has lost over 20% of its value so far this year. In premarket trading, Roche stock fell 0.5%. ImmunoGen shares sank some 23%.

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Celine

The FDA is all about money. They don't give a **** about your health at all.

August 28 2010 at 4:03 AM Report abuse rate up rate down Reply
kaykells

Many of these drugs are to prolong life perhaps 3-8 months. That is not to say that those months are spent well, they are just spent alive. The Herceptin, also known as Trastuzumab, can cost upwards of 14k per treatment. The whole industry of drugs and drug makers is a fast moving train taking advantage of people in dire situations with the botton line being dollars. Every patient who takes drugs like this become part of the mice tracking...giving ammo to either the drug company or the FDA to yank any pre-approvals. The real answers lie in catching cancer as early as possible, living a life to avoid carcinogens whenever possible, and learning that death if not a punishment, it is due us all. People with strong genetic links should know their family history and then practice high alert surveillance practices.

August 28 2010 at 1:05 AM Report abuse rate up rate down Reply
Zingeroo

Chemotherapy, radiation, drugs - there must be better ways to rid our bodies of cancer. Problem is pharmacy companies and doctors who speak publicly are in lock step - for instance Dr. Dean Edell - they are a bunch of close minded individuals. Some of the cancer patients themselves are to blame for their unwaivering support of all of their ghastly treatments which they feel are keeping them alive. They are victims of the whole moving train called "cancer treatment". Cancer is big business, let's face it.

August 28 2010 at 12:42 AM Report abuse rate up rate down Reply
adavis1527

Yanking a drug that works because it is not "cost effective" sounds like 'death panels doesn't it. If the reason was that it did not work I could understand this but because it is not cost effective NOW seems premature if the cost of production could reduce the cost of the drug, doesn't it? Wait until "O" care kicks in if you don't think this is right

August 27 2010 at 11:49 PM Report abuse +2 rate up rate down Reply
1 reply to adavis1527's comment
kaykells

adavus1527 - you know absolutely nothing about this. Cost is everything with medicine. If costs are not contained, what do you think happens? I will tell you what happens - no one can afford care any more. These drug companies are some of the biggest rip off artists in the world. When one cancer patients costs 500k to prolong life a short while, everyone should be thinking about outcomes. The outcomes for a lot of breast cancer patients who need this drug is simple - death now or death in a little while. Death before you dump half a million to the drug, hosp and doctors, or death after you spend that money and suffer like a dog while doing it. None of it is pretty, but if there was no money in it, no one would be doing it.

August 28 2010 at 1:10 AM Report abuse rate up rate down Reply
Bug

Oh this is so much crap. They don't want a cure for cancer...they would lose a fortune. Come On Peeps...get real about this stuff.

August 27 2010 at 9:46 PM Report abuse +3 rate up rate down Reply
deniseincaeyes

I have been treating cancer patients since 1980. I have gone form offering nothing to patients and less than 3 months to live to an extra 2 years with some of the high tech biologicals that are specifically targeted for gene therapy. Any one who walks in the shoes knows that 2 years versus 3 months is a lifetime ticking by very slowly when you are faced with death.Of course the pharma have to make money because it costs billions to try and make something test it and do trials, but why would you want the government to control if it might work or not?When it's your life and not theirs an extra few monthe is a lifetime. I can count on 2 hands in 30 years people that were actually at peace with a few months. 30-90 year ols all want extra time.

August 27 2010 at 8:41 PM Report abuse +4 rate up rate down Reply
Kathleen

Bottom line.. the pharmaceutical company didn't grease the palms of the FDA enough! The Medical Cancer machine is killing people not saving lives. The cure rate for cancer 50 years ago was 3 to 5% it is the same today. Any alternative medicine cures that HAVE BEEN PROVEN TO CURE CANCER have been systematically maligned and vilified by the FDA, AMA & the Pharmaceutical companies, including invasion into homes and confiscating effective cures. Cancer research and new medications are a cash cow so why would they ever actually find a cure when they can keep perpetuating the disease and pocketing more money? If you want the truth about cancer cures and how to prevent cancer read Cancer Step Outside the Box www.cancertruth.com you can also check out Cancertutor.com I had cancer but I don't anymore thanks to this book and the information in it.

August 27 2010 at 8:14 PM Report abuse +5 rate up rate down Reply
ladyinbl23

I am a cancer patient, and after surgery. And a year and a half of DR. Dr. Dr.'s, I am going with alternative. I am going to get my immune system in ace shape. That is the way to go. FDA should look into giving the people the choice and insure them for alternative options. We pay enough for insurance.

August 27 2010 at 8:06 PM Report abuse +3 rate up rate down Reply
thepetermedic

omg they try to kill us with the food, but it should be someones right to take this if they want to GO FEDS LOOK LIKE YOUR DOING YOUR JOB LOL

August 27 2010 at 7:10 PM Report abuse +3 rate up rate down Reply
moemonyy

FDA wants a treatment, not a cure. its all about money, always was and always well be.

August 27 2010 at 6:49 PM Report abuse +7 rate up rate down Reply