New skin cancer drug approved
January 31st, 2012
09:18 AM ET

New skin cancer drug approved

Adults with metastatic basal cell cancer now have a new drug to help them battle the disease.

The Food and Drug Administration has approved Erivedge under the agency's priority review program. The program provides an expedited six-month review process for drugs that may result in major treatment advances.

Erivedge is for patients with advanced basal cell carcinoma  who are not candidates for radiation or surgery, or for those whose cancer has spread. BCC is the most common form of skin cancer in the country. It grows slowly and is generally curable.

The new drug inhibits a molecular pathway called the Hedgehog pathway, which is found in most basal cell cancers.

"Our understanding of molecular pathways involved in cancer, such as the Hedgehog pathway, has enabled the development of targeted drugs for specific diseases," said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "This approach is becoming more common and will potentially allow cancer drugs to be developed more quickly. This is important for patients who will have access to more effective therapies with potentially fewer side effects."

This is the first FDA-approved treatment for metastatic BCC. It comes in pill form - a capsule that's taken once a day.

According to the drug's manufacturer, Genentech, an independent review of clinical studies found Erivedge shrank lesions in 43% of patients with locally advanced BCC and 30% in patients with metastatic BCC.

"Today's approval provides a new treatment for people with advanced basal cell carcinoma who, until now, had no approved medicines to help shrink disfiguring or potentially life-threatening lesions," said Dr. Hal Barron, chief medical officer and head, Global Product Development for Genentech.

Dr. Evan Lipson, and instructor of medical oncology at Johns Hopkins Kimmel Cancer Center has treated patients with the drug.

"Like most of the pathway therapy drugs that we are using these days, these drugs are remarkably successful compared to the chemotherapy drugs that have been available to us up until now," Lipson said. "The downside is that the effects of the drug on the tumor are not as long lasting as we would like and research is underway to develop ways to create longer lasting responses."

There are side effects , including muscle spasms, hair loss, weight loss, distorted sense of or loss of taste. Erivedge will come with a black box warning about the potential risk of death, and of severe birth defects to unborn babies. Pregnancy status must be verified before starting treatment.

According to Genentech, the drug will be available within two weeks.

soundoff (2,438 Responses)
  1. Furious Styles

    Whew, those side effects sound like pretty nasty stuff.

    January 31, 2012 at 10:23 | Report abuse | Reply
    • fred

      Not quite as bad as the side affects of the skin cancer. My father died of skin cancer and I wish they had some treatment like this 15 years ago.

      January 31, 2012 at 10:57 | Report abuse |
    • Chillin

      Yeah, medical marijuana doesn't have side effects like that, and has been shown to fight cancer. Marijunana oil extract has been shown to destroy cancerous skin lesions when used as a topical ointment.

      January 31, 2012 at 11:05 | Report abuse |
    • Furious Styles

      @Fred, sorry to hear that.@Chillin does marijuana fight all types of cancers or is it more effective on some more than others?

      January 31, 2012 at 12:34 | Report abuse |
    • BillRubin

      Chillin, saying "medical marijuana has been shown to fight cancer" overgeneralizes it's efficacy. Yes, there is anecdotal evidence that topical marijuana extract treats non-metastatic Basal Cell Carcinoma. This is an area of research that shows significant promise and will likely be accepted into conventional medical practice if it's proven effective compared to the current available topical treatments. But you're not addressing the type of cancer, prognosis, staging, recurrence risk etc. Very misleading.

      January 31, 2012 at 15:46 | Report abuse |
    • Chartreuxe

      This is for basal cell carcinoma, Fred. It can be horribly disfiguring but does not usually does prove deadly unless it metastasizes to a major organ. It's usually melanoma that proves deadly.

      I am truly sorry for your loss.

      February 1, 2012 at 10:18 | Report abuse |
  2. Mahhn

    The side effect "death" as listed cures all cancers. Hell you don't need a perscription to get that cure, or money.

    January 31, 2012 at 10:31 | Report abuse | Reply
    • Brandy

      When you have cancer, you are willing to do anything. Until you have gone thru it, you have no idea of how important this is. The key word is potential and this is on all meds one takes. Its worth it to take the chance, the oncologist and your doc monitors your every side effect. You receive scans that monitor your heart. Its worth it.

      January 31, 2012 at 10:38 | Report abuse |
    • Pumbaa

      I wonder if the drug actually increases the life span of the cancer patient?

      January 31, 2012 at 11:06 | Report abuse |
    • Chartreuxe

      If death were your only choice you would not consider it a cure. I have survived 3 different cancer diagnoses.

      Perhaps you should not speak of something of which you have so little experience.

      February 1, 2012 at 10:22 | Report abuse |
  3. Brandy

    This is wonderful, you could lose your hair but as a breast cancer survivor hair lost is minimal. With most cancer drugs you lose your hair, lost of taste for a while, some get sick but with the anti nausea meds they give you its not like it was years ago. This drug will be worth it to millions who have this disease. Genetech does it again, if it wasnt for them herceptin wouldnt be available for breast cancer victims with HER2 protein.

    January 31, 2012 at 10:33 | Report abuse | Reply
  4. Smock

    "Comment waiting for approval" is a joke/lie/deception. Posters shouldn't lose everything they write because of one word, left or right. This needs to be fixed. Nothing ever gets approved once it's in "Approval land". It should go to an edit page and alert you to what caused it to be rejected. Spending 5 mins writing something, for anyone, only to have it lost is just a complete waste of time. I'd love to see the editors delete everything a CNN reporter writes because they don't agree with one thing. Fix it, reject it when people try to post it and let them correct the PC offense.

    January 31, 2012 at 10:58 | Report abuse | Reply
  5. L

    A picture of a sunbather on a skin cancer article? Where is your editor?

    January 31, 2012 at 10:59 | Report abuse | Reply
    • Cannabis science fan cbis

      Marijuana is a safe alternative cure for the same problem, check out stock ticker CBIS. I was amazed.

      January 31, 2012 at 11:02 | Report abuse |
    • Hear Ye

      I believe you fail to understand the purpose of the photo.

      January 31, 2012 at 11:07 | Report abuse |
    • BillRubin

      "Marijuana is a safe alternative cure for the same problem, check out stock ticker CBIS. I was amazed."

      This is false and very misleading. We're talking about METASTATIC basal cell carcinoma.

      January 31, 2012 at 15:49 | Report abuse |
    • Chartreuxe

      Marijuana does *not* cure cancer. It can be used to treat nausea due to chemotherapy.

      The sunbather image is meant to illustrate the fact that skin cancer sometimes comes from sunbathing.

      February 1, 2012 at 10:27 | Report abuse |
  6. clint

    THIS is not a cure, people. Shrinking a rapidly growing tumor by 30pct is not removing it. This is a last ditch "something" for those that failed other treatments that were to give a promise of a cure. Buying time if that. Just realistic.

    January 31, 2012 at 11:32 | Report abuse | Reply
  7. nightsun

    THC oil has been around for years and works quite well on skin cancer, side effects include.....well, none unless you actually injest the oil and then the worst side effect is wanting to order a pizza...oh, and injesting it also helps with other types of cancers and a massive host of others issues...watched my mother-in-law come back from stage 4 lung cancer after they gave her 4 months to live, don't care if you believe me or not....saw it with my own two eyes....also know of a girl who is alive and well after being on the edge with ovarion cancer....oh ya, in case you're wondering, no i don't smoke it so that's not why i think it should be legalized, helping people and or saving lives....sounds like a good enough reason to me

    January 31, 2012 at 11:35 | Report abuse | Reply
    • Cannabis science fan cbis

      cannibisscience.com There are 3 cases listed and the company (CBIS) is now filing for FDA approval to use this product across the country. I agree nightsun! It does need to be legalized, total cashcrop, job creator, and recession buster... All without making smoking it legal.

      January 31, 2012 at 12:22 | Report abuse |
  8. r

    And what is the price of each pill? In this country probably $100. Elsewhere, say in Europe, probably $10.

    January 31, 2012 at 11:53 | Report abuse | Reply
    • Chartreuxe

      How is that *your* business? Do you suffer from basil cell carcinoma?

      I do.

      All medications are more expensive until the research costs are repaid. When the patent expires it becomes generic and the price drops dramatically. If you're unaware of how the marketing of drugs work, perhaps you should educate yourself in the matter.

      February 1, 2012 at 10:31 | Report abuse |
    • Thatiana

      Drug Abuse Clinics Dot Net is looking faorrwd to hearing comments and opinions from our visitors. Feel free to leave comments on topic but we will not accept spam.

      April 8, 2012 at 11:37 | Report abuse |
  9. Carla Vazq

    What the drug companies don't want you to know. Research this on your own. Scientific Name...

    Annona muricata

    Google "annona muricata cancer"

    Read the studies and read why the FDA and pharma companies keep it a secret. Fact...the pharma companies can not patent the chemicals in the plant. And if they can not patent the chemical they can not make money.

    Also, the drug companies put millions of dollars into "chanca piedra". They found that they could not patent the chemicals. However, Lilly is spending millions on plant research which include "chanca piedra".

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    January 31, 2012 at 12:28 | Report abuse | Reply
    • Steve C.

      My mother has breast cancer. She lives in Denver. She was was given Graviola by the hospital. She was told to drink it 3X each day.

      When she began drinking Graviola tea they gave her 4 to 6 months to live. Now they have given her an additional 6 months.

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      January 31, 2012 at 12:43 | Report abuse |
    • bobh

      Alternative medications are taking over and the drug companies and FDA don't like it.

      This is the way it works. If the drug company can not patent a drug they will not send it to the FDA for approval. That is the simple explanation!

      The "D" in FDA means "Drug". The FDA will not put much time into an "alternative medication" unless it is submitted as a "drug" for approval. Ask them about this.

      If a phama company finds a chemical in a plant that is "water soluble" they limit their research because it is extremely difficult to patent a water soluble chemical. What this means is, if the chemical in the drug is water soluble you can put the plant in water and boil it or saturate it and you will extract the chemical into the water. Then you can drink the water and consume the chemical! Pretty simple chemistry.

      Some chemicals such as THC are very different and that is why the drug companies continue to research marijuana. To extract THC from pot you must use oil (butter works fine) or a gas (as in making hash).

      Eli LIlly has invested tens of millions on THC (along with other companies and the Federal Government). Research this one on your own and be surprised!

      Something else to think about concerning pot. If THC is so bad, why does the Veterans Administration allow their shrinks to discuss it with PTSD patients? Google that one!

      When the drug companies discover a way to patent THC along with another chemical (as a single drug) do you think they will release that information before the patent term runs out?

      January 31, 2012 at 13:14 | Report abuse |
    • OrtegaM

      Naive to think that a cure for a disease can not be extracted from a plant. To many people don't realize what most chemicals are developed from....duh PLANTS!

      Also, something that doctors don't tell you in the USA or limit the discussion. "Baking Soda". Look that up on google!

      In many countries it is illegal to purchase large amounts of baking soda without a prescription. Only because baking soda is used in the manufacture of illegal drugs.

      For instance. In Ecuador get caught with 10 lbs of baking soda! Have your attorneys phone number available and expect to spend the afternoon in jail. You better know a doctor or a patient with cancer.

      January 31, 2012 at 13:26 | Report abuse |
    • BillRubin

      I google'd it and found this...

      Annona Muricata demonstrated anticancer effects in vitro, but HAS NOT BEEN STUDIED IN HUMANS. Despite the LACK OF HUMAN DATA, many websites promote Annona Muricata to cancer patients based on traditional use and on the in vitro studies. Caution is required as there is NO EVIDENCE OF EFFICACY.

      Source: 1: Oncology (Williston Park). 2008 Sep;22(10):1202
      Cassileth B. Memorial Sloan-Kettering Cancer Center, New York, New York, USA.

      January 31, 2012 at 18:06 | Report abuse |
    • Heidi

      Chanca Piedra (Phyllanthus niruri) is one of the most important superherbs yet discovered in the entire history of herbalism due to its effect on directly fighting calcium-forming organisms (microscopic coral-like organisms that are currently termed nanobacteria). Nanobacteria have been linked to inflammation and the production of bad calcium in the human body. Nearly every disease condition known to humans, mammals, reptiles, and birds involves calcification (the overproduction of bad calcium due to the growth of nanobacteria). Chanca Piedras name means stone breaker due to its ability to break up calcium phosphate crystals (bad calcium). This superherbs historical use in achieving excellent gall bladder and kidney health is sizeable and well studied. In South America, this superherb is also known for many other properties including helping: malaria symptoms, fever, flu, alleviating liver stagnation, improving digestion, and even as a mild laxative and pain reliever.

      February 1, 2012 at 12:35 | Report abuse |
  10. BobD

    Ask Pfizer Inc how much they spent in 2011 on THC research for cancer patients. Or just ask the right corporate pilot for the company!

    January 31, 2012 at 13:32 | Report abuse | Reply
  11. Danny

    Make the Graviola tea put it into a misting spray bottle and spray it on your skin after a sunburn! Spray it onto your skin if you have spots related to prolonged sun exposure...just don't tell the FDA you did.

    January 31, 2012 at 13:42 | Report abuse | Reply
  12. GBfromOhio

    I always recommend that folks work with their doctor and oncologist of course, but in terms of some natural supplements that MAY be of some value and I'll just toss out there, do some research on Astaxanthin (by Cyanotech, the synthetic forms are useless) and also AHCC ((Active Hexose Correlated Compound).

    January 31, 2012 at 14:20 | Report abuse | Reply
  13. RoadRunner, Albuquerque, NM

    I recall in the 1960's when then Pres. Nixon declared "war on cancer." Oh, people were so pumped. Money poured into cancer research, as hopes soared that this scourge would be conquered. Now, more than a generation later, what do we have to show for it? A pill that sometimes shrinks an otherwise curable form of skin cancer, but has a side effect of causing death? WOW! I mean WOW! Are our scientist just that dumb that they can't find a cure for cancer in over a generation with full scale, all out war declared on this scourge? Or do we just need to give up, adjust our sights, and know that cancer will always be with us like poverty, and fat-cat bankers?

    January 31, 2012 at 17:13 | Report abuse | Reply
    • BillRubin

      To imply that there is little to show for it is an insult to the thousands of scientists and professionals that dedicate their lives finding a cure. There are cures quite a few cancers, including several leukemias and lymphomas, which are curable with chemotherapy and radiation, and solid tumors like testicular, anal, breast and colorectal cancer which are curable with a combination of surgery, chemotherapy, and radiation. We do fairly well against EARLY stage cancer, we don’t do so well against stage IV metastatic disease. Cancer is not a single disease, it comprises hundreds of diseases with very complex and different pathophysiologies.

      January 31, 2012 at 17:51 | Report abuse |
    • Tiffany

      There's lots of types of chemo and it can be administered in nrefeifdt ways. Chemotherapy literally means drug therapy' and isn't actually a brand of drug in itself. It can be used to treat Cancer or auto-immune diseases like Lupus.Side effects vary depending on what chemo you are having and the person involved. Sometimes people lose hair, are sick, are just tired, or aren't affected at all.

      April 7, 2012 at 21:35 | Report abuse |
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    My son was on a clinical trial for this drug for medulloblastoma, an aggressive pediatric brain tumor. While he had great early results, his cancer developed an immunity to the drug. Nonetheless, we remain highly optimistic that this is an important step in moving towards highly targeted cancer therapy that focuses on a particular characteristic of the cancer (in this case, the cellular communications pathways). Much thanks to the dedicated cancer researchers.

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    SWEET!!! Back to the tanning bed.

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  16. Renait

    Why is there no story about the recall of one of the most widely-prescribed birth control pills in the US? NO STORY. At. All.

    February 1, 2012 at 09:05 | Report abuse | Reply
    • BillRubin

      Yes there is, look again.

      February 1, 2012 at 11:50 | Report abuse |
  17. Theresa

    I was told "it is an easy cancer", I had a tiny dot, had Mohs surgery and 16 inch scar on my face,I work and it is desfiguring, not to mention that in 6 months I had 6 biospsies.
    I am not a natural blond, do not tan,spend time in the outdoors. I had breast cancer in the past with a masectomy and chemo, but Basal Cell Carcinoma has left me in shock, depressed and scared.
    It is serious if it is on the scalp, and one cant see it, or inside ears , because can damage not only tissue, but muscles and bone.Patients loose eyelids, ears,etc.
    I do not have any cancer of any kind in my family .

    February 1, 2012 at 14:04 | Report abuse | Reply
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    Astaxanthin has been discussed by Dr. Mehmet Oz and Dr. Joe Mercola and recommended by many health experts, including myself. I take 12 milligrams every morning. I'd like to clarify one myth now: Krill supplements contain trace amounts of astaxanthin, not nearly what you need to achieve the therapeutic benefits discussed today. Here are five reasons to take astaxanthin supplements every day:,..^;

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Get a behind-the-scenes look at the latest stories from CNN Chief Medical Correspondent, Dr. Sanjay Gupta, Senior Medical Correspondent Elizabeth Cohen and the CNN Medical Unit producers. They'll share news and views on health and medical trends - info that will help you take better care of yourself and the people you love.