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I have been a patient of Dr. White for about three years. I find him very knowledgeable and professional. I just had a skin cancer removed by sur...

Jul 26, 2011

FDA Approves New Melanoma Drugs

is the deadliest and most serious form of skin cancer.
If it is recognized and treated early, it is almost always curable, but if it is not, the cancer can advance and spread to other parts of the body, where it becomes hard to treat and can be fatal. 

Three new drugs have been approved for the treatment of inoperable or advanced metastatic (spreading) melanoma:

  • Ipilimumab (pronounced ip-ee-LIM-yoo-mab)
  • Peginterferon alfa-2b
  • Vemurafenib (pronounced vem-yoo-RAF-en-ib)

Information courtesy of the American Academy of Dermatology:

Do these drugs cure melanoma?
No. These drugs do, however, offer patients who respond more time. Here is what researchers found during clinical trials:

  • Ipilimumab: The patients who received only ipilimumab and responded to it lived about 10 months longer. For a few patients given ipilimumab, the response was dramatic. A few patients have had no signs of cancer for as long as 6 years.
  • Peginterferon alfa-2b: The patients who responded to this drug stayed in remission (no signs of cancer) for 9 months longer than patients who did not receive the drug.
  • Vemurafenib: On average, patients who responded lived 6.2 months without the melanoma getting worse.

Who can take these drugs?
These drugs may be an option for some patients with advanced melanoma:

  • Ipilimumab: Approved for patients ages 18 and older who have melanoma that is in stage III or stage IV and cannot be removed with surgery.
  • Peginterferon alfa-2b: Approved for patients aged 18 and older who have stage III melanoma. Patients take this drug after undergoing surgery to remove lymph nodes that contain cancer. The drug should be started within 84 days of surgery.
  • Vemurafenib: Patients who are eligible for vemurafenib have metastatic melanoma and have been diagnosed with a BRAF V600 mutation.

While the FDA established these guidelines, this does not mean that a drug is the right choice for every patient who fits one of the above descriptions. Your oncologist, doctor who specializes in cancer treatment, or your dermatologist will consider many factors before prescribing one of these drugs.

What do these drugs do?
Each drug works a bit differently:

  • Ipilimumab: Blocks a specific molecule, which may allow the patient’s body to recognize, target, and attack melanoma cells.
  • Peginterferon alfa-2b: Helps the body to find and destroy stray melanoma cells not removed during surgery, which may delay the melanoma from returning.
  • Vemurafenib: Targets the BRAF mutation, which may stop the cancer cells from continuing to grow uncontrollably and the cancer from getting worse.

Note: About half of the patients diagnosed with late-stage melanoma have a mutation in a gene known as BRAF. This mutation causes their cells to grow uncontrollably and cancer to form.

How many patients respond to the drugs?
One of the drawbacks is that not every patient responds, as the following data shows:

  • Ipilimumab: In the clinical trials, only 10.9% responded to the drug.
  • Peginterferon alfa-2b: In the clinical trial, one group of patients received this drug after surgery to remove the lymph nodes. The other group did not receive any additional treatment. There was not a significant difference in remission (no signs of cancer) between these two groups. At 4 years, 45.6% of patients who received the drug had no signs of cancer and 38.9% of patients who had no additional treatment had no signs of cancer.
  • Vemurafenib: At the end of 6 months, 84% of the patients who received this drug were alive. Other patients in the clinical trial received chemotherapy, and 64% of these patients were alive at the end of 6 months.

What is the benefit of taking one of these drugs?
Two of these drugs, ipilimumab and vemurafenib, give patients who respond a few more time. For a few patients given ipilimumab, the response was dramatic. A few patients have had no signs of cancer for as long as 6 years.

Peginterferon can prevent the melanoma from spreading beyond the lymph nodes.

How do patients take these drugs?

  • Ipilimumab: A healthcare provider gives this drug through an IV line. Each infusion takes about 90 minutes. The standard dose is 4 infusions, with an infusion given once every 3 weeks. The dose can vary from patient to patient.
  • Peginterferon alfa-2b: A patient injects this drug under the skin (subcutaneous injection). Before a patient receives this drug, a nurse or other healthcare provider shows the patient how to prepare and measure the medicine and how to inject it.
  • Vemurafenib: In clinical trials, patients are taking a pill twice a day.

What are the side effects?
All medicines have potential side effects. Before taking any medicine, you should talk with your doctor about the side effects. If you decide to take one of these medicines, you will receive a guide that describes the possible side effects.

Research continues
For the first time, patients with advanced melanoma have treatment that may prolong their life. One drug is giving patients longer remissions. These successes are fueling further research. New drugs are already undergoing clinical trials.

Please remember to ALWAYS check your moles and remember your ABCDE's of Melanoma. If you have ANY question or concern about any of your moles, be sure to call us right away. It could save your life! Call us at 803.329.6030 or book an appointment online for your (at least) yearly mole check.

If you are interested in learning more about skin cancer treatments, skin cancer surgery, medical dermatology or cosmetic dermatology in the Rock Hill, South Carolina, and Charlotte, North Carolina metro area, click here to request an appointment with Dr. Timothy Woodall, Dr. Richard White, or Ms. Kristin Berka. Or you can call our office, The Palmetto Skin & Laser Center, at (803) 329-6030 to schedule your appointment.