Indication and Limitations of use

IMLYGIC® (talimogene laherparepvec) is a prescription medication injected on the skin, beneath the skin, or in your lymph glands to treat a type of skin cancer called melanoma when it can no longer be surgically removed. IMLYGIC® may not help you live longer and may not shrink cancer in your organs (for example, lung or liver).

IMLYGIC® Results

IMLYGIC® takes the fight to advanced melanoma tumors

IMLYGIC® Results
IMLYGIC® Has Proven Results

IMLYGIC® has results that last for 6 months
or longer1

Patients who take IMLYGIC® may experience shrinkage or disappearance of their tumors for 6 continuous months or longer.1-3

Patients who take IMLYGIC® for at least 6 months may see a durable response.

Of 295 patients, 48 (16.3%) had a durable response*
with IMLYGIC® compared
to 3 out of 141 patients (2.1%) in the control group.2

Of the 48 patients who achieved a durable response with IMLYGIC®, 14 patients (29.1%) had a durable complete response. This means that all evidence of tumors disappeared for 6 months or longer.3,4

Of the 48 patients who achieved a durable response with IMLYGIC®, 34 patients (70.8%) had a durable partial response. This means the size of all tumors that could be measured was reduced by 50% or more for 6 months or longer.3,4

Of the 3 patients in the control group who achieved a durable response as described above, all of them had a durable partial response. This means that at least half of all evidence of tumors disappeared for 6 months or longer.3,4

*Unadjusted Relative Risk 7.6 (95%, CI: 2.4, 24.1), P<0.0001.

Tumors may shrink by at least half their size.2,3

Patients who take IMLYGIC® may also see an overall response. This means that tumors
may shrink by at least half their size.2,3

1 in 4 patients (78 out of 295, or 26.4%) saw their tumors shrink by at least half, compared with 1 in 20 (8 out of 141, or 5.7%) in the control group.2

Patients who take IMLYGIC® for at least 6 months may also see an overall response.

†Overall response rate was a secondary endpoint of the study. This means that while the study was not designed to assess overall response, it was still a measurable result in the study. Overall response rate is the percentage of patients that had either a complete response or a partial response.2

On average, patients taking IMLYGIC® could see a response by 4.1 months.1

It was common for patients taking IMLYGIC® to see a response by 4.1 months.

Some people began to respond to treatment as early as 1.2 months, and others as late as 16.7 months.1 It is important for your doctor to monitor your condition regularly to see how your body is responding.

This time to response was another secondary endpoint of the study.2

Existing tumors may increase in size and new tumors could appear during treatment with IMLYGIC®.1

How IMLYGIC® was studied

IMLYGIC® was studied in 436 patients with Stage IIIB/C and Stage IV melanoma against a control group given another treatment called Granulocyte-Macrophage Colony-Stimulating Factor, or GM-CSF.1

IMLYGIC® was injected into tumors, and the control group was given GM-CSF subcutaneously (under the skin).


If you have additional questions about IMLYGIC®,
talk to your doctor and read the Medication Guide.

IMLYGIC® Medication Guide

Talk to your doctor about IMLYGIC®

Things to Ask Your Doctor

  • How is IMLYGIC® different from other cancer medicines?

  • What results might I expect from IMLYGIC® treatment?

  • What are the potential side effects of IMLYGIC®?

    Be sure to review the Important Safety Information with your doctor (see below).

  • Is my immune system strong enough?

    People who have HIV infection or AIDS, blood or bone marrow cancer, autoimmune disease, or other medical conditions that can weaken the immune system should not take IMLYGIC®.

Talking to Your Doctor About IMLYGIC®

Download the IMLYGIC® Patient Brochure as a resource
for useful information about melanoma and IMLYGIC®.


Next: Treatment With IMLYGIC®

IMPORTANT SAFETY INFORMATION

Indication and Limitations of Use

What is IMLYGIC® used for? IMLYGIC® (talimogene laherparepvec) is a prescription medication used to treat a type of skin cancer called melanoma when it is on your skin or in your lymph glands. IMLYGIC® may not help you live longer and may not shrink cancer in your organs (for example, lung or liver).

IMPORTANT SAFETY INFORMATION

What is IMLYGIC® used for?

IMLYGIC® (talimogene laherparepvec) is a prescription medication used to treat a type of skin cancer called melanoma when it is on your skin or in your lymph glands.

IMLYGIC® may not help you live longer and may not shrink cancer in your organs (for example, lung or liver).

What is IMLYGIC® made from and how is it given?

  • IMLYGIC® is a weakened form of Herpes Simplex Virus Type 1, which is commonly called the cold sore virus. Your doctor will inject IMLYGIC® directly into your tumor(s).
  • Your doctor will decide which tumor(s) to inject and may not inject every one. It is important to care for the treatment sites properly so that IMLYGIC® does not spread to other people. Your doctor will show you how to do this.

Who should not take IMLYGIC®?

You should not get IMLYGIC® if you are pregnant or have a weakened immune system (for example, an immune deficiency, blood or bone marrow cancer, steroid use, or HIV/AIDS).

What should you tell your doctor before getting IMLYGIC®?

  • Because certain medications can affect your immune system, or affect how IMLYGIC® works, tell your doctor if you are taking steroids or other medicines that suppress your immune system, or are taking antiviral medications to treat or prevent herpes, like acyclovir.
  • Tell your doctor if you have or ever had certain medical conditions like: HIV infection or AIDS, blood or bone marrow cancer, autoimmune disease, or other medical conditions that can weaken your immune system.
  • Tell your doctor if you have close contact with someone who has a weakened immune system or is pregnant.
  • IMLYGIC® may harm your unborn baby. Tell your doctor if you are pregnant or planning to become pregnant, nursing, or planning to breastfeed. You should not become pregnant during treatment with IMLYGIC®. Your doctor will determine whether you should receive IMLYGIC®. Talk to your doctor about effective birth control methods.
  • Tell your doctor about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. IMLYGIC® may affect the way other medicines work and other medicines may affect how IMLYGIC® works.

The IMLYGIC® virus can spread to other areas of your body or to your close contacts (household members, caregivers, sex partners, or persons sharing the same bed). Do the following to avoid spreading IMLYGIC® to other areas of your body or to your close contacts. You should share this information with them:

  • Avoid direct contact between your treatment sites, dressings, or body fluids and close contacts (for example, use condoms when engaging in sexual activity, avoid kissing close contacts if either of you has an open mouth sore).
  • Don’t touch or scratch the parts of your body that have been injected with IMLYGIC®.
  • Wear gloves while putting on or changing your dressings.
  • Keep treatment sites covered with airtight and watertight dressings for at least 1 week after each treatment (or longer if the treatment site is weeping or oozing).
  • Replace dressings right away with a clean dressing if they become loose or come off.
  • Place all used dressings and cleaning materials in a sealed plastic bag, and throw them away in the garbage.

What are the possible side effects of IMLYGIC®?

  • Common side effects of IMLYGIC® include tiredness, chills, fever, nausea, flu-like symptoms, and pain at treatment site.
  • Tell your doctor right away if you get any of the following:
  • Pain, burning, or tingling in a blister around the mouth or genitals or on the fingers or ears
  • Eye pain, light sensitivity, discharge from the eyes, or blurry vision
  • Weakness in arms or legs
  • Extreme drowsiness (feeling sleepy)
  • Mental confusion
  • If you think you have a herpes infection, inform your doctor. You or your doctor should call Amgen at
    1-855-IMLYGIC (1-855-465-9442) for follow-up testing, if needed.
  • Tell your doctor if you have any side effect that bothers you or does not go away.
  • These are not all the possible side effects of IMLYGIC®.

If you would like more information, talk with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or
call 1-800-FDA-1088.

Please see full Prescribing Information and Medication Guide for more information about IMLYGIC®.

Indication and Limitations of Use

IMLYGIC® (talimogene laherparepvec) is a prescription medication injected on the skin, beneath the skin, or in your lymph glands, to treat a type of skin cancer called melanoma when it can no longer be surgically removed.

IMLYGIC® may not help you live longer and may not shrink cancer in your organs (for example, lung or liver).

References:

1. IMLYGIC® (talimogene laherparepvec) Prescribing Information, BioVex, Inc., a subsidiary of Amgen, Inc.
2. Andtbacka RHI, Kaufman HL, Collichio F, et al. Talimogene laherparepvec improves durable response rate in patients with advanced melanoma. J Clin Oncol. 2015;33:2780-2788.
3. Andtbacka RHI, Kaufman HL, Collichio F, et al. Talimogene laherparepvec improves durable response rate in patients with advanced melanoma. J Clin Oncol. 2015;33(suppl Clinical Study Protocol):doi:10.1200/JCO.2014.58.3377.
4. Data on file, Amgen.