KEYTRUDA®Now Registered To Treat Malignant Pleural Mesothelioma, Biliary Tract Carcinoma & Merkel Cell Carcinoma

Auckland, New Zealand

MSD (tradename of Merck & Co., Inc., Rahway, N.J., USA (NYSE: MRK) announced today that KEYTRUDA is now registered to treat patients with the following cancers:

• Malignant Pleural Mesothelioma (MPM): KEYTRUDA as a first-line treatment may be combined with chemotherapy medicines to treat MPM, a cancer that affects the lining of the lungs and chest wall. This treatment is for adults and children when the cancer has spread or cannot be removed by surgery.;1,2
• Merkel Cell Carcinoma (MCC): KEYTRUDA may be used to treat MCC, a type of skin cancer, in adults and children when the cancer has spread or returned.;1,2
• Biliary Tract Cancer (BTC): KEYTRUDA may be combined with chemotherapy medicines to treat BTC, a cancer that affects the bile ducts or gallbladder. This treatment is for adults when the cancer has spread or cannot be removed by surgery.1,2

KEYTRUDA is not publicly funded for the treatment of patients with these cancers.

Vanessa Gascoigne, Merck Sharp & Dohme (New Zealand) Limited (MSD) Director, says, “We are excited about these new registrations as mesothelioma, Merkel cell carcinoma and biliary tract cancer are rare forms of cancer.”.3, 4, 5

Dr Terri-Ann Berry, Mesothelioma Support & Asbestos Awareness Trust Board Chair, says “Mesothelioma is a cancer primarily caused by asbestos exposure. Asbestos causes harm when a person is exposed to the tiny asbestos fibres. 3 It is most likely to be found in buildings built before the 2000s and mesothelioma usually develops 15-60 years after exposure. 6,3

“Pleural mesothelioma is a type of mesothelioma which affects the tissue lining around the lungs (pleura) and is the most common form of this cancer. The symptoms of mesothelioma may include – a cough that doesn’t go away, chest pain, shortness of breath, fatigue, unexplained weight loss, sweating at night, and fevers.” 3

Bile tract cancer affects the bile ducts and gallbladder. Symptoms may include yellowing of the skin and eyes, nausea and vomiting, weakness or tiredness, loss of appetite and weight, fever, right-side abdominal pain, dark urine, pale stools, and itchy skin. 2, 7

Merkel cell carcinoma is a rare type of skin cancer which tends to grow quickly. Merkel cell carcinomas most often start on skin that's exposed to the sun, like the face, neck, and arms, but it can occur anywhere. Merkel cell carcinomas typically appear as solid lumps or bumps on the skin, which can be pink, red, or purple in color. They are generally painless. 4

Vanessa Gascoigne, MSD New Zealand Director, adds, “KEYTRUDA is now registered for 31 indications including for the treatment of patients with certain types of advanced and early-stage cancers.1

““Thanks to the Government's increase in the medicines budget last year, eligible patients may access funded KEYTRUDA for 11 of those indications. Patients with any of the other 20 indications may access KEYTRUDA at their own expense through a private cancer center across New Zealand. 8,9 We recommend speaking to your doctor if you would like more information about these cancers.

“MSD will continue to work with the funding agency, Pharmac, in an effort to obtain funded access for more patients with cancer, including those with early-stage high-risk triple-negative breast cancer and stage III melanoma. 10

“We know people across New Zealand would benefit from faster funded access to cancer treatment. The sadness is that while KEYTRUDA is currently publicly funded for 11 indications, it is not funded for all patients in which it is indicated for.”

Please see accompanying Prescribing Information and Patient Information for KEYTRUDA.

KEYTRUDA® (pembrolizumab) is available as a 100 mg/4 mL concentrate for solution for infusion.

The KEYTRUDA Consumer Medicine Information (CMI) is available at www.medsafe.govt.nz.

KEYTRUDA is a Prescription Medicine and may be used in adults:

• After surgery to remove melanoma, non-small cell lung cancer or renal cell carcinoma to help prevent the cancer from coming back
• Before surgery to treat triple-negative breast cancer and then continued after surgery to help prevent the cancer from coming back
• To treat bladder cancer which has not spread to nearby tissues but is at high-risk of spreading and where bladder removal is not preferred
• To treat certain patients with the following types of advanced cancers:
• Melanoma
• Non-small cell lung cancer
• Malignant pleural mesothelioma (MPM)
• Classical Hodgkin Lymphoma (cHL)
• Urothelial carcinoma
• Head and neck squamous cell carcinoma
• Renal cell carcinoma
• Gastric or gastroesophageal junction adenocarcinoma
• Oesophageal carcinoma
• Cutaneous squamous cell carcinoma.
• Cervical cancer
• Endometrial carcinoma
• Triple-negative breast cancer
• A kind of cancer that can occur in any part of the body and is shown by a laboratory test to be microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)
• Colon or rectal cancer that is shown by a laboratory test to be MSI-H or dMMR
• Merkel cell carcinoma (MCC)
• Biliary tract carcinoma

KEYTRUDA may be used in children with MPM, cHL, MCC, MSI-H or dMMR cancer, or after surgery to remove melanoma. It is not known if KEYTRUDA is safe and effective in children with MSI-H or dMMR cancer of the brain or spinal cord (central nervous system cancers).

You should not be given KEYTRUDA if you are allergic to pembrolizumab or to any of the other ingredients listed at the end of the CMI.

KEYTRUDA can cause harm or death to unborn babies. Talk to your doctor if you are a woman who could become pregnant and use effective contraception while you are being treated with KEYTRUDA and for at least 4 months after the last dose of KEYTRUDA. Do not breastfeed while taking KEYTRUDA.

Serious immune-mediated side effects have occurred affecting the lungs, intestines, liver, kidneys, hormone glands, blood sugar levels, skin, other organs and in transplant recipients. Some of these side effects can sometimes become life-threatening and can lead to death. These side effects may happen anytime during treatment or even after your treatment has ended and you may experience more than one side effect at the same time. Serious infusion reactions have also occurred.

Very common side effects with KEYTRUDA alone include diarrhoea, nausea, itching, rash, joint pain, back pain, feeling tired, cough, patches of discoloured skin, stomach pain, decreased levels of sodium in blood and low levels of thyroid hormone.

When KEYTRUDA was given in combination with chemotherapy, hair loss, vomiting, decreased white-blood cell count, mouth sores, fever, decreased appetite, decreased number of red blood cells, decreased number of platelets in the blood and swelling of the lining of the digestive system (for example mouth, intestines) were also commonly reported.

When KEYTRUDA was given in combination with axitinib, high blood pressure, fatigue, low levels of thyroid hormone, decreased appetite, blisters or rash on palms of your hands and soles of your feet, increased liver enzyme levels, hoarseness, and constipation were also commonly reported.

When KEYTRUDA was given in combination with lenvatinib, high blood pressure, decreased appetite, low levels of thyroid hormone, vomiting, weight loss, headache, constipation, hoarseness, urinary tract infection, stomach-area (abdominal pain), blisters or rash on the palms of your hands and soles of your feet, protein in your urine, increased liver enzyme levels and feeling weak were also commonly reported.

The most common side effects when KEYTRUDA is given alone to children include fever, vomiting, headache, stomach pain, decreased number of red blood cells, cough, and constipation. (v54)

KEYTRUDA has risks and benefits. Talk to your doctor to see if KEYTRUDA is right for you. If symptoms continue or you have side effects, tell your doctor.

KEYTRUDA is funded to treat certain patients with the following types of advanced cancers: melanoma, non-small cell lung cancer, MSI-H or dMMR colorectal cancer, triple-negative breast cancer, head and neck squamous cell carcinoma, urothelial carcinoma, and classical Hodgkin lymphoma - further restrictions apply. KEYTRUDA is not funded for the treatment of all other cancers listed above.

Ask your health professional about the cost of the medicine and any other medical fees that may apply.

About MSD

At MSD, known as Merck & Co., Inc., Rahway, N.J., USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.msd.com and connect with us on X , LinkedIn and YouTube.

Copyright © 2025 Merck & Co., Inc., Rahway, NJ, USA, and its affiliates. All rights reserved. 
Merck Sharp & Dohme (New Zealand) Limited. Level 3, 123 Carlton Gore Road, Newmarket, Auckland. NZ-NZ-KEY-00972 V4 TAPS DA NP22434 March 2025

References

1.KEYTRUDA Data Sheet. Available at: https://www.medsafe.govt.nz/profs/Datasheet/k/Keytruda.pdf Accessed February 2025

2.KEYTRUDA Consumer Medicine Information. Available at: https://www.medsafe.govt.nz/Consumers/CMI/k/Keytruda.pdf Accessed February 2025

3. Mesothelioma Support and Asbestos Awareness Trust. What is Mesothelioma? Available at: https://www.msaatrust.org.nz/mesothelioma. Accessed February 2025

4. American Cancer Society.What is Merkel Cell Carcinoma (MCC)? Available at: https://www.cancer.org/cancer/types/merkel-cell-skin-cancer/about/what-is-merkel-cell-carcinoma.html Accessed February 2025

5. American Cancer Society. Key Statistics for Bile Duct Cancer. Available at: https://www.cancer.org/cancer/types/bile-duct-cancer/about/key-statistics.html Accessed March 2025

6.Worksafe: Asbestos in Aotearoa New Zealand July 2024. Available at: https://www.worksafe.govt.nz/dmsdocument/68250-asbestos-in-aotearoa-new-zealand/latest Accessed February 2025

7. Gut Cancer Foundation website. Gallbladder & Bile Duct Cancer. Available at: https://www.gutcancer.org.nz/gallbladder-and-bile-duct-cancer/ Accessed March 2025

8. Pharmac. News and resources. Update on new medicines funding after the budget uplift. Available at: https://www.pharmac.govt.nz/news-and-resources/news/update-on-new-medicines-funding-after-the-budget-uplift Accessed March 2025

9. Pharmac. Pharmaceutical Schedule. Available at: https://www.pharmac.govt.nz/pharmaceutical-schedule Accessed February 2025

10. Pharmac. Application Tracker. Available at: https://connect.pharmac.govt.nz/apptracker/s/global-search/pembrolizumabt Accessed February 2025

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