Combination for advanced endometrial cancer receives funded access via the Pharmaceutical Benefits Scheme

June 5, 2023 7:05 am Australia/Sydney

Eligible women with advanced, metastatic, or recurrent endometrial carcinoma can now access combination therapy KEYTRUDA® (pembrolizumab) with LENVIMA® (lenvatinib) via the Pharmaceutical Benefits Scheme (PBS) as an option following treatment with chemotherapy.¹

The availability of funded access for KEYTRUDA with LENVIMA means that eligible women can have affordable and equitable access to this treatment option.

Endometrial cancers begin in the lining of the uterus (endometrium) and account for about 95% of all uterine cancer cases.² In 2018 it was the most commonly diagnosed gynaecological cancer in Australia and most frequently in women over the age of 60.³

In 2022, it is estimated that more than 3,300 new cases of endometrial cancer were diagnosed, and an estimated 660 women died from the disease.⁴

The chances of surviving for at least five years after a uterine cancer diagnosis (of which approximately 95% are endometrial cancer) in Australia is 83%.^4,5

Associate Professor Yoland Antill, Medical Oncologist based in Melbourne says "Endometrial cancer is the most common of gynaecological cancers in Australia. While thankfully many who are diagnosed at an early stage are cured of their cancer with surgery, but for those with advanced or recurrent disease, the story is not so rosy. The proportion who remain alive at 5 years is less than 20%."

"Funded access to KEYTRUDA and LENVIMA gives doctors another option of treatment with patients who have advanced or recurrent endometrial cancer." she added.

Currently, there are no screening tests or exams to find endometrial cancer early in women who are at risk, and whilst improved diet and exercise could help to lower the risk, there is no simple method to prevent women from developing this cancer.^6,7,8

About KEYTRUDA⁹

Endometrial carcinoma indication: KEYTRUDA (pembrolizumab), in combination with lenvatinib, is indicated for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

KEYTRUDA Minimum Consumer Medicine Information.¹⁰ KEYTRUDA contains the active ingredient pembrolizumab. KEYTRUDA is a medicine that may treat certain cancers by working with the immune system. KEYTRUDA may be given in combination with other anticancer medicines. Not everybody is suitable to have KEYTRUDA as a treatment for their cancer.

Before using KEYTRUDA, a doctor will check if a person with cancer has a disease of the immune system like Crohn's, ulcerative colitis, or lupus; had an organ transplant (like a kidney transplant) or a bone marrow (stem cell) transplant that used donor stem cells (allogeneic); have pneumonia or swelling of the lungs (called pneumonitis); have liver damage. If you are pregnant or plan to become pregnant, tell your health care provider as KEYTRUDA can harm your unborn baby. Effective birth control must be used during treatment and for at least 4 months after the final dose of KEYTRUDA. Tell your health care provider if you are breastfeeding or plan to breastfeed.

Like all medicines, KEYTRUDA can cause side effects, although not everybody gets them. KEYTRUDA can cause the immune system to attack normal organs and tissues in any area of the body and can affect the way they work. Sometimes these problems can become severe or life-threatening. More than one side effect can occur at the same time and side effects can arise at any time during treatment and even after the treatment has ended. These can include immune system problems affecting: the lungs; intestines; liver, kidneys; skin, hormone glands (especially thyroid, pituitary, and adrenal glands) and blood sugar levels. Infusion reactions can sometimes be severe and life-threatening. Rejection of a transplanted organ; and complications in people with a bone marrow transplant that uses donor stem cells (allogeneic) can occur. Very common side effects include diarrhoea, nausea, itching, rash, joint pain, back pain, feeling tired, cough, patches of skin which have lost colour, stomach pain, decreased sodium levels in the blood, fever, infections of the upper respiratory tract, low levels of thyroid hormone, a decreased number of white blood cells (which are important in fighting infection) in patients with primary mediastinal B-cell lymphoma. These are not the only side effects that occur with KEYTRUDA.

For further information read the KEYTRUDA Consumer Medicine Information available at www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2015-CMI-01640-1 and speak to your doctor.

About LENVIMA¹¹

Endometrial cancer indication. LENVIMA, in combination with pembrolizumab, is indicated for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

Lenvima® (lenvatinib mesilate) 4mg and 10 mg hard capsules.¹² Lenvima is used to treat liver cancer and thyroid cancer in adults when radioactive iodine treatment has not helped stop your disease. It is also use in combination with everolimus to treat patients with advanced kidney cancer where other treatments have not helped stop the disease and in combination with pembrolizumab to treat a kind of uterine cancer called endometrial carcinoma, if laboratory tests show the cancer is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) and other treatments have not helped stop the disease.

Lenvima should not be takenif you have an allergy to lenvatinib, the active ingredient or to any of the other ingredients listed in the Consumer Medicine Information (CMI).Check with your doctor if you have high blood pressure; have a history of heart problems or stroke; are over 65 years of age; need to have or have had recent surgery or radiotherapy; have liver or kidney problems; have or have had pain in the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth; are receiving or have received some medicines used to treat osteoporosis or cancer; belong to an ethnic group other than white or Asian, weigh less than 60 kg; have a history of abnormal passageways (known as fistula). Very common side effects include high or low blood pressure; loss of appetite or weight loss, feeling sick and being sick, constipation, diarrhoea, stomach pain, indigestion; feeling sleepy (drowsiness or somnolence); feeling weak; cough or hoarse voice; swelling of the legs; rash; dry, sore or inflamed mouth, odd taste sensation; swelling and inflammation of the joints, and stiff muscles, bones and joints; feeling dizzy; hair loss; bleeding (most commonly nose bleeds); trouble sleeping; increased protein in the urine; urinary infections; pain (muscle, joint, headache, back); redness, soreness and swelling of the skin on the hands and feet; underactive thyroid (tiredness, weight gain, constipation, feeling cold, dry skin); low levels of sodium, potassium and calcium in blood tests; high levels of cholesterol and thyroid stimulating hormone in blood tests; decreases in the number of white blood cells; bruising and difficulty wound healing. Lenvima has risks and benefits. Use strictly as directed.

For more information on Lenvima including side effects see the CMI at https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2016-CMI-01213-1 or speak with your doctor.

PBS information: This combination is available via the Pharmaceutical Benefits Scheme. Authority required (STREAMLINED). Consult the Pharmaceutical Benefits Scheme at www.pbs.gov.au for full information.

1. Australian Government. Pharmaceutical Benefits Scheme. www.pbs.gov.au June 2023.
2. Cancer Council Australia. Uterine Cancer Factsheet. https://www.cancer.org.au/cancer-information/types-of-cancer/uterine-cancer Accessed May 2023
3. Australian Institute of Health and Welfare (AIHW).Gynaecological Cancers in Australia - An Overview. https://www.aihw.gov.au/reports/cancer/cancer-data-in-australia/contents/cancer-summary-data-visualisation Accessed May 2023
4. Australian Government. Cancer Australia. Uterine Cancer Statistics. https://www.canceraustralia.gov.au/cancer-types/uterine-cancer/statistics Accessed May 2023
5. Makker, V., Green, A.K., Wenham, R.M. et al. New therapies for advanced, recurrent, and metastatic endometrial cancers. gynaecol oncol res pract 4, 19 (2017). https://doi.org/10.1186/s40661-017-0056-7
6. QIMR Berghofer Medical Research Institute. Endometrial Cancer https://www.qimrberghofer.edu.au/our-research/cancer/endometrial-cancer/ Accessed May 2023
7. Australian Government. Cancer Australia. Endometrial Cancer. Overweight and Obesity. https://www.canceraustralia.gov.au/cancer-types/endometrial-cancer/awareness/lifestyle/overweight-and-obesity Accessed May 2023
8. National Institute of Health. https://www.cancer.gov/about-cancer/causes-prevention/risk/obesity/physical-activity-fact-sheet Accessed May 2023
9. KEYTRUDA (pembrolizumab) Product Information. https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2023-PI-01512-1&d=20230521172310101 Accessed May 2023
10. KEYTRUDA (pembrolizumab) Consumer Medicine Information. https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2023-CMI-01513-1 Accessed May 2023
11. LENVIMA (lenvatinib) Product Information. https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2016-PI-01212-1 Accessed May 2023
12. LENVIMA (lenvatinib) Consumer Medicine Information. https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2016-CMI-01213-1 Accessed May 2023

Public link

Please use the above public link if you want to share this noodl on another website.