Cancer therapies receive recommendations from the Pharmaceutical Benefits Advisory Committee
April 27, 2022 10:00 am Australia/Sydney
Eligible Australians with squamous cell carcinoma of the head and neck (SCCHN), or advanced endometrial cancer could receive funded access to additional treatment options following recommendations made by the independent Pharmaceutical Benefits Advisory Committee (PBAC).1
These recommendations made by the PBAC are an important step in making these medicines reimbursed for eligible patients.
Prashant Nikam, Managing Director, MSD Australia & New Zealand said, “These are welcome milestones that recognise the role treatment innovation can play in supporting patient outcomes.”
“Australians deserve the broadest and best possible access to medicines. Patients need confidence that the Australian system for reviewing and making new medicines available is robust enough to ensure rapid access to medicines,” he added.
Richard Vines, Rare Cancers Australia said, “Removing the financial stress of the cancer care journey is critical to Australians accessing the support and treatment they need. More patients are having to rely on family and friends to help pay for treatment and the substantial out-of-pocket costs they incur along the way.”
“We need measures in place that can better protect Australia’s most vulnerable patients from this financial duress. These recommendations by the PBAC are an important step towards affordable access to these medicines for eligible Australian’s living with cancer”, he added.
Full details of the PBAC recommendations are available from the PBS website1 and include:
- KEYTRUDA (pembrolizumab) in combination with LENVIMA (lenvatinib) for advanced endometrial cancer. The PBAC recommended the listing of pembrolizumab in combination with lenvatinib for the treatment of patients with advanced endometrial cancer who have disease progression following prior systemic therapy regardless of biomarker status.
- KEYTRUDA for SCCHN. The PBAC recommended listing of pembrolizumab monotherapy for first line treatment of recurrent or metastatic SCCHN patients with combined positive score (CPS) ≥20 in their tumour sample, and pembrolizumab in combination with platinum-based chemotherapy irrespective of CPS score.
About KEYTRUDA2 Endometrial carcinoma indication: KEYTRUDA (pembrolizumab), in combination with LENVIMA® (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.
Squamous Cell Carcinoma of the Head and Neck (SCCHN) indication: KEYTRUDA (pembrolizumab), as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is indicated for the first-line treatment of patients with metastatic or unresectable recurrent HNSCC, and whose tumours express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by a validated test.
KEYTRUDA SELECTED SAFETY INFORMATION2 Precautions: Immune-mediated adverse reactions (ImARs), incl. severe and fatal cases, have occurred in patients receiving KEYTRUDA. These have included, but not limited to: pneumonitis, colitis, hepatitis, hepatoxicity (in combination with axitinib), nephritis, endocrinopathies (adrenal insufficiency, hypophysitis, type 1 diabetes mellitus, hyperthyroidism, hypothyroidism, thyroiditis), severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis and bullous pemphigoid), uveitis, myositis, Guillain-Barre syndrome, pancreatitis, encephalitis, sarcoidosis, myasthenic syndrome/myasthenia gravis (incl. exacerbation), myelitis, vasculitis, myocarditis, pericarditis and pericardial effusion, peripheral neuropathy, sclerosing cholangitis, solid organ transplant rejection, severe infusion reactions (hypersensitivity, anaphylaxis) and complications of allogeneic HSCT. ImARs have occurred after discontinuation of treatment with KEYTRUDA. ImARs can affect more than one body system simultaneously. Thyroid and liver function tests should be performed at baseline, periodically during treatment and as indicated based on clinical evaluation. Withhold or discontinue KEYTRUDA to manage adverse reactions as described in the Product Information. Adverse events: In patients with endometrial carcinoma treated with KEYTRUDA/LENVIMA, the following adverse events occurred at a rate >20% and at a rate higher than doxorubicin or paclitaxel were: hypothyroidism (67% vs 0.9%), hypertension (67% vs 6%), haemorrhagic events (25% vs 15%), fatigue (58% vs 54%), diarrhoea (55% vs 20%), nausea (49% vs 47%), vomiting (37% vs 21%), stomatitis (35% vs 26%), abdominal pain (34% vs 21%), constipation (27% vs 25%), musculoskeletal disorders (53% vs 27%), decreased appetite (44% vs 21%), weight loss (34% vs 6%), proteinuria (29% vs 3.4%), urinary tract infection (31% vs 13%) , headache (26% vs 9%), dysphonia (22% vs 0.6%), palmar-plantar erythrodysesthesia (23% vs 0.9%) and rash (20% vs 4.9%). Fatal adverse events have occurred. In patients with head and neck cancer, KEYTRUDA was discontinued for adverse reactions in 12% of patients in the KEYTRUDA single agent arm. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were sepsis (1.7%) and pneumonia (1.3%). Adverse reactions leading to the interruption of KEYTRUDA occurred in 31% of patients; the most common adverse reactions leading to interruption of KEYTRUDA (≥2%) were pneumonia (2.3%), pneumonitis (2.3%), and hyponatremia (2%). KEYTRUDA was discontinued for adverse reactions in 16% of patients in the combination arm. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonia (2.5%), pneumonitis (1.8%), and septic shock (1.4%). Adverse reactions leading to the interruption of KEYTRUDA occurred in 45% of patients; the most common adverse reactions leading to interruption of KEYTRUDA (≥2%) were neutropenia (14%), thrombocytopenia (10%), anaemia (6%), pneumonia (4.7%), and febrile neutropenia (2.9%). Contraindications: None.
Refer to the Consumer Medical Information leaflet, available online or your doctor or pharmacist for further information about KEYTRUDA.
About LENVIMA3 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.4 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 taken if 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 or speak with your doctor.
PBS information: KEYTRUDA for SCCHN, and KEYTRUDA in combination with LENVIMA for advanced endometrial cancer are not listed on the Pharmaceutical Benefits Scheme (PBS).
- Australian Government. Department of Health. Pharmaceutical Benefits Scheme. https://www.pbs.gov.au/pbs/industry/listing/elements/pbac-meetings/pbac-outcomes/recommendations-made-by-the-pbac-march-2022 Accessed April 2022
- KEYTRUDA Product Information. https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2015-PI-01639-1&d=20220329172310101 Accessed April 2022
- LENVIMA Product Information https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2016-CMI-01213-1 Accessed April 2022
- LENVIMA Consumer Medicine Information.https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2016-CMI-01213-1 Accessed April 2022