Astellas Pharma Australia has announced that the indication forXTANDI®(enzalutamide) has been extended by the Therapeutic Goods Administration (TGA) to include the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) following the failure of androgen deprivation therapy (ADT) in whom chemotherapy is not yet indicated.
Prostate cancer that has extended beyond the prostate into the surrounding tissue, into other organs or into distant parts of the body, is called advanced prostate cancer.1 Up to 40% of men with prostate cancer develop metastatic disease and a large number of men with advanced prostate cancer eventually develop resistance to ADT, and progress to mCRPC.1
XTANDI had previously been approved by the TGA for use in mCRPC - but only where the patient had previously received docetaxel (i.e. chemotherapy).
Associate Professor Anthony Lowe, CEO of Prostate Cancer Foundation of Australia, welcomes new treatment options for men with advanced prostate cancer.
"Improving clinical outcomes for men with advanced prostate cancer is a major focus for clinicians and prostate cancer advocates in Australia. The prospect of having access to medicines that can be introduced prior to chemotherapy should be a major focus for the future," said Assoc. Prof. Lowe.
"This approval is an important milestone for patients and their clinicians, but the main issue is to look at how access to new, evidence-based medicines and/or indications can be improved to further help men with advanced prostate cancer. Reimbursement will clearly be a big part of the equation."
XTANDI (enzalutamide) is an oral, once-daily androgen receptor signalling inhibitor.
Prostate cancer is the most common cancer in Australian men (excluding non-melanoma skin cancer), with almost 20,000 men diagnosed each year and close to 120,000 Australian men currently living with the disease.2 It is estimated that 1 in 5 Australian men will be diagnosed with prostate cancer by the age of 85.2
MINIMUM PRODUCT INFORMATION: XTANDI® (enzalutamide) 40 mg soft capsules. Indications: *Treatment of patients with metastatic castration-resistant prostate cancer: following failure of androgen deprivation therapy in whom chemotherapy is not yet indicated or who have previously received docetaxel.Contraindications: Patients with known hypersensitivity to enzalutamide or to any of the excipients in the formulation; women who are, or may become, pregnant. Not indicated for use in women. Precautions:
XTANDI should only be prescribed by a medical practitioner who is experienced with the treatment of prostate cancer and the use of antineoplastic endocrine therapies. Clinically significant: risk of seizure, *posterior reversible encephalopathy syndrome, drug interactions. Refer to XTANDI Approved Product Information for additional precautions. Interactions: Strong inhibitors (e.g. gemfibrozil) or inducers (e.g. rifampicin) of CYP2C8, paracetamol, midazolam, warfarin and coumarin-like anticoagulants, omeprazole, colchicine, dabigatran etexilate, digoxin. Groups of medicinal products that can be affected include, but are not limited to: analgesics, antibiotics, anticancer agents, anticoagulants, antiepileptics, antipsychotics, betablockers, calcium channel blockers, cardiac glycosides, corticosteroids, HIV antivirals, hypnotics, statins metabolised by CYP3A4, thyroid agents. Adverse effects: Very common (≥10%): asthenic conditions, peripheral oedema, back pain, arthralgia, musculoskeletal pain, diarrhoea, hot flush, headache, upper respiratory tract infection, *constipation, *hypertension, *dizziness, *dyspnoea, *fall, *decreased appetite, *weight decreased. Common (≥1% and <10%): muscular weakness, musculoskeletal stiffness, spinal cord compression and cauda equina syndrome, paraesthesia, mental impairment disorders, hypoesthesia, lower respiratory tract and lung infection, insomnia, anxiety, haematuria, pollakiuria, non-pathologic fractures, pruritus, dry skin, epistaxis, *dysgeusia, *restless legs syndrome, *gynaecomastia.Dosage: The recommended dose is 160 mg (four 40 mg capsules) as a single oral daily dose. Swallow capsules whole with water. Do not chew, dissolve, or open the capsules. If a patient experiences a ≥ Grade 3 toxicity or an intolerable adverse reaction, withhold dosing for one week or until symptoms improve to ≤ Grade 2, then resume at the same or a reduced dose (120 mg or 80 mg) if warranted. The concomitant use of strong CYP2C8 inhibitors should be avoided if possible, but if co-administered, reduce dose to 80 mg once daily. Based on Product Information, 6 Nov 2015.
*Please note changes in Product Information.
Xtandi is currently listed on the PBS with authority required for the treatment of castration resistant metastatic carcinoma of the prostate post-docetaxel therapy. Refer to the PBS Schedule for full restricted benefit information. Xtandi is not listed on the PBS for the treatment of castration resistant metastatic carcinoma of the prostate prior to docetaxel therapy.
