Medicines advice

Treatment of HLA-A*02:01-positive adult patients with advanced (unresectable or metastatic) uveal melanoma.

In adults for the treatment of chronic kidney disease (CKD).

For treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

For treatment of adult patients with polyneuropathy associated with hereditary transthyretin-mediated amyloidosis (ATTRv).

Monotherapy as adjuvant treatment for adult patients with Stage IB (tumours ≥ 4cm) to IIIA (7th edition of the UICC/AJCC-staging system) anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) following complete tumour resection.

Treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.

For the treatment of active moderate to severe hidradenitis suppurativa (HS) in adults with an inadequate response to conventional systemic HS therapy.

In combination with enzalutamide for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.

Treatment of adult patients with advanced gastrointestinal stromal tumour (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib.

For the treatment of flares in adult patients with generalised pustular psoriasis (GPP) as monotherapy.

In combination with carboplatin and pemetrexed for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations after failure of prior therapy including an EGFR tyrosine kinase inhibitor (TKI).

As monotherapy for the first-line treatment of adult patients with advanced NSCLC who are ineligible for platinum-based therapy.

As monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib.

For the treatment of seizures associated with Lennox-Gastaut syndrome as an add-on therapy to other anti-epileptic medicines for patients 2 years of age and older.

Lecanemab is indicated for the treatment of mild cognitive impairment and mild dementia due to Alzheimer’s disease in adult patients that are apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers.

Reduction of elevated intraocular pressure (IOP) in adult patients with primary open-angle glaucoma or ocular hypertension (OHT) for whom monotherapy with a prostaglandin or netarsudil provides insufficient IOP reduction.

As monotherapy for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.

In combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired human immunodeficiency-1 (HIV-1) infection in high-risk adults and adolescents, weighing at least 35 kg.

in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).

Monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2−negative locally advanced or metastatic breast cancer (mBC). Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments. Patients with HR+ breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy.

Add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older.

In adults for treatment of neovascular (wet) age-related macular degeneration (nAMD)

As monotherapy for the treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible fibroblast growth factor receptor 3 (FGFR3) genetic alterations who have previously received at least one line of therapy containing a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-(L)1) inhibitor in the unresectable or metastatic treatment setting.

As monotherapy for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with available therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, with or without an anti-vascular endothelial growth factor (VEGF) therapy and, if rat sarcomas virus (RAS) wildtype and medically appropriate, an anti-epidermal growth factor receptor (EGFR) therapy.

For the prevention of ototoxicity caused by cisplatin chemotherapy in patients 1 month to < 18 years of age with localised, non-metastatic, solid tumours.

For the treatment of transfusion-dependent β-thalassaemia in patients 12 years of age and older for whom haematopoietic stem cell transplantation is appropriate and a human leukocyte antigen (HLA)-matched related haematopoietic stem cell (HSC) donor is not available.

for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD) in adult patients that are apolipoprotein E ε4 (APOE4) heterozygotes on non-carriers.

Treatment of patients aged 12 years and older with acute graft versus host disease who have inadequate response to corticosteroids.

In combination with tremelimumab for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma.

In combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with advanced NSCLC whose tumours have EGFR exon 19
deletions or exon 21 (L858R) substitution mutations.

Treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease as defined by clinical or imaging features.

For treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 2 months of age and older.

In combination with carboplatin and pemetrexed for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) Exon20 insertion mutations.

As monotherapy for the maintenance treatment of adult patients with
advanced (FIGO Stages III and IV) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.

As an add on to standard therapy for the treatment of adult patients with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor antibody positive (AChR-Ab+).

As monotherapy for the treatment of adults and adolescents 12 years and older with advanced rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC).

ANTICIPATED: As monotherapy for the treatment of adults and adolescents 12 years and older with advanced RET fusion-positive thyroid cancer (TC) who are radioactive iodine-refractory (if radioactive iodine is appropriate).

Treatment of adult patients with previously untreated cell membrane receptor 30-positive (CD30+) Stage III or IV Hodgkin lymphoma (HL) in combination with doxorubicin, vinblastine and dacarbazine (AVD).

Treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.

In combination with carboplatin and paclitaxel for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, followed by maintenance treatment with:

• durvalumab as monotherapy in endometrial cancer that is mismatch repair deficient (dMMR)
• durvalumab in combination with olaparib in endometrial cancer that ismismatch repair proficient (pMMR).