11/08/2025
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mirikizumab (Omvoh)
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Abbreviated
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For the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment.
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11/08/2025
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zanubrutinib (Brukinsa)
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Abbreviated
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As monotherapy for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy
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11/08/2025
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01/07/2025
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brentuximab vedotin (Adcetris)
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Full
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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).
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TBC
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03/09/2024
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maralixibat (Livmarli)
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Full
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For treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 2 months of age and older.
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TBC
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TBC
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ribociclib (Kisqali)
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Full
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In combination with an aromatase inhibitor is indicated for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer at high risk of recurrence.s
In pre- or perimenopausal women, or in men, the aromatase inhibitor should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.
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TBC
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TBC
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maralixibat (Livmarli)
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Resubmission
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Indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) 2 months of age and older.
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TBC
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TBC
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blinatumomab (Blincyto)
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Full
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Treatment of adult patients with Philadelphia chromosome (Ph)-negative, CD19-positive, B-cell precursor acute lymphoblastic leukaemia (ALL) in the consolidation phase.
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TBC
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TBC
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durvalumab (Imfinzi)
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Full
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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).
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TBC
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TBC
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dupilumab (Dupixent)
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Full
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In adults as add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate.
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TBC
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TBC
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delgocitinib (Anzupgo)
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Full
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Treatment of moderate to severe chronic hand eczema (CHE) in adults for whom topical corticosteroids (TCS) are inadequate or inappropriate.
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TBC
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TBC
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nivolumab (Opdivo)
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Full
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In combination with ipilimumab (YERVOY®) (NIVO + IPI) is indicated for the treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability high (MSI-H) colorectal cancer (CRC) in the following settings: first-line treatment of unresectable or metastatic CRC.
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TBC
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TBC
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marstacimab (Hympavzi)
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Full
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For routine prophylaxis of bleeding episodes in patients 12 years of age and older, weighing at least 35 kg, with:
- severe haemophilia A (congenital factor VIII deficiency, FVIII < 1%)
without factor VIII inhibitors, or
- severe haemophilia B (congenital factor IX deficiency, FIX < 1%) without
factor IX inhibitors
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TBC
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TBC
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ripretinib (Qinlock)
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Resubmission
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Treatment of adult patients with advanced gastrointestinal stromal tumour (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib.
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TBC
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TBC
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capivasertib (Truqap)
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Full
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In combination with fulvestrant for the treatment of adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative (defined as IHC 0 or 1+, or IHC 2+/ISH-) locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following recurrence or progression on or after an endocrine based regimen.
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TBC
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TBC
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nusinersen (Spinraza)
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Ultra-orphan reassessment
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For treatment of 5q spinal muscular atrophy (SMA).
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TBC
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TBC
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rucaparib (Rubraca)
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Full
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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.
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TBC
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TBC
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belantamab mafodotin (Blenrep)
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Full
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In combination with pomalidomide and dexamethasone (BPd) for the treatment of adult patients with multiple myeloma who have received at least one prior therapy including lenalidomide.
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TBC
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TBC
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belantamab mafodotin (Blenrep)
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Full
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In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
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TBC
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TBC
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durvalumab (Imfinzi)
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Full
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Treatment of adults with limited-stage small-cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy (CRT).
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TBC
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TBC
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ataluren (Translarna)
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Ultra-orphan reassessment
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Treatment of Duchenne muscular dystrophy resulting from a nonsense mutation in the dystrophin gene, in ambulatory patients aged 2 years and older.
The presence of a nonsense mutation in the dystrophin gene should be determined by genetic testing.
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