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SMC ID Date Medicine Submission Type Indication
SMC2693 08/07/2024 trastuzumab deruxtecan (Enhertu) Non submission

As monotherapy for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.

SMC2692 08/07/2024 remimazolam (Byfavo) Non submission

In adults for intravenous induction and maintenance of general anaesthesia.

SMC2691 08/07/2024 lenacapavir (Sunlenca) Non submission

Film-coated tablets: in combination with other antiretroviral(s) for the treatment of adults with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen, for oral loading prior to administration of long-acting lenacapavir injection.

Solution for injection: in combination with other antiretroviral(s) for the treatment of adults with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.

SMC2670 08/07/2024 follitropin delta (Rekovelle) Abbreviated

Controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle.

SMC2641 08/07/2024 voretigene neparvovec (Luxturna) Ultra-orphan reassessment

For the treatment of adult and paediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells.

SMC2645 08/07/2024 nivolumab / relatlimab (Opdualag) Full

For treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and over.

SMC2642 08/07/2024 empagliflozin (Jardiance) Full

In adults for the treatment of chronic kidney disease.

SMC2644 08/07/2024 pembrolizumab (Keytruda) Full

In combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1.

SMC2665 08/07/2024 pegunigalsidase alfa (Elfabrio) Resubmission

Long-term enzyme replacement therapy (ERT) in adult patients with confirmed diagnosis of Fabry disease (FD) (deficiency of alpha galactosidase).

SMC2660 08/07/2024 pembrolizumab (Keytruda) Full

in combination with fluoropyrimidine and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1.

SMC2651 08/07/2024 birch bark extract (Filsuvez) Ultra-orphan initial assessment

For treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in patients aged 6 months and older.

SMC2682 10/06/2024 dupilumab (Dupixent) Non submission

For treatment of eosinophilic esophagitis in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy.

SMC2655 10/06/2024 etrasimod (Velsipity Abbreviated

For the treatment of patients 16 years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biological agent.

SMC2683 10/06/2024 pembrolizumab (Keytruda) Non submission

In combination with gemcitabine and cisplatin for the first-line treatment of locally advanced unresectable or metastatic biliary tract carcinoma in adults.

SMC2681 10/06/2024 decitabine cedazuridine (Inaqovi) Non submission

As monotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction chemotherapy.

SMC2680 10/06/2024 clostridium botulinum neurotoxin type A (Xeomin) Non submission

Focal spasticity of the lower limb affecting the ankle joint.

SMC2626 10/06/2024 voxelotor (Oxbryta) Full

Treatment of haemolytic anaemia due to sickle cell disease (SCD) in adults and paediatric patients 12 years of age and older as monotherapy or in combination with hydroxycarbamide

SMC2632 10/06/2024 epcoritamab (Tepkinly) Full

As monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy

SMC2614 10/06/2024 glofitamab (Columvi) Full

As monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B‑cell lymphoma (DLBCL), after two or more lines of systemic therapy.

SMC2636 10/06/2024 momelotinib (Omjjara) Abbreviated

For the treatment of disease-related splenomegaly or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis and who are Janus Associated Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.

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Publication due date SMC meeting date Medicine Submission Type Indication
12/08/2024 02/07/2024 etranacogene dezaparvovec (Hemgenix) Full

For treatment of severe and moderately severe haemophilia B (congenital Factor IX deficiency) in adult patients without a history of Factor IX inhibitors.

12/08/2024 02/07/2024 trifluridine tipiracil (Lonsurf) Full

In combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (CRC) who have received two prior anticancer treatment regimens including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and/or anti-EGFR agents.

09/09/2024 06/08/2024 dabrafenib (Finlee) Full
  • In combination with trametinib for the treatment of paediatric patients aged 1 year and older with low-grade glioma (LGG) with a BRAF V600 mutation who require systemic therapy.

  • In combination with trametinib for the treatment of paediatric patients aged 1 year and older with high-grade glioma (HGG) with a BRAF V600 mutation who have received at least one prior radiation and/or chemotherapy treatment.
09/09/2024 06/08/2024 ivosidenib (Tibsovo) Full

As monotherapy for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R 132 mutation who were previously treated by at least one prior line of systemic therapy.

09/09/2024 06/08/2024 teclistamab (Tecvayli) Full

As monotherapy is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM), who have received at least three prior therapies, including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.

09/09/2024 06/08/2024 elranatamab (Elrexfio) Full

As monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.

09/09/2024 06/08/2024 fosdenopterin (Nulibry) Ultra-orphan initial assessment

Treatment of patients with molybdenum cofactor deficiency (MoCD) Type A.

07/10/2024 03/09/2024 rezafungin acetate (Rezzayo) Full

For the treatment of invasive candidiasis in adults. Consideration should be given to official guidance on the appropriate use of antifungal agents.

07/10/2024 03/09/2024 selinexor (Nexpovio) Full

In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy

07/10/2024 03/09/2024 selinexor (Nexpovio) Full

In combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

TBC 10/01/2023 levodopa/carbidopa/entacapone (Lecigon) Full

For treatment of advanced Parkinson's disease with severe motor fluctuations and hyperkinesia or dyskinesia when available oral combinations of Parkinson medicinal products have not given satisfactory results

TBC 07/02/2023 tebentafusp (Kimmtrak) Full

as monotherapy for the treatment of human leukocyte antigen (HLA)-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma

TBC 02/04/2024 linzagolix (Yselty) Full

For treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age

TBC somapacitan (Sogroya) Abbreviated
TBC futibatinib (Lytgobi) Abbreviated

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.

TBC TBC relugolix / estradiol / norethisterone acetate (Ryeqo) Full

In adult women of reproductive age for symptomatic treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis.

TBC TBC danicopan (Voydeya) Full

As an add-on to ravulizumab or eculizumab for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have residual haemolytic anaemia.

TBC TBC iptacopan (Fabhalta) Full

Paroxysmal nocturnal hemoglobinuria (PNH), who have haemolytic anaemia.

TBC TBC quizartinib (Vanflyta) Full

In combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by quizartinib single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukaemia (AML) that is FMS-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD) positive.

TBC TBC lecanemab (Leqembi) Full

To slow progression of mild cognitive impairment and mild dementia due to Alzheimer’s disease in adults.

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