Search Filters
Advanced Search
SMC ID Date Medicine Submission Type Indication
SMC2598 12/02/2024 dupilumab (Dupixent) Full

Treatment of adults with moderate-to-severe prurigo nodularis (PN) who are candidates for systemic therapy.

SMC2592 12/02/2024 secukinumab (Cosentyx) Full

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

SMC2590 12/02/2024 cabozantinib (Cabometyx) Full

As monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not eligible to radioactive iodine (RAI) who have progressed during or after prior systemic therapy.

SMC2623 12/02/2024 difelikefalin (Kapruvia) Full

Treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult patients on haemodialysis.

SMC2609 12/02/2024 loncastuximab tesirine (Zynlonta) Full

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

SMC2658 12/02/2024 ravulizumab (Ultomiris) Non submission

Treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin 4 (AQP4) antibody-positive.

SMC2657 12/02/2024 ravulizumab (Ultomiris) Non submission

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

SMC2588 15/01/2024 burosumab (Crysvita) Ultra-orphan reassessment

Treatment of X-linked hypophosphataemia in children and adolescents aged 1 to 17 years with radiographic evidence of bone disease.

SMC2589 15/01/2024 pembrolizumab (Keytruda) Full

As monotherapy for the treatment of the following MSI H or dMMR tumours in adults with:

  • unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy;
  • advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation;
  • unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy.
SMC2597 15/01/2024 belantamab mafodotin (Blenrep) Full

Monotherapy 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 one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

SMC2647 15/01/2024 setmelanotide (Imcivree) Non submission

Treatment of obesity and the control of hunger associated with genetically confirmed Bardet‑Biedl syndrome (BBS) in adults and children 6 years of age and above.

SMC2646 15/01/2024 axicabtagene ciloleucel (Yescarta) Non submission

Treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy.

SMC2640 11/12/2023 osilodrostat (Isturisa) Non submission

For treatment of endogenous Cushing’s syndrome in adults.

SMC2639 11/12/2023 lumasiran (Oxlumo) Non submission

For treatment of primary hyperoxaluria type 1 (PH1) in all age groups.

SMC2638 11/12/2023 amivantamab (Rybrevant) Non submission

As monotherapy for treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) Exon 20 insertion mutations, after failure of platinum-based chemotherapy.

SMC2625 11/12/2023 degarelix (Firmagon) Abbreviated
  • for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy

  • as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer
SMC2606 11/12/2023 cipaglucosidase alfa (Pombiliti) Abbreviated

As a long-term enzyme replacement therapy used in combination with the enzyme stabiliser miglustat for the treatment of adults with late-onset Pompe disease (LOPD; acid α-glucosidase [GAA] deficiency.

SMC2584 11/12/2023 cemiplimab (Libtayo) Reassessment

As monotherapy for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation.

SMC2581 11/12/2023 deucravacitinib (Sotyktu) Full

Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

SMC2619 11/12/2023 nivolumab (Opdivo) Full

In combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable (tumours ≥ 4 cm or node positive) non-small cell lung cancer in adults.

Load more
Publication due date SMC meeting date Medicine Submission Type Indication
11/03/2024 06/02/2024 ivosidenib (Tibsovo) Full

In combination with azacitidine for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not eligible to receive standard induction chemotherapy.

11/03/2024 06/02/2024 talazoparib (Talzenna) Full

As monotherapy for the treatment of adult patients with germline BRCA1/2 mutations, who have HER2-negative locally advanced or metastatic breast cancer. Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy.

11/03/2024 06/02/2024 axicabtagene ciloleucel (Yescarta) Full

Treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy.

11/03/2024 06/02/2024 olaparib (Lynparza) Full

In combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer in whom chemotherapy is not clinically indicated.

11/03/2024 foslevodopa-foscarbidopa (Produodopa) Abbreviated

Treatment of advanced levodopa-responsive Parkinson’s disease (PD) with severe motor fluctuations and hyperkinesia or dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results.

08/04/2024 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.

08/04/2024 mirikizumab (Omvoh) Abbreviated

For treatment of adults with moderately to severely active ulcerative colitis who are intolerant of, or whose disease has had an inadequate response or loss of response to, either conventional therapy or a biologic or have medical contraindications to such therapies.

08/04/2024 05/03/2024 ritlecitinib (Litfulo) Full

Treatment of severe alopecia areata in adults and adolescents aged 12 years and over.

08/04/2024 05/03/2024 daridorexant (Quviviq) Full

Treatment of adult patients with insomnia characterised by symptoms present for at least 3 months and considerable impact on daytime functioning.

08/04/2024 TBC mavacamten (Camzyos) Full

For treatment of symptomatic (New York Heart Association, NYHA, class II III) obstructive hypertrophic cardiomyopathy (HOCM) in adult patients.

08/04/2024 TBC tirzepatide (Mounjaro) Full

For treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise

  • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications

  • in addition to other medicinal products for the treatment of diabetes
08/04/2024 TBC dostarlimab (Jemperli) Full

In combination with platinum-containing chemotherapy (PCC) for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer and who are candidates for systemic 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 TBC 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.

TBC TBC voxelotor (Oxbryta) SMC2626 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

TBC TBC linzagolix (Yselty) Full

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

TBC TBC ruxolitinib (Opzelura) Full

For treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age

TBC TBC empagliflozin (Jardiance) Full

In adults for the treatment of chronic kidney disease.

TBC TBC 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.

TBC somapacitan (Sogroya) Abbreviated
Load more