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SMC ID Date Medicine Submission Type Indication
SMC2456 17/01/2022 eculizumab (Soliris)

For treatment of adults with neuromyelitis optica spectrum disorder in patients who are anti-aquaporin-4 antibody-positive with a relapsing course of the disease.

SMC2430 17/01/2022 opicapone (Ongentys) Abbreviated

Adjunctive therapy to preparations of levodopa / DOPA decarboxylase inhibitors in adult patients with Parkinson's disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.

SMC2448 17/01/2022 budesonide (Cortiment) Abbreviated

Induction of remission in patients with active microscopic colitis (MC)

SMC2382 17/01/2022 osimertinib (Tagrisso) Resubmission

As monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.

SMC2403 17/01/2022 tralokinumab (Adtralza) Full

For treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy.

SMC2388 17/01/2022 trastuzumab deruxtecan (Enhertu) Full

As monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive (HER2+) breast cancer who have received two or more prior anti-HER2-based regimens.

SMC2398 17/01/2022 tucatinib (Tukysa) Full

In combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least 2 prior anti-HER2 treatment regimens

SMC2397 17/01/2022 nivolumab (Opdivo) Full

In combination with ipilimumab and 2 cycles of platinum-based doublet chemotherapy (PDC) is indicated for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumours have no sensitising epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) translocations.

SMC2394 13/12/2021 nivolumab (Opdivo) Full

nivolumab with ipilimumab (NIVO+IPI) is indicated for the treatment of adults with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-based combination chemotherapy.

SMC2368 13/12/2021 olaparib (Lynparza) Full

In combination with bevacizumab 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 in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability.

SMC2450 13/12/2021 nitisinone (Orfadin) Non submission

Treatment of adult patients with alkaptonuria (AKU).

SMC2449 13/12/2021 anakinra (Kineret) Non submission

Treatment of Familial Mediterranean Fever (FMF). Kineret should be given in combination with colchicine, if appropriate.

SMC2372 13/12/2021 buprenorphine implant (Sixmo) Full

Substitution treatment for opioid dependence in clinically stable adult patients who require no more than 8 mg/day of sublingual buprenorphine, within a framework of medical, social and psychological treatment.

SMC2395 13/12/2021 tirbanibulin (Klisyri) Full

Field treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis (Olsen grade 1) of the face or scalp in adults.

SMC2426 13/12/2021 tafamidis (Vyndaqel) Resubmission

Treatment of wild type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM).

SMC2387 13/12/2021 ibrutinib (Imbruvica) Full

As a single agent for the treatment of adult patients with Waldenström's macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.

SMC2418 13/12/2021 olopatadine hydrochloride and mometasone furoate monohydrate (Ryaltris) Abbreviated

In adults and adolescents 12 years of age and older for the treatment of moderate to severe nasal symptoms associated with allergic rhinitis

SMC2432 13/12/2021 amikacin (Arikayce) Resubmission

Treatment of non-tuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium Complex (MAC) in adults with limited treatment options who do not have cystic fibrosis.

SMC2434 08/11/2021 durvalumab (Imfinzi) Non submission

Durvalumab in combination with etoposide and either carboplatin or cisplatin for the first-line treatment of adults with extensive-stage small cell lung cancer.

SMC2436 08/11/2021 olaparib (Lynparza) Non submission

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 previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments.

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Publication due date SMC meeting date Medicine Submission Type Indication
07/02/2022 diroximel fumarate (Vumerity) Abbreviated

For treatment of adult patients with relapsing remitting multiple sclerosis (RRMS)

07/02/2022 11/01/2022 nivolumab (Opdivo) Full

In combination with ipilimumab for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).

07/02/2022 11/01/2022 cannabidiol (Epidyolex) Full

As adjunctive therapy of seizures associated with tuberous sclerosis complex (TSC) for patients 2 years of age and older.

07/02/2022 11/01/2022 pemigatinib (Pemazyre) Full

As monotherapy for the treatment of adults with locally advanced or metastatic cholangiocarcinoma (CCA) with a fibroblast growth factor receptor 2 (FGFR2) gene fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

07/02/2022 11/01/2022 enzalutamide (Xtandi) Full

For treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy.

07/02/2022 11/01/2022 risdiplam (Everysdi) Full

For the treatment of 5q spinal muscular atrophy (SMA) in patients two months of age and older, with a clinical diagnosis of SMA type 1, type 2 or type 3 or with one to four SMN2 copies.

07/02/2022 11/01/2022 cenobamate (Ontozry) Full

For the adjunctive treatment of focal onset seizures (FOS) with or without secondary generalisation in adult patients with epilepsy who have not been adequately controlled despite treatment with at least two anti-epileptic products.

07/03/2022 07/12/2021 dostarlimab (Jemperli) Full

Monotherapy for the treatment of adult patients with recurrent or advanced mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) endometrial cancer (EC) that has progressed on or following prior treatment with a platinum‑containing regimen.

14/03/2022 01/02/2022 berotralstat (Orladeyo) Full

Routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older.

14/03/2022 01/02/2022 hydrocortisone modified-release hard capsules (Efmody) Full

For treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults

14/03/2022 01/02/2022 sotorasib (Lumykras) Full

As monotherapy for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), who have progressed on, or are intolerant to, platinum-based chemotherapy and/or anti PD-1/PD-L1 immunotheray

14/03/2022 01/02/2022 sacituzumab govitecan (Trodelvy) Full

Treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior lines of systemic therapies, at least one of them given for unresectable locally advanced or metastatic disease.

14/03/2022 01/02/2022 solriamfetol (Sunosi) Full

To improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA) whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure (CPAP).

11/04/2022 01/03/2022 potassium citrate/potassium hydrogen carbonate (Sibnayal) Full

For treatment of distal renal tubular acidosis (dRTA) in adults, adolescents and children aged one year and older

11/04/2022 01/03/2022 venetoclax (Venclyxto) Full

In combination with a hypomethylating agent (HMA) for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy (IC).

11/04/2022 01/03/2022 odevixibat (Bylvay) Ultra-orphan initial assessment

For treatment of progressive familial intrahepatic cholestasis (PFIC) in patients aged 6 months or older

TBC 02/10/2018 padeliporfin (TOOKAD) Full Indicated as monotherapy for adult patients with previously untreated, unilateral, low-risk, adenocarcinoma of the prostate with a life expectancy ≥ 10 years and: - Clinical stage T1c or T2a, - Gleason Score ≤ 6, based on high-resolution biopsy strategies, - PSA ≤ 10 ng/mL, - 3 positive cancer cores with a maximum cancer core length of 5 mm in any one core or 1-2 positive cancer cores with ≥ 50 % cancer involvement in any one core or a PSA density ≥ 0.15 ng/mL/cm3.
TBC TBC buprenorphine and naloxone (Zubsolv) Abbreviated Substitution treatment for opioid drug dependence.
TBC oritavancin (Orbactiv) Full

For the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults.

TBC beclometasone dipropionate/formoterol fumarate dehydrate/glycopyrronium bromide (Trimbow) Abbreviated

Maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and high dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year.

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