SMC2726
|
07/10/2024
|
nivolumab (Opdivo)
|
Non submission
|
In combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.
|
|
SMC2725
|
07/10/2024
|
drospirenone (Slynd)
|
Non submission
|
Contraception
|
|
SMC2724
|
07/10/2024
|
cemiplimab (Libtayo)
|
Non submission
|
In combination with platinum‐based chemotherapy is indicated for the first‐line treatment of adult patients with NSCLC expressing PD-L1 (in ≥ 1% of tumour cells), with no EGFR, ALK or ROS1 aberrations, who have: - locally advanced NSCLC who are not candidates for definitive chemoradiation, or - metastatic NSCLC
|
|
SMC2685
|
07/10/2024
|
faricimab (Vabysmo)
|
Abbreviated
|
For the treatment of adult patients with visual impairment due to macular oedema secondary to branched and central retinal vein occlusion (BRVO and CRVO).
|
|
SMC2678
|
07/10/2024
|
relugolix (Orgovyx)
|
Full
|
- For the treatment of adult patients with advanced hormone-sensitive prostate cancer. - For the 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.
|
|
SMC2674
|
07/10/2024
|
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.
|
|
SMC2689
|
07/10/2024
|
pembrolizumab (Keytruda)
|
Full
|
As monotherapy for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum‑based chemotherapy.
|
|
SMC2673
|
07/10/2024
|
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.
|
|
SMC2659
|
07/10/2024
|
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.
|
|
SMC2717
|
09/09/2024
|
zilucoplan (Zilbrysq)
|
Non submission
|
As an adjunct to diet in adult patients with genetically confirmed familial chylomicronaemia syndrome (FCS) and at high risk for pancreatitis, in whom response to diet and triglyceride lowering therapy has been inadequate.
|
|
SMC2715
|
09/09/2024
|
pegcetacoplan (Aspaveli)
|
Non submission
|
As monotherapy in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have haemolytic anaemia.
|
|
SMC2716
|
09/09/2024
|
volanesorsen (Waylivra)
|
Non submission
|
As an adjunct to diet in adult patients with genetically confirmed familial chylomicronaemia syndrome (FCS) and at high risk for pancreatitis, in whom response to diet and triglyceride lowering therapy has been inadequate.
|
|
SMC2664
|
09/09/2024
|
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.
|
|
SMC2669
|
09/09/2024
|
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.
|
|
SMC2667
|
09/09/2024
|
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.
|
|
SMC2668
|
09/09/2024
|
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.
|
|
SMC2649
|
12/08/2024
|
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.
|
|
SMC2654
|
12/08/2024
|
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.
|
|
SMC2702
|
12/08/2024
|
fezolinetant (Veoza)
|
Non submission
|
Treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.
|
|
SMC2704
|
12/08/2024
|
nivolumab (Opdivo)
|
Non submission
|
Adjuvant treatment of adults and adolescents 12 years of age and older with Stage IIB or IIC melanoma.
|
|