|
SMC2881
|
07/09/2026
|
epcoritamab (Tepkinly)
|
Full
|
Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
|
|
|
SMC2972
|
07/09/2026
|
lisocabtagene (Breyanzi)
|
Non submission
|
Treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), after two or more lines of systemic therapy.
|
|
|
SMC2867
|
07/09/2026
|
lorlatinib (Lorviqua)
|
Reassessment
|
As monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor or whose disease has progressed after prior treatment with an ALK inhibitor.
|
|
|
SMC2846
|
13/07/2026
|
glofitamab (Columvi)
|
Full
|
In combination with gemcitabine and oxaliplatin is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS) who are ineligible for autologous stem cell transplant (ASCT).
|
|
|
SMC2943
|
08/06/2026
|
tafasitamab (Minjuvi)
|
Non submission
|
Tafasitamab is indicated in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one line of systemic therapy.
|
|
|
SMC2925
|
11/05/2026
|
brentuximab (Adcetris)
|
Non submission
|
Adult patients with previously untreated CD30+ Stage IIB with risk factors, Stage III or Stage IV HL in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine, dexamethasone (BrECADD).
|
|
|
SMC2897
|
19/01/2026
|
pirtobrutinib (Jaypirca)
|
Non submission
|
As monotherapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have been previously treated with a Bruton's tyrosine kinase (BTK) inhibitor
|
|
|
SMC2762
|
11/08/2025
|
brentuximab vedotin (Adcetris)
|
Full
|
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).
|
|
|
SMC2819
|
11/08/2025
|
zanubrutinib (Brukinsa)
|
Abbreviated
|
As monotherapy for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy
|
|
|
SMC2749
|
07/04/2025
|
alectinib hydrochloride (Alecensa)
|
Full
|
Monotherapy as adjuvant treatment for adult patients with Stage IB (tumours ≥ 4cm) to IIIA (7th edition of the UICC/AJCC-staging system) anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) following complete tumour resection.
|
|
|
SMC2684
|
09/12/2024
|
zanubrutinib (Brukinsa)
|
Full
|
As monotherapy is indicated for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy.
|
|
|
SMC2695
|
11/11/2024
|
axicabtagene ciloleucel (Yescarta)
|
Resubmission
|
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.
|
|
|
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.
|
|
|
SMC2671
|
13/05/2024
|
zanubrutinib (Brukinsa)
|
Non submission
|
In combination with obinutuzumab for the treatment of adult patients with refractory or relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.
|
|
|
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.
|
|
|
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.
|
|
|
SMC2621
|
11/09/2023
|
crizotinib (Xalkori)
|
Non submission
|
As monotherapy for the treatment of paediatric patients (age ≥6 to <18 years) with:
- relapsed or refractory systemic anaplastic lymphoma kinase (ALK) positive anaplastic large cell lymphoma (ALCL)
- recurrent or refractory anaplastic lymphoma kinase (ALK) positive unresectable inflammatory myofibroblastic tumour (IMT)
|
|
|
SMC2542
|
11/09/2023
|
mosunetuzumab (Lunsumio)
|
Full
|
As monotherapy for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior systemic therapies.
|
|
|
SMC2524
|
10/07/2023
|
polatuzumab vedotin (Polivy)
|
Reassessment
|
In combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who are not candidates for haematopoietic stem cell transplant.
|
|