Arsenic trioxide

• Solution for infusion ampoules 10mg/10ml

Notes

1. NICE TA526: Arsenic trioxide (Trisenox) is recommended, within its marketing authorisation, as an option for inducing remission and consolidation in acute promyelocytic leukaemia (characterised by the presence of the t[15;17] translocation or the PML/RAR-alpha gene) in adults, only when the criteria of the NICE TA are met (June 2018).

Asparaginase

• Powder for solution for infusion vials 10,000unit

Atidarsagene autotemcel

• Dispersion for infusion bags 2million-10million cells/ml

Notes

1. NICE HST18: Atidarsagene autotemcel (Libmeldy) is recommended, within its marketing authorisation, as an option for treating metachromatic leukodystrophy with mutations in the arylsulphatase A (ARSA) gene (March 2022):
   1. for children who have late infantile or early juvenile types, with no clinical signs or symptoms
   2. for children who have the early juvenile type, with early clinical signs or symptoms, and who can still walk independently and have no cognitive decline.
   3. It is recommended only if the company provides atidarsagene autotemcel according to the commercial arrangement.
   4. Atidarsagene autotemcel should be delivered in a highly specialised service by a specialist multidisciplinary team.

Axicabtagene ciloleucel

• Dispersion for infusion bags 40million-200million cells/68ml

Notes

1. NICE TA872: Axicabtagene ciloleucel therapy (Yescarta) is recommended ​, within its marketing authorisation, as an option for treating relapsed or refractory diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma in adults after 2 or more systemic therapies, only if the company provides it according to the commercial arrangement (February 2023).
2. NICE TA895: Axicabtagene ciloleucel for treating relapsed or refractory diffuse large B-cell lymphoma after first-line chemoimmunotherapy (June 2023):
   1. Axicabtagene ciloleucel (​Yescarta​) ​is recommended​ for use within the Cancer Drugs Fund as an option for treating diffuse large B-cell lymphoma in adults when an autologous stem cell transplant is suitable if it:
      1. has relapsed within 12 months after first-line chemoimmunotherapy ​or​
      2. is refractory to first-line chemoimmunotherapy.
   2. It is recommended only if the conditions in the managed access agreement for axicabtagene ciloleucel are followed.
3. NICE TA894: Axicabtagene ciloleucel (​Yescarta​) ​is ​not recommended​, within its marketing authorisation, for treating relapsed or refractory follicular lymphoma after 3 or more systemic treatments in adults (June 2023).

Bacillus Calmette-Guérin

• OncoTICE bladder instillation 12.5mg vial
• ImmuCyst bladder instillation 81mg vial

Belzutifan

• Tablets 40mg

Notes

1. NICE TA1011: Belzutifan (Welireg) is recommended with managed access as an option for treating von Hippel-Lindau (VHL) disease in adults:
   1. who need treatment for VHL-associated renal cell carcinomas, central nervous system hemangioblastomas or pancreatic neuroendocrine tumours, and
   2. when localised procedures are unsuitable or undesirable.
   3. It is only recommended if the conditions in the managed access agreement for belzutifan are followed (October 2024).

Blinatumomab

• Powder for solution for infusion vials 38.5micrograms

Notes

1. NICE TA450: Blinatumomab (Blincyto) is recommended within its marketing authorisation as an option for treating Philadelphia-chromosome-negative relapsed or refractory precursor B-cell acute lymphoblastic leukaemia in adults, only if the company provides it with the discount agreed in the patient access scheme (June 2017).
2. NICE TA589: Blinatumomab (Blincyto) is recommended as an option for treating Philadelphia-chromosome-negative CD19‑positive B‑precursor acute lymphoblastic leukaemia in adults with minimal residual disease (MRD) of at least 0.1% (July 2019), only if:
   1. the disease is in first complete remission and
   2. the company provides blinatumomab according to the commercial arrangement.

Brexucabtagene autoleucel

(Autologous anti-CD19-transduced CD3+ cells)

• Dispersion for infusion bags 40million-200million cells/68ml

Notes

1. NICE TA677: Brexucabtagene autoleucel (Tecartus) is recommended for use within the Cancer Drugs Fund as an option for relapsed or refractory mantle cell lymphoma in adults who have previously had a Bruton's tyrosine kinase (BTK) inhibitor. It is only recommended if the conditions in the managed access agreement for brexucabtagene autoleucel treatment are followed (February 2021).
2. NICE TA893: Brexucabtagene autoleucel (​Tecartus​) ​is recommended​ for use within the Cancer Drugs Fund as an option for treating relapsed or refractory B-cell acute lymphoblastic leukaemia in people 26 years and over, only if the conditions in the managed access agreement are followed (June 2023).

Caplacizumab

• Powder and solvent for solution for injection vials 10mg

Notes

1. NICE TA667: Caplacizumab (Cablivi) with plasma exchange and immunosuppression is recommended, within its marketing authorisation, as an option for treating an acute episode of acquired thrombotic thrombocytopenic purpura (TTP) in adults, and in young people aged 12 years and over who weigh at least 40kg (December 2020).
   1. Treatment should be started and supervised by physicians experienced in managing thrombotic microangiopathies. It is recommended only if the company provides caplacizumab according to the commercial arrangement.

Crisantaspase

(Erwinia chrysanthemi)

• Erwinase powder for solution for injection vials 10,000unit

Dinutuximab beta

• Solution for infusion vials 20mg/4.5ml

Notes

1. NICE TA538: Dinutuximab beta (Qarziba) is recommended as an option for treating high-risk neuroblastoma in people aged 12 months and over whose disease has at least partially responded to induction chemotherapy, followed by myeloablative therapy and stem cell transplant (August 2018), only if:
   1. they have not already had anti-GD2 immunotherapy and
   2. the company provides dinutuximab beta according to the commercial arrangement.

Ivosidenib

• Tablets 250mg

Notes

1. NICE TA948: Ivosidenib (Tibsovo) is recommended, within its marketing authorisation, as an option for treating locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation in adults after 1 or more systemic treatments, only if the company provides it according to the commercial arrangement (January 2024).
2. NICE TA979: Ivosidenib (Tibsovo) plus azacitidine is recommended, within its marketing authorisation, as an option for untreated acute myeloid leukaemia (AML) with an IDH1 R132 mutation in adults who cannot have standard intensive induction chemotherapy, only if the company provides it according to the commercial arrangement (June 2024).
   

Mogamulizumab

• Solution for infusion vials 20mg/5ml

Notes

1. NICE TA754: Mogamulizumab for previously treated mycosis fungoides and Sézary syndrome (December 2021)
   1. Mogamulizumab (Poteligeo) is recommended, within its marketing authorisation, as an option for treating Sézary syndrome in adults who have had at least 1 systemic treatment.
      • It is recommended only if the company provides mogamulizumab according to the commercial arrangement.
   2. Mogamulizumab (Poteligeo) is recommended as an option for treating mycosis fungoides in adults, only if:
      • their condition is stage 2B or above and
      • they have had at least 2 systemic treatments and
      • the company provides mogamulizumab according to the commercial arrangement.

Pegaspargase

• Powder for solution for injection vials 3,750units

Notes

1. NICE TA408: Pegaspargase (Oncaspar), as part of antineoplastic combination therapy, is recommended as an option for treating acute lymphoblastic leukaemia in children, young people and adults only when they have untreated newly diagnosed disease (September 2016).

Polatuzumab vedotin

• Powder for concentrate for solution for infusion vials 30mg, 140mg

Notes

1. NICE TA649: Polatuzumab vedotin (Polivy) with rituximab and bendamustine is recommended, within its marketing authorisation, as an option for treating relapsed or refractory diffuse large B-cell lymphoma in adults who cannot have a haematopoietic stem cell transplant. It is recommended only if the company provides polatuzumab vedotin according to the commercial arrangement (September 2020).
2. NICE TA874: Polatuzumab vedotin (​Polivy​) with rituximab, cyclophosphamide, doxorubicin and prednisolone (R-CHP) ​is recommended​ for untreated diffuse large B-cell lymphoma (DLBCL) in adults (March 2023), only if:
   1. they have an International Prognostic Index (IPI) score of 2 to 5
   2. the company provides it according to the commercial arrangement.

Procarbazine

• Capsules 50mg

Selinexor

• Tablets 20mg

Notes

1. NICE TA970: Selinexor (Nexpovio) plus dexamethasone is recommended, within its marketing authorisation, for treating multiple myeloma in adults (May 2024) when:
   1. they have had 4 or more treatments, and
   2. the condition is refractory to at least 2 proteasome inhibitors, 2 immunomodulatory agents and and anti-CD38 monoclonal antibody (penta-refractory), and
   3. the condition has progressed on the last treatment, and
   4. the company provides it according to the commercial arrangement.
2. NICE TA974: Selinexor (Nexpovio) plus bortezomib and dexamethasone is recommended as an option for treating multiple myeloma in adults (May 2024), only if:
   1. they have only had 1 previous line of treatment, and their condition is refractory to both daratumumab and lenalidomide or
   2. they have only had 2 previous lines of treatment and their condition is refractory to lenalidomide, and
   3. the company provides it according to the commercial arrangement.

Sotorasib

• Tablets 120mg

Notes

1. NICE TA781: Sotorasib (Lumykras) is recommended for use within the Cancer Drugs Fund as an option for treating KRAS G12C mutation-positive locally advanced or metastatic non-small-cell lung cancer in adults whose disease has progressed on, or who cannot tolerate, platinum-based chemotherapy or anti-PD-1/PD-L1 immunotherapy (March 2022).
   1. It is recommended only if the conditions in the managed access agreement for sotorasib are followed.

Talimogene laherparepvec

• Solution for injection vials 1million plaque forming units/1ml, 100million plaque forming units/1ml

Notes

1. NICE TA410: Talimogene laherparepvec (Imlygic) is recommended, in adults, as an option for treating unresectable, regionally or distantly metastatic (Stage 3B, 3C or 4M1a) melanoma that has not spread to bone, brain, lung or other internal organs (September 2016), only if:
   1. treatment with systemically administered immunotherapies is not considered the best option by a multidisciplinary team and
   2. the company provides talimogene laherparepvec with the discount agreed in the patient access scheme.

Tisagenlecleucel

• Dispersion for infusion bags 1.2million-600million cells

Notes

1. NICE TA975: Tisagenlecleucel (Kymriah) is recommended, within its marketing authorisation, as an option for people 25 years and under for treating B-cell acute lymphoblastic leukaemia (May 2024) that is:
   1. relapsed after a transplant or
   2. relapsed for a second or later time or
   3. refractory, and
   4. only if the company provides it according to the commercial arrangement.

Venetoclax

• Tablets 10mg, 50mg, 100mg

Notes

1. NICE TA561: Venetoclax (Venclyxto) with rituximab is recommended, within its marketing authorisation, as an option for treating chronic lymphocytic leukaemia in adults who have had at least 1 previous therapy. It is recommended only if the company provides it according to the commercial arrangement (February 2019).
2. NICE TA663: Venetoclax with obinutuzumab for untreated chronic lymphocytic leukaemia (December 2020):
   1. Venetoclax (Venclyxto) plus obinutuzumab is recommended as an option for untreated chronic lymphocytic leukaemia (CLL) in adults, only if:
      • there is a 17p deletion or TP53 mutation, or
      • there is no 17p deletion or TP53 mutation, and fludarabine plus cyclophosphamide and rituximab (FCR), or bendamustine plus rituximab (BR), is unsuitable, and
      • the companies provide the drugs according to the commercial arrangements.
   2. Venetoclax (Venclyxto) plus obinutuzumab is recommended for use within the Cancer Drugs Fund as an option for untreated CLL in adults, only if:
      • there is no 17p deletion or TP53 mutation, and FCR or BR is suitable, and
      • the conditions in the managed access agreement for venetoclax plus obinutuzumab are followed.
3. NICE TA796: Venetoclax (Venclyxto) monotherapy is recommended, within its marketing authorisation, for treating chronic lymphocytic leukaemia (CLL) in adults (June 2022):
   1. with a 17p deletion or TP53 mutation and when a B cell receptor pathway inhibitor is unsuitable, or whose disease has progressed after a B cell receptor pathway inhibitor or
   2. without a 17p deletion or TP53 mutation, and whose disease has progressed after both chemo immunotherapy and a B cell receptor pathway inhibitor.
   3. It is recommended only if the company provides venetoclax according to the commercial arrangement.
4. NICE TA765: Venetoclax (Venclyxto) with azacitidine is recommended, within its marketing authorisation, as an option for untreated acute myeloid leukaemia in adults when intensive chemotherapy is unsuitable. It is recommended only if the company provides venetoclax according to the commercial arrangement (February 2022).
5. NICE TA787: Venetoclax (Venclyxto) with low dose cytarabine is recommended as an option for untreated acute myeloid leukaemia in adults when intensive chemotherapy is unsuitable (April 2022), only if:
   1. they have over 30% bone marrow blasts
   2. the company provides venetoclax according to the commercial arrangement.
6. MHRA Drug Safety Update (December 2021): Venetoclax (Venclyxto): updated recommendations on tumour lysis syndrome (TLS)
   1. Tumour lysis syndrome (TLS) is a known risk of venetoclax; fatal cases have been reported, with some occurring in patients with chronic lymphocytic leukaemia receiving a single dose of venetoclax 20 milligrams (the lowest dose used in the dose-titration phase) and in patients with low-to-medium TLS risk.
   2. For all patients prescribed venetoclax, perform TLS risk assessment and adhere to guidance on appropriate prophylactic measures (including hydration and antihyperuricaemics), laboratory monitoring (including blood chemistries), dose titration, and drug interactions. Refer to the Summary of Product Characteristics for the full specific advice for each indication.
   3. Advise patients about TLS and measures to reduce the risk, discuss the symptoms of TLS, and provide the Patient Information Leaflet and the patient card (for patients with chronic lymphocytic leukaemia).
   4. For advice to give to patients and carers, see the safety update here.

Amivantamab

• NICE TA850: Amivantamab (Rybrevant) is not recommended, within its marketing authorisation, for treating locally advanced or metastatic non-small-cell lung cancer (NSCLC) after platinum-based chemotherapy in adults whose tumours have epidermal growth factor receptor (EGFR) exon 20 insertion mutations (December 2022).