Bendamustine hydrochloride

• Powder for solution for infusion vials 25mg, 100mg

Notes

1. NICE TA216: Bendamustine is recommended as an option for the first-line treatment of chronic lymphocytic leukaemia (Binet stage B or C) in patients for whom fludarabine combination chemotherapy is not appropriate (February 2011).
2. NICE TA629: Obinutuzumab (Gazyvaro) with bendamustine followed by obinutuzumab maintenance is recommended, within its marketing authorisation, as an option for treating follicular lymphoma that did not respond or progressed up to 6 months after treatment with rituximab or a rituximab-containing regimen (May 2020).
   1. It is recommended only if the company provides it according to the commercial arrangement.
3. MHRA Drug Safety Update (July 2017) Bendamustine (Levact): increased mortality observed in recent clinical studies in off-label use; monitor for opportunistic infections, hepatitis B reactivation.
4. MHRA Drug Safety Update (March 2021): Bendamustine (Levact): increased risk of non-melanoma skin cancer and progressive multifocal encephalopathy (PML).
   1. Periodically perform skin examinations in patients on bendamustine-containing regimens.
   2. Consider PML in the differential diagnosis for patients on bendamustine with new or worsening neurological, cognitive, or behavioural signs or symptoms.

Busulfan

• Tablets 2mg
• Solution for infusion vials 60mg/10ml

Carmustine

• Implant 7.7mg
• BiCNU powder and solvent for infusion vials 100mg (unlicensed preparation)

Notes

1. NICE TA121: Carmustine implants (Gliadel) and temozolomide for the treatment of newly diagnosed high-grade glioma (June 2007):
   1. Carmustine implants, within their licensed indications, are recommended as an option for the treatment of newly diagnosed high-grade glioma only for patients in whom 90% or more of the tumour has been resected.
      1. Refer to TA121 for additional service provider requirements.
   2. Carmustine implants are not recommended for the treatment of newly diagnosed high-grade glioma for patients in whom less than 90% of the tumour has been resected.

Chlorambucil

• Tablets 2mg

Notes

1. NICE TA343: Obinutuzumab (Gazyvaro), in combination with chlorambucil is recommended as an option for adults with untreated chronic lymphocytic leukaemia who have comorbidities that make full‑dose fludarabine‑based therapy unsuitable for them (June 2015), only if:
   1. bendamustine‑based therapy is not suitable and
   2. the company provides obinutuzumab with the discount agreed in the patient access scheme.

Chlormethine

• Gel 160micrograms/g

Notes

1. NICE TA720: Chlormethine gel (Ledaga) is recommended as an option for treating early stage (stage 1A, 1B, and 2A) mycosis fungoides-type cutaneous T‑cell lymphoma (MF‑CTCL) in adults, only if the company provides chlormethine gel according to the commercial arrangement (August 2021).

Cyclophosphamide

• Tablets 50mg
• Powder for solution for injection vials 500mg, 1g

Dacarbazine

• Powder for solution for injection vials 100mg, 200mg
• Powder for solution for infusion vials 500mg, 1g

Ifosfamide

• Powder for solution for injection vials 1g, 2g

Lomustine

• Capsules 40mg

Melphalan

• Tablets 2mg
• Powder and solvent for solution for injection vials 50mg

Streptozocin

• Powder for solution for infusion vials 1g

Temozolomide

• Capsules 5mg, 20mg, 100mg, 140mg, 180mg, 250mg

Notes

1. NICE TA23: Temozolomide (Temodal) is recommended as an option for treating malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy only if the person has a Karnofsky performance status score greater than or equal to 70 and a life expectancy of 12 weeks or more (March 2016).
   1. Refer to TA23 for additional considerations regarding performance status score.
2. NICE TA121: Carmustine implants and temozolomide (Temodal) for the treatment of newly diagnosed high grade glioma (June 2007):
   1. Temozolomide (Temodal), within its licensed indications, is recommended as an option for the treatment of newly diagnosed glioblastoma multiforme (GBM) in patients with a World Health Organization (WHO) performance status of 0 or 1.
3. MHRA Drug Safety Update (January 2014): Temozolomide: risk of hepatic injury, including fatal hepatic failure—updated warnings and monitoring guidance
   1. Baseline LFTs should be done before starting temozolomide treatment. If these tests are abnormal, physicians should consider the balance of benefits and risks when deciding whether to start treatment
   2. Patients on a 42-day treatment cycle should have LFTs repeated midway through this cycle. All patients should have LFTs checked after every treatment cycle
   3. If a patient develops significantly abnormal LFTs, the benefits of continuing treatment should be carefully considered versus the risk of potentially severe liver toxicity
   4. Note that liver toxicity may occur several weeks or more after initiation of treatment or after the last treatment with temozolomide.

Thiotepa

• Powder for solution for infusion vials 15mg, 100mg

Trabectedin

• Powder for solution for infusion vials 250microgram, 1mg

Notes

1. NICE TA185: Trabectedin (Yondelis) is recommended as a treatment option for people with advanced soft tissue sarcoma (February 2010), if:
   1. treatment with anthracyclines and ifosfamide has failed or
   2. they are intolerant of or have contraindications for treatment with anthracyclines and ifosfamide
   3. Trabectedin is only recommended if the company provides it according to the commercial arrangement.
2. NICE TA389: Topotecan, pegylated liposomal doxorubicin hydrochloride (Caelyx), paclitaxel, trabectedin (Yondelis) and gemcitabine for treating recurrent ovarian cancer (April 2016):
   1. Trabectedin (Yondelis) in combination with PLDH is not recommended for treating the first recurrence of platinum sensitive ovarian cancer.

Treosulfan

• Capsules 250mg
• Powder for solution for injection vials 1g, 5g
• Powder for solution for infusion vials 1g, 5g

Notes

1. NICE TA640: Treosulfan (Trecondi) with fludarabine is recommended as an option for conditioning treatment before allogeneic haematopoietic stem cell transplant (allo-HSCT) for people with malignant diseases for whom a reduced intensity regimen, such as low-dose busulfan with fludarabine, would be suitable (August 2020).