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Drugs

September 2018

Pembrolizumab in addition to chemotherapy for advanced or metastatic urothelial cancer – first line

Pembrolizumab is a drug administered by intravenous infusion which stimulates the body’s own immune system to fight cancer cells. If licensed, pembrolizumab in addition to chemotherapy could provide an additional or alternative treatment option to patients who currently have limited treatment options.

Drugs

September 2018

Pembrolizumab in addition to chemotherapy for locally recurrent, inoperable or metastatic triple-negative breast cancer – first line

Pembrolizumab is a drug administered by intravenous infusion which stimulates the body’s own immune system to fight cancer cells. If licensed, pembrolizumab in addition to chemotherapy could provide an alternative first line treatment option to patients who currently have limited treatment options for locally recurrent or metastatic TNBC not previously treated with chemotherapy.

Drugs

September 2018

Entrectinib for ROS1 fusion positive, locally advanced or metastatic non-small cell lung cancer

Entrectinib is a drug that specifically targets and blocks the ROS1 protein overproduced in many types of cancers including NSCLC. Preclinical trials suggest it may be more potent in targeting ROS1 than the currently approved therapy crizotinib. If licenced entrectinib would provide an additional specific treatment option for patients with ROS rearranged, locally advanced or metastatic NSCLC.

Drugs

September 2018

Ivosidenib for acute myeloid leukaemia with IDH1 mutation

Ivosidenib belongs to a new class of therapies that works by inhibiting the mutated IDH1 enzyme, which in turn reduces the level of d-2-hydroxyglutarate (2-HG), an oncometabolite which impairs myeloid differentiation, increases proliferation of myeloblasts, and blocks cellular differentiation. There are currently no approved treatment options in the EU/UK for those who have relapsed or refractory AML with an IDH1 mutation. If licensed, ivosidenib could be an effective precision medicine for this patient group.

Drugs

September 2018

Givosiran for acute hepatic porphyria (AHP)

Givosiran is made of a short, synthetic strand of genetic material called ‘small interfering RNA’ (siRNA) that has been designed to interfere with the production of an enzyme involved in an early step in making haem. By blocking this early step of haem production in patients with AHP, givosiran is expected to prevent the next steps which produce substances that accumulate in the body and cause the symptoms of the disease.

Drugs

September 2018

Durvalumab in combination with Tremelimumab for recurrent or metastatic squamous cell carcinoma of the head and neck – first line

Cancerous cells produce proteins to stop the body’s natural immune response to recognise and respond to the disease. Durvalumab and tremelimumab are drugs that act in different unique ways to stimulate the body’s natural defences that fight the cancer cells. The combined effect of the two products may produce a stronger and more targeted immune response against the cancer cells when compared to current treatments.

Drugs

September 2018

Bempedoic acid (monotherapy) or bempedoic acid in combination with ezetimibe for primary hypercholesterolaemia or mixed dyslipidaemia

The current standard of care for patients with hypercholesterolaemia is primarily statins which are capable of reducing LDL-C. There is however a subset of patients who are unable to tolerate statins due to adverse effects. Bempedoic acid monotherapy or in combination with ezetimibe are once-daily tablets in development for patients unable to tolerate statins at all, or are not able to tolerate the necessary dose of statin required to reach their LDL-C goal, or are recommended not to use them due to various circumstances. Bempedoic acid and ezetimibe both act in complementary ways to lower LDL-C. These therapies may offer additional and effective treatment options to use in combination with dietary changes and other lipid-modifying therapies to treat primary hypercholesterolaemia or mixed dyslipidaemia.

Drugs

September 2018

Avelumab in combination with axitinib for advanced or metastatic renal cell carcinoma – first line

Avelumab is a human monoclonal antibody that works by inducing cancer cell death and restoring immune response against cancer cells. Axitinib works by blocking the growth of
blood vessels that supply the cancer cells. Their combined mechanism of actions may result in more effective cancer growth inhibition with manageable toxicity profiles. If licensed,
avelumab in combination with axitinib may offer an additional treatment option for people with advanced renal cell carcinoma that have not been treated previously.

Drugs

September 2018

Tagraxofusp for blastic plasmacytoid dendritic cell neoplasm

Tagraxofusp is a fusion protein formed by combining interleukin‐3 (IL‐3) and truncated diphtheria toxin (DT). It causes inactivation of protein synthesis, and death of the target cell.
Treatment for BPDCN has included therapies that are used for AML, acute lymphoblastic leukaemia (ALL), or lymphoma. If licensed, tagraxofusp will offer the first prospectively
studied treatment option for BPDCN for which there are limited treatment options and a significant unmet medical need.

Drugs

September 2018

Atezolizumab in combination with Nab-paclitaxel for unresectable, locally advanced or metastatic triple-negative breast cancer – first line

Atezolizumab combined with nab-paclitaxel is the first product to demonstrate positive phase III immunotherapy results in patients with locally advanced or metastatic TNBC who have not received prior systemic therapy. Atezolizumab is a monoclonal antibody that binds to the programmed cell death 1 ligand (PD-L1) and blocks its interaction with the programmed cell death protein 1 (PD-1), thereby enhancing T-cell activity against tumours. Nab-paclitaxel (paclitaxel formulated as albumin bound nanoparticles) is an anti-microtubule agent that inhibits cell growth by preventing mitosis. The combination may offer a first-line treatment option to improve clinical efficacy in the treatment of people with TNBC, an aggressive disease with no approved targeted therapy.

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