National Institute for Health and Care Excellence (NICE)

AstraZeneca has announced that the National Institute for Health and Care Excellence (NICE) has recommended Imfinzi (durvalumab) in combination with gemcitabine and cisplatin (chemotherapy) for NHS use in England and Wales for the first-line treatment of adults with locally advanced, unresectable, or metastatic biliary tract cancer (BTC).1 There remains a significant unmet need for new […]

Chiesi’s Lamzede (velmanase alfa) will now be funded on the NHS in England and Wales as an option for treating the non-neurological signs and symptoms of mild to moderate alpha-mannosidosis following a recommendation by the National Institute for Health and Care Excellence (NICE). The treatment must be started in people under 18 years of age, […]

The National Institute for Health and Care Excellence (NICE) has recommended Darzalex (daratumumab) in combination with lenalidomide and dexamethasone (DLd) for untreated multiple myeloma (MM) for routine use on the NHS in England and Wales. The therapy is now recommended within an NHS setting for the treatment of adults with newly diagnosed MM where an […]

The UK’s National Institute for Health and Care Excellence (NICE) has recommended Elfabrio (pegunigalsidase alfa) as an option for treating Fabry disease (or alpha-galactosidase deficiency). The drug is recommended for use on the NHS under the terms of a confidential commercial agreement. Pegunigalsidase alfa is a novel enzyme replacement therapy (ERT) administered via intravenous infusion […]

In a draft guidance consultation, the UK National Institute for Health and Care Excellence (NICE) has decided not to recommend the use of Hemgenix (etranacogene dezaparvovec) on the NHS for treating haemophilia B (congenital factor IX deficiency). Although the gene therapy was granted a marketing authorisation by the UK Medicines and Healthcare products Regulatory Agency […]

The latest episode of the DDW Highlights podcast is now available to listen to below. DDW’s Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates.  Regulatory approvals and industry guidelines are key to the continued development and discovery of drugs, which is a common theme throughout this week’s […]

News round-up for 5-9 June by DDW Multimedia Editor Megan Thomas.  Regulatory approvals and industry guidelines are key to the continued development and discovery of drugs, which is a common theme throughout this week’s news highlights, including an FDA approval for Pfizer, a NICE recommendation for AstraZeneca UK, and an update to the HER2 Breast […]

AstraZeneca UK announced that Lynparza (olaparib) is recommended by the National Institute for Health and Care Excellence (NICE) for maintenance treatment of BRCA-mutated relapsed, platinum-sensitive, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer in adults who have had two or more courses of platinum-based chemotherapy.  BRCA1 and BRCA2 are human genes that produce proteins […]

The UK’s National Institute for Health and Care Excellence (NICE) has recommended additional uses for two CAR-T therapies from Gilead Sciences/Kite, as part of the Cancer Drugs Fund (CDF). Yescarta (axicabtagene ciloleucel: axi-cel) has been recommended by NICE for the treatment of eligible adult patients with diffuse large B cell lymphoma (DLBCL) and high-grade B-cell […]

The National Institute for Health and Care Excellence (NICE) has approved a combination of Imbruvica (ibrutinib) and venetoclax for all untreated chronic lymphocytic leukaemia (CLL) patients in England. The oral, fixed-duration combination treatment for adult CLL patients has been approved as first-line therapy and has been shown to be more effective than existing treatments. NICE’s […]

The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending AstraZeneca’s Tezspire (tezepelumab).  The drug is approved for use within NHS England and NHS Wales and as add-on maintenance therapy in adult and adolescent patients, 12 years and older, with severe asthma who are inadequately controlled with high dose inhaled […]

The UK’s National Institute for Health and Clinical Excellence (NICE) has recommended that Lynparza (olaparib) can be used for NHS patients with both early-stage breast cancer and prostate cancer. Olaparib is PARP inhibitor that targets cancers linked to faulty BRCA1 or BRCA2 genes and works across many different cancer types. The recommendation will grant patients in […]

The National Institute for Health and Care Excellence (NICE) has published its Final Guidance recommending Translarna (ataluren) for reimbursement and use across the National Health Service (NHS) in England and Wales.   Translarna is the only approved treatment for patients with nonsense mutation Duchenne muscular dystrophy aged two years and older who can walk.  The final […]

Hundreds of people with an aggressive form of lymphoma are set to benefit from the first personalised immunotherapy treatment to be recommended for routine use in the NHS.  Axicabtagene ciloleucel (Yescarta, Kite) is a CAR-T therapy for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) who […]

NICE has recommended Ninlaro (ixazomib) with lenalidomide and dexamethasone as an option relapsed or refractory multiple myeloma (RRMM) in adults who have received two or three lines of therapy.  Since its launch in December 2017, ixazomib has been funded through the Cancer Drugs Fund and has been used to treat over 4,000 patients in England.    […]

The latest episode of the DDW Highlights podcast is now available to listen to below. DDW’s Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry news.  Gene therapies have made the headlines over the last week, with treatments for rare AADC deficiency, lung cancer and haemophilia B given […]