Cancer and MS drugs approved in Scotland
pharmafile | December 9, 2015 | News story | Sales and Marketing | Celgene, Copaxone, Novartis, SMC, Scottish Medicines Consortium, Tevaq, ceritinib, glatiramer acetate, lenalidomide, lung cancer, multiple myeloma, multiple sclerosis, revlimis, zykadia
The Scottish Medicines Consortium (SMC) has approved three new treatments for lung cancer, multiple sclerosis and multiple myeloma, from Novartis, Teva and Celgene respectively.
Novartis’ Zykadia (ceritinib) is now recommended for us in the NHS in Scotland for adults with anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC), who have previously been treated with the ALK inhibitor Xalkori (crizotinib).
Zykadia is the first and only targeted therapy currently licensed for lung cancer patients whose disease has progressed whilst being treated with Xalkori. The SMC decision means that patients with this rare sub-type of lung cancer in Scotland will have access to another treatment option that specifically targets the genetic make-up of their disease.
Lung cancer is the most common cause of cancer death in the UK, accounting for 22% of all cancer deaths – more than breast, prostate, bladder cancer and leukaemia combined. Lung cancer rates in Scotland are particularly high relative to other countries, with over 5,000 new cases and in excess of 4,000 deaths reported each year in a total population of around 5.3 million.
The Scottish approval highlights the increasing number of cancer therapies available in one of the devolved UK nations that are unavailable in England and Wales. NICE has rejected Zykadia for use on the NHS due to uncertainty of its benefits.
The Scottish regulator also approved Teva’s multiple sclerosis (MS) treatment, Copaxone (glatiramer acetate), based on information showing that the new formulation of Copaxone, given three times a week, costs the same as the currently available daily formulation.
Teva’s Phase III Glatiramer Acetate Low-Frequency Administration (GALA) study of over 1,400 people with MS, found those who took the treatment three-times weekly with experienced significantly lower relapse rates compared to people who had a placebo treatment after 12 months, and with 57% fewer injections.
In addition, the SMC green-lighted Celgene’s Revlimid (lenalidomide), in combination with dexamethasone, for patients newly diagnosed with multiple myeloma (MM), who are not eligible for stem cell transplant and who are unsuitable for thalidomide-containing regimens.
The FIRST trial, MM-020, published last year in the New England Journal of Medicine, demonstrated that the time people lived without their tumour getting worse (progression-free survival, of PFS) was significantly better in people treated continuously with Revlimid plus dexamethasone (Rd), compared with those receiving melphalan-prednisone-thalidomide (MPT).
The median PFS was 26.0 months with Rd, compared to 21.0 months with MPT. The average survival in patients receiving Rd continuous therapy was 58.9 months, compared to 48.5 months for patients treated with MPT
Commenting on the news, Eric Low, chief executive of Myeloma UK, says: “This is great news for myeloma patients in Scotland. I commend the efforts of the SMC and Celgene for working together to ensure the availability of lenalidomide for newly diagnosed myeloma patients in Scotland. We will now focus our efforts on ensuring lenalidomide is approved in the other parts of the UK; it is imperative that there is fair and equal access to effective treatments across the whole of the UK, irrespective of where you live.’’
Joel Levy
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