EMA gives positive opinion for Keytruda combination

EMA has decided on a positive opinion for a new combo of MSD’s cancer blockbuster, Keytruda (pembrolizumab) and Inlyta (axitinib). The organisation’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of the anti-PD-1 therapy and Inlyta combo, a tyrosine kinase inhibitor, for the first-line treatment of patients with advanced

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NICE presents long anticipated review of methodologies

NICE has unveiled a long-awaited review of its health technology evaluation methodologies, although a re-think on its core ‘QALY threshold’ approach won’t be included. England’s cost effectiveness watchdog recently celebrated its 20th anniversary and has often had a fractious relationship with the pharma industry over those years, especially when drugs have been rejected because of

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Novartis Breast Cancer Treatment gains NICE Recommendation

Novartis announces Ribociclib has been recommended by the NICE for use on the NHS in combination with fulvestrant, where exemestane plus everolimus is the most appropriate alternative, for treating women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer who have received prior endocrine therapy. Ribociclib in combination

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NICE Patisiran approval puts Alnylam back in hATTR running

NICE recommends use of Alnylam’s Patisiran, after issuing a preliminary ‘no’ back in December 2018. The treatment is for a progressive, life-threatening disease called hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis), which until recently, was an area of significant unmet need in England. The drug will now provide eligible patients suffering from the disease with a treatment

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NICE approves Amgen’s leukaemia treatment

NICE announces the recommendation of Amgen’s blinatumomab for treating acute lymphoblastic leukaemia (ALL). The indication is for patients in first complete remission with minimal residual disease (MRD) activity of at least 0.1%. This decision to recommend the drug as a cost-effective use of NHS resources was made after the submission of new evidence from the

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FDA approve Lilly’s cluster headache treatment

FDA has announced approval of Eli Lilly’s Emgality (galcanezumab-gnlm), the first treatment for episodic cluster headache that reduces the frequency of attacks. Decision was made based on a clinical trial that compared the drug to placebo in 106 patients, and found that during a three-week period, patients taking Emgality experienced 8.7 fewer weekly cluster headache

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Akcea obtains NICE approval for stage 1 or 2 polyneuropathy in adult patients with hATTR

Akcea Therapeutics’ Inotersen has received recommendation from NICE, meaning the therapy will now be made available to NHS patients in England and Wales for the treatment of Stage 1 or Stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR).  hATTR is a serious condition caused by “the abnormal formation of the TTR protein

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