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NICE shoots down Keytruda in head and neck cancer over data concerns

It has been revealed that NICE has chosen to reject MSD’s blockbuster immunotherapy Keytruda (pembrolizumab) for routine use on the NHS as a treatment for metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC), citing uncertainty over the data provided by the manufacturer.

Data submitted to the institute argued that Keytruda, either as a monotherapy or in combination with platinum chemotherapy and 5-FU, extended overall survival in those with PD-L1 positive HNSCC compared to Eli Lilly’s Erbitux (cetuximab) plus platinum chemotherapy and 5-FU.

MSD's Keytruda chalks up bladder cancer approval in the US

MSD’s blockbuster immunotherapy Keytruda (pembrolizumab) has added another US approval to its repertoire with the news that FDA has awarded marketing authorisation to the therapy for the treatment of a specific form of bladder cancer.

Specifically, the ruling was made in regard to patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours who are ineligible for or have elected not to undergo cystectomy.

Bittersweet Phase 3 Keytruda data hits one of two goals in extensive stage small cell lung cancer

MSD has lifted the curtain on new Phase 3 data on the efficacy of its blockbuster immunotherapy Keytruda, in combination with etoposide plus cisplatin or carboplatin chemotherapy, in the treatment of extensive stage small cell lung cancer (ES-SCLC) in the first-line setting, showing that the combo met one of its primary endpoints, but not both.

FDA advisory panel back Merck & Co.’s Keytruda treatment for bladder cancer

An FDA advisory committee voted 9 to 4 in favour of recommending Merk and Co’s Keytruda (pembrolizumab) for treatment in patients with high-risk, non-muscle-invasive bladder cancer (NMIBC).

The FDA is expected to reach a decision, based on a priority review, in January 2020.

Prostate Cancer ‘super responders’ could live for two more years on Keytruda

Men with advanced prostate cancer, who have exhausted all treatment options, could use the immunotherapy Keytruda (pembrolizumab) to live for another two years or more.

A major clinical trial showed that a small proportion of men were ‘super responders’ and were alive and well even after the trial had ended, despite having had a very poor prognosis before treatment.

Europe approves Keytruda for first-line head and neck squamous cell carcinoma, as a monotherapy or combo

MSD’s top-selling immunotherapy Keytruda (pembrolizumab) has secured another approval from the European Commission, this time in the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in patients whose tumours express PD-L1.

Phase 3 data supporting the application demonstrated that Keytruda significantly improved overall survival compared with standard treatment (cetuximab with carboplatin or cisplatin plus 5-FU), either as a monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy.

Keytruda overtakes Opdivo to lead sales in global immune checkpoint inhibitor market, report reveals

MSD’s Keytruda (pembrolizumab) overtook Bristol-Myers Squibb’s (BMS) blockbuster drug Opdivo (nivolumab) in total sales in the third quarter of 2019 to emerge as leader in the global immune checkpoint inhibitor market, according to a new report from GlobalData.

According to the findings, MSD’s drug saw a 62% growth in revenue compared to Q3 2018 to reach $3.1 million. Over the same period, Opdivo experienced sales growth of just 1%, generating $1.8 million

Scotland approves first-line NHS use of MSD's Keytruda combo for advanced non-small cell lung cancer

The Scottish Medicines Consortium (SMC) has announced its decision to accept MSD’s blockbuster immunotherapy Keytruda (pembrolizumab) in combination with pemetrexed and platinum chemotherapy on the NHS in Scotland for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) patients.

The decision affects patients whose tumours express PD-L1 with a <50% tumour proportion score (TPS), or in when it has not been possible to evaluate PD-L1 TPS, but excludes patients whose tumours have the specific gene mutations EGFR or ALK.

US, Canada and Australia simultaneously fast-track Keytruda/Lenvima combo for endometrial cancer

The FDA has acted under a new initiative in collaboration with the Australian Therapeutic Goods Administration (TGA) and Health Canada, conducting simultaneous review in all three countries to award accelerated approval to the combination of Keytruda (pembrolizumab)and Eisai's Lenvima (lenvatinib) for the treatment of advanced endometrial carcinoma.

Project Orbis, as the initiative is known, “provides a framework for concurrent submission and review of oncology drugs among its international partners”, potentially facilitating earlier access to medicines by overcoming delays in regu

MSD's Keytruda approved for first-line lung cancer use on NHS Scotland

MSD and lung cancer patients will be celebrating the news that the pharma giant’s immunotherapy Keytruda (pembrolizumab) has been accepted by the Scottish Medicines Consortium (SMC), in combination with carboplatin and paclitaxel chemotherapy, for the first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC).

The decision means that Keytruda becomes the first drug approved in Scotland in the first-line treatment of this indication; patients will be able to access the drug on the NHS, but only those whose tumours express programmed death ligand 1 (PD-L1) with a

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