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MSD's Keytruda chalks up FDA approval in liver cancer

MSD’s blockbuster immunotherapy Keytruda has secured another FDA approval, this time for the treatment of hepatocellular carcinoma (HCC) in patients who have already received current standard of care sorafenib.

The approval, awarded under the agency’s accelerated pathway, comes just days after Eisai’s Lenvima was recommended in England and Wales by NICE for the untreated, advanced, unresectable forms of the same condition.

MSD's Keytruda/chemo combo scores first-line FDA approval in NSC lung cancer

MSD’s blockbuster anti-PD-1 immunotherapy has secured another FDA approval, it has emerged, in combination with carboplatin and either paclitaxel or nab-paclitaxel chemotherapy, for the first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC).

The US regulator’s decision was based on Phase 3 data which demonstrated significant overall survival benefit of Keytruda regardless of the tumour PD-L1 expression status of a patient, with it found to reduce the risk of death by 36% compared to chemotherapy alone.

First-line Keytruda shows better overall survival in head & neck cancer

MSD’s Keytruda (pembrolizumab) made an impact at the European Society for Medical Oncology 2018 Congress as the company unveiled new Phase 3 data into its efficacy in the first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), revealing it met its primary endpoint.

In patients whose tumours expressed PD-L1 with a combined positive score (CPS) of at least 20, the findings demonstrated that, when used as a monotherapy, Keytruda improved overall survival (OS) rates by 39% compared to the EXTREME regimen of Merck KGaA’s Erbitux (cetuximab) plus ci

MSD's Keytruda with Pfizer's Inlyta beats Sutent in most common kidney cancer

MSD has unveiled new Phase 3 data on its blockbuster anti-PD-1 cancer therapy Keytruda (pembrolizumab) as part of a combination, this time with Pfizer’s tyrosine kinase inhibitor Inlyta (axitinib) as a first-line treatment for the most common kidney cancer, advanced or metastatic renal cell carcinoma (RCC), showing that the combo met both its primary endpoints.

The data revealed, according to an interim analysis by the independent Data Monitoring Committee (DMC), that the Keytruda/Inlyta  combo demonstrated statistically significant and clinically meaningful improvements in ov

MSD to launch Keytruda at half US list price in China

US pharma giant MSD will offer cutting edge cancer treatment Keytruda to Chinese patients at half the price at what it is sold for in the United States, according to the Beijing-based news organisation Caixin Global.

Keytruda, which was approved in China in July of this year, will cost 17,918 yuan (£1,981) for a 100mg/ 4ml dose when it is introduced to the world’s second largest pharmaceutical market later this year.

Keytruda scores ground-breaking European approval in lung cancer subgroup

Keytruda (pembrolizumab) has chalked up yet another approval for MSD, this time in Europe in combination with permextred and platinum-based chemotherapy in the first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) in adults with no EGFR or ALK positive mutations, making it the only immunotherapy licensed for use with chemo in the condition within Europe.

The European Commission authorised the drug combo based on data derived from a trial examining its use in patients with no, low and high expression of the biomarker PD-L1, which showed that Keytruda &nb

NICE recommends MSD's Keytruda for advanced PD-L1-positive lung cancer

UK drug watchdog NICE has chosen to issue final guidance recommending the use of MSD’s Keytruda (pembrolizumab) on the NHS for the treatment of previously untreated PD-L1-positive metastatic non-small-cell lung cancer (NSCLC) in adult patients.

The decision means that the drug is the first immunotherapy to prove its cost-effectiveness by sufficiently backing up its efficacy and to be recommended for baseline commissioning after following its exit from the Cancer Drugs Fund (CDF).

MSD’s Keytruda scores impressive first-line lung cancer data

MSD Keytruda has enjoyed the most success of the PD-1/L1 therapies in clinical trials recently and it’s rapidly cementing its position as the leader in the field with another set of stellar data, this time in metastatic squamous non-small cell lung cancer on a first-line basis.

Keytruda was used in conjunction with chemotherapy and managed to hit both its primary endpoints in overall survival and progression-free survival.

The May 2018 issue of Pharmafocus is now live!

Just in time for the first good weather of the year, the May 2018 edition of Pharmafocus is available to read online now!

Top Ten most popular articles on this week

It's the end of another week and there's really been one story that has dominated the headlines – Takeda’s potential takeover of Shire. It should come as no surprise that our most viewed story of the week relates to the purchase.

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