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China approves Keytruda for non-small cell lung cancer

US firm MSD has won approval for Keytruda in China. The cancer immunotherapy has thus become the first PD-1 inhibitor approved for multiple tumour types in China.

The approval makes Keytruda (pembrolizumab) a first line treatment option alongside chemotherapy for patients in China with metastatic non-squamous non-small cell lung cancer (NSCLC). The indication brought in more than $7 billion in sales in 2018.

MSD's Keytruda/chemo combo nabs EU approval in first-line metastatic squamous lung cancer

MSD’s anti-PD-L1 therapy Keytruda (pembrolizumab) has been awarded marketing authorisation in Europe for the first-line treatment of adult patients with metastatic squamous non-small cell lung cancer (NSCLC) when used in combination with carboplatin and either paclitaxel or nab-paclitaxel, it has emerged.

Phase 3 data submitted in support of the application illustrated that the combo “significantly improved overall survival (OS)”, reducing risk of death by 36% compared to chemotherapy alone regardless of a patient’s PD-L1 tumour expression status.

Top Ten most popular articles on Pharmafile.com this week

Happy Friday! With the weekend within reach, check out our run-down of the top ten most popular articles on Pharmafile.com this week, including Keytruda's liver cancer failure, a "game-changing osteoasrthritis treatment, AstraZeneca's retirement of the MedImmune brand, and the promise of the first new asthma pill in two decades.

10. Poland and Slovenia included in US-EU mutual recognition agreement

Keytruda falls short at Phase 3 in advanced liver cancer

MSD has revealed new Phase 3 data which indicates that its blockbuster immunotherapy Keytruda (pembrolizumab), in combination with best supportive care, failed to meet its primary endpoints of overall survival or progression-free survival in the treatment of patients with advanced hepatocellular carcinoma (HCC) who were previously treated with systemic therapy.

The company noted that both rates for the Keytruda arm of the study were superior to those in the placebo arm, but these did not reach statistical significance.

MSD's Keytruda combo therapy significantly improves survival in advanced renal cell carcinoma

Merck & Co’s Keytruda (pembrolizumab) in combination with Pfizer’s Inlyta (axitinib) significantly extended the lives of those with advanced renal cell carcinoma (RCC) and delayed disease progression and death according to the results of a Phase 3 clinical trial.

The combo outperformed Pfizer’s Sutent – the current standard of care first line treatment for advanced RCC patients.

Keytruda + Inlyta combo beats Pfizer's chemotherapy Sutent in renal cell carcinoma

New data has been revealed on the efficacy of MSD’s Keytruda (pembrolizumab) in combination with Pfizer’s Inlyta (axitinib), showing it successfully reduced the risk of death by almost half in advanced renal carcinoma (RCC) patients compared to Pfizer’s chemotherapy drug Sutent.

Specifically, the combo reduced the risk of death in RCC by 47%, while risk of disease progression or death was reduced by almost 40%. In addition, overall response rate was 20% higher than that shown by Sutent.  

MSD's Keytruda boosts overall survival by 31% in advanced oesophageal cancer

MSD has unveiled new Phase 3 data for its blockbuster anti-PD-1 immunotherapy Keytruda (pembrolizumab), showing that the drug succeeded in hitting its primary endpoint of improving overall survival (OS) as a monotherapy in the second-line treatment of of advanced or metastatic esophageal or esophagogastric junction carcinoma.

The company said that the results represented the first time that an anti-PD-1 therapy has shown a survival benefit in this patient population.

Cancer Drugs Fund to offer MSD's Keytruda for lung cancer

MSD’s Keytruda (pembrolizumab) will now be made available via the Cancer Drugs Fund for patients in England, as NICE announces it has agreed to recommend the drug in treatment-naive non-small-cell lung cancer, whose tumours have no epidermal growth factor receptor (EGFR)- or anaplastic lymphoma kinase (ALK)-positive mutations.

The submission of evidence to support the drug’s benefits drove the decision, showing that Keytruda improvised progression-free survival by around four months compared to standard of care pemetrexed with platinum chemotherapy, allowing NICE to determine that

MSD's Keytruda to treat melanoma in England on the Cancer Drugs Fund

MSD’s blockbuster immunotherapy Keytruda (pembrolizumab) will now be made available to patients in England via the Cancer Drugs Fund, it has emerged. The new ruling covers the therapy for the treatment of melanoma following surgery in those whose cancer has spread to the lymph nodes.

According to the clinical data which shaped the decision, Keytruda can extend progression-free survival with almost one in four patients remaining cancer-free after 18 months of treatment, compared to around half of patients with placebo.

MSD's Keytruda improvess overall survival in Phase 3 oesophageal cancer

MSD has announced new Phase 3 data on its anti-PD-1 therapy Keytruda (pembrolizumab) as a second-line treatment for advanced or metastatic esophageal or esophagogastric junction carcinoma, demonstrating that the drug hit its primary endpoint in improving overall survival (OS) of patients with PD-L1+ tumours.

In 600 participants with advanced or metastatic adenocarcinoma or squamous cell carcinoma of the oesophagus, or Siewert type I adenocarcinoma of the oesophagogastric junction for which first-line therapy has proven ineffective, and with a Combined Positive Score ≥10, Keytruda p

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