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FDA expands Keytruda label to include stage 3 and 4 non-small cell lung cancer

MSD has revealed that its anti-PD-1 therapy Keytruda (pembrolizumab) has received expanded indication from the FDA to include the first-line treatment of stage 3 or metastatic non-small cell lung cancer (NSCLC).

Specifically, the indication relates to stage 3 patients who are not candidates for surgical resection or definitive chemoradiation, and those whose tumours express PD-L1 as determined by an FDA-approved test, with no EGFR or ALK genomic tumour aberrations.

Top Ten most popular articles on Pharmafile.com this week!

This week was an excellent week for recommendations and approvals after Eisai, MSD, Pfizer, BMS and ViiV scored wins. Meanwhile Britain’s cost effectiveness body NICE turned down Astellas’ Xtandi in prostate cancer.

Nevertheless our top story looked at Gilead’s announcement they would be laying off one fifth of their workforce. The news came as shares in Indivior plummeted by as much as 70% amid fraud allegations.

Europe approves Lynparza in HER2-, gBRCAm advanced breast cancer

Lynparza (olparib), the poly ADP ribose polymerase (PARP) inhibitor developed by AstraZeneca and MSD, has been awarded marketing approval by the European Commission, it has emerged, as a monotherapy for the treatment of human epidermal growth factor receptor 2 (HER2)-negative locally-advanced or metastatic breast cancer with germline BRCA1/2-mutations (gBRCAm).

Phase 3 data submitted in support of the application demonstrated that Lynparza improved median progression-free survival by 2.8 months and doubled objective response rates to 52% from 23% compared to physician’s choice of c

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.

Lynparza extends progression-free survival in gBRCAm metastatic pancreatic cancer

AstraZeneca and MSD have lifted the curtain on new Phase 3 data for Lynparza (olaparib), confirming that the drug generated a “statistically-significant and clinically-meaningful improvement” in progression-free survival (PFS) compared to placebo as a first-line maintenance monotherapy in germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer in patients whose disease has not progressed on platinum-based chemotherapy.

According to the pair, the data make Lynparza the first PARP inhibitor to demonstrate benefit in this indication at Phase 3.

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.

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