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Top Ten most popular articles on Pharmafile.com this week

On the day that UK Prime Minister Theresa May announces her resignation, we look back on the week's biggest stories in the pharmaceutical industry.

MSD buys Peloton Therapeutics in deal worth $2.1 billion

MSD has agreed to acquire all outstanding shares in Peloton Therapeutics in a deal worth up to $2.1 billion.

US firm MSD will pay Texas-based biotech Peloton Therapeutics $1 billion upfront and a further $1.15 billion based on the achievement of regulatory and sales milestones.

The acquisition comes as MSD seeks to boost its oncology pipeline with the addition of Peloton’s lead candidate cancer drug PT2977.

Keytruda fails to improve overall survival in advanced triple-negative breast cancer

MSD has made it known that its cancer immunotherapy Keytruda (pembrolizumab) failed to meet its primary endpoint in a Phase 3 study evaluating its efficacy as a monotherapy for the second- or third-line treatment of metastatic triple-negative breast cancer (TNBC).

The company revealed that the blockbuster anti-PD-1 drug failed to show superiority in improving overall survival compared to chemotherapy (capecitabine, eribulin, gemcitabine or vinorelbine). Because this primary endpoint was never met, all other endpoints were not formally tested.

MSD's Keytruda recommended on NHS in Scotland for Stage 3 melanoma

MSD has revealed that Keytruda (pembrolizumab) will be made available to NHS Scotland patients after the Scottish Medicines Consortium (SMC) decided to recommend the drug’s use as a monotherapy in the treatment of Stage 3 melanoma with lymph node involvement in adult patients who have undergone complete resection.

Thanks to the decision, access to the drug in this indication is now harmonised across the Great British mainland, following a recommendation from NICE in December 2018 to make the immunotherapy available on the NHS in England and Wales.

AZ and MSD's Lynparza secures CHMP nod in first-line BRCA-mutated ovarian cancer

AstraZeneca and MSD’s Lynparza (olaparib) has received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP), it has emerged, as a first-line maintenance treatment of BRCA-mutated advanced ovarian cancer.

Specifically, the recommendation covers the use of the drug as a maintenance treatment for adult patients advanced BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.

FDA approves Beximco's generic version of MSD's allergy drug Periactin

Bangladesh-based Beximco Pharma is celebrating following the decision from the FDA to approve its generic version of MSD’s antihistamine therapy Periactin (Cyproheptadine).

The 4mg generic tablet formulation is approved in the same indications as its reference product, including the treatment of allergy symptoms such as hives, sneezing, and itchy or watery eyes or nose.

Beximco said that the total market in the US for the mediciation was around $16 million in 2018.

Keytruda/Inlyta combo scores FDA approval in advanced kidney cancer

MSD’s anti-PD-1 therapy Keytruda (pembrolizumab) has secured another approval from the FDA, this time as a first-line treatment in combination with Pfizer’s Inlyta (axitinib) in advanced renal cell carcinoma.

The FDA made the decision based on Phase 3 data which showed that the combo significantly improved overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) compared to Pfizer’s Sutent (sunitinib).

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

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