It is looking unlikely that Janssen’s Zytiga plus androgen deprivation therapy and prednisone/prednisolone will become routinely available on the NHS as a first-line treatment for patients with high-risk hormone-sensitive metastatic prostate cancer.
News
US nod for Alimta/Keytruda lung cancer combo
US regulators have approved a combination of Eli Lilly’s Alimta and MSD’s Keytruda as first-line treatment for patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), irrespective of PD-L1 expression status.
Priority review for Roche’s Hemlibra
Roche’s Hemlibra will get a speedy review in the US for adults and children with haemophilia A without factor VIII inhibitors.
UK to develop world’s first ‘hands-free’ drug discovery lab
In a world first, the UK government has announced a new project to develop a fully-automated drug discovery facility to accelerate the production of new medicines and “transform” the pharma industry.
UK sees 20 percent hike in cases of syphilis
Public Health England has reported a 20 percent increase in cases of syphilis in just one year, marking the highest number since 1949.
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AZ, MSD’s Lynparza/abiraterone combo hits prostate cancer goals
AstraZeneca and MSD have presented data at ASCO showing improvement in radiologic progression-free survival in prostate cancer patients taking a combination of Lynparza and abiraterone.
NICE rules against first-line use of Ipsen’s Cabometyx
The National Institute for Health and Care Excellence has issued a preliminary decision rejecting first-line use of Ipsen/Exelixis’ Cabometyx in renal cancer on the NHS.
EU filing for Clovis’ Rubraca in ovarian cancer maintenance setting
Clovis Oncology is seeking to expand use of its PARP inhibitor Rubraca in Europe to include maintenance treatment of certain adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
BMS’ Opdivo cuts risk of melanoma recurrence
Bristol-Myers Squibb’s Opdivo, which is being investigated as adjuvant treatment after surgery for stage IIIb/c or IV melanoma patients at high risk of recurrence, may significantly cut the risk of patients’ cancer returning.
US OKs first biosimilar of Amgen’s Neulasta
Mylan and Biocon’s Fulphila has become the first biosimilar of Amgen’s Neulasta to be approved by the US Food and Drug Administration.
Trial first to show immunotherapy benefit in prostate cancer
An international trial led by The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust has shown that immunotherapy can benefit men with prostate cancer.
MSD’s Keytruda takes lead in squamous NSCLC trials
MSD’s Keytruda has shown a greater benefit than Roche’s Tecentriq in separate (and incomparable) clinical trials exploring the effectiveness of the anti-PD-1 therapies in treatment-naiive patients with squamous non-small cell lung cancer.
US approves Lilly/Incyte’s Olumiant
As expected, US regulators have approved the lower dose of Eli Lilly/Incyte’s once-daily JAK inhibitor Olumiant as treatment for rheumatoid arthritis (RA).
Novartis’ Aimovig leads CHMP recommendations
The European Medicines Agency’s Committee for Medicinal Products for Human Use has endorsed nine medicines for approval at its May meeting, including Novartis’ Aimovig, the first human monoclonal antibody for migraine prevention.
