The European Commission has approved AstraZeneca (AZ) and Merck/MSD’s PARP-inhibitor Lynparza for the treatment of patients with BRCA-mutated metastatic pancreatic cancer. The approval was based on results from the phase 3 POLO trial of Lynparza in advanced pancreatic cancer patients whose tumours carry BRCA mutations. About 5-7% of metastatic pancreatic cancers are caused by mutations in one
FDA has launched Project Patient Voice, an initiative of the FDA’s Oncology Center of Excellence (OCE). Through a new website, Project Patient Voice creates a consistent source of publicly available information describing patient-reported symptoms from cancer trials for marketed treatments. While this patient-reported data has historically been analysed by the FDA during the drug approval
EMA has decided on a positive opinion for a new combo of MSD’s cancer blockbuster, Keytruda (pembrolizumab) and Inlyta (axitinib). The organisation’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of the anti-PD-1 therapy and Inlyta combo, a tyrosine kinase inhibitor, for the first-line treatment of patients with advanced
Roche’s Atezolizumab has won US clearance for use in combination with carboplatin and etoposide (chemotherapy) as first-line treatment for extensive-stage small cell lung cancer (ES-SCLC) in the US, offering patients the first new treatment in more than 20 years. The approval follows data from the Phase III IMpower133 study, which showed that Atezolizumab in combination
The MHRA has given formal approval for Redx to re-commence a Phase I/IIa trial of experimental cancer therapy RXC004. RXC004 is an oral porcupine inhibitor targeting the Wnt signalling pathway, with the Phase I/IIa trial on track to resume in the first half of 2019. Lisa Anson, chief executive of the firm, commented: “I am
The European Commission has approved Bristol-Myers Squibb’s Opdivo in combination with low-dose Yervoy for first-line treatment for patients with intermediate and poor risk advanced renal cell carcinoma (RCC). BMS has stated that the approval marks the first of an immuno-oncology combination therapy for patients with this type of cancer in the European Union. Clearance is
NHS has three months to ensure that Novartis’ combination therapy dabrafenib/trametinib is routinely available to eligible skin cancer patients, after cost regulators published guidance backing funds for the treatment. NICE recommended the combination for use in patients with stage III BRAF V600 mutation-positive melanoma that has spread to lymph vessels, or lymph glands close to
Clovis Oncology’s Rucaparib has been designated as a Breakthrough Therapy by the FDA in prostate cancer, paving the way for a faster review if clinical trials achieves favourable results. The FDA has said that phase 2 data suggest the drug could represent a new therapy option for men whose cancer has progressed despite chemotherapy, and
AstraZeneca’s durvalumab has been approved in Europe for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC). The decision enables doctors to prescribe the drug for adults with stage III NSCLC whose tumours express PD-L1 on ≥1% of tumour cells and whose disease has not progressed following platinum-based chemotherapy and radiation therapy (CRT). The
FDA are conducting a priority review of MSD’s Keytruda, a treatment for adult and paediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This application is based on data from the Phase II KEYNOTE-017 trial, which showed an objective response rate of 56% at 14.9 months in patients taking the immunotherapy, including
