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
Roche’s early stage breast cancer treatment, Pertuzumab, hasbeen accepted by the Scottish Medicines Consortium (SMC) for use on the NHS in Scotland. The drug is used in combination with Trastuzumab and chemotherapy to treat a particular type of early stage breast cancer before surgery, and was accepted after consideration through SMC’s Patient and Clinician Engagement
FDA has started a six-month review of Roche’s Tecentriq, Avastin and chemotherapy in first-line non-small cell lung cancer, setting up a possible approval for the start of September this year. The triple therapy is an important tactic for Roche to catch up as it tries to build a market for new immuno-oncology drug Tecentriq and
The FDA have issued a complete response letter concerning Pfizer’s filing for a biosimilar version of Roche’s blockbuster cancer drug Herceptin. The FDA asked for more technical information, but Pfizer emphasised that it does not relate to safety or clinical data contained in the application. Although more information was not released, Pfizer said it is
NICE have issued final guidelines endorsing the use of Roche’s Esbriet to treat patients with idiopathic pulmonary fibrosis (IPF) in England and Wales, but only for those with moderate to severe forms of the disease. The cost regulators are sticking with its position that Esbriet should only be funded by the NHS if the person
NICE issues final green light and thus securing routine NHS funding for Roche’s Perjeta in patients with a certain type of breast cancer. The guidelines follow a confidential commercial agreement for Perjeta between NHS England and the Roche late last year, allowing for its move from the Cancer Drugs Fund to the NHS’ routine commissioning
NICE have recommended Roche’s Tecentriq for use within the Cancer Drugs Fund (CDF) to treat advanced urothelial cancer in specific circumstances. In final draft guidelines issued by the public body, Tecentriq is being backed for use in patients whose urothelial cancer has not yet been treated and who aren’t suitable for cisplatin-based chemotherapy. At first
The European Commission has approved Roche’s Alecensa as a second-line therapy for patients with ALK-positive non-small cell lung cancer (NSCLC). The decision was based on the results of two phase II studies, which showed that Alecensa shrank tumours in up to 52.2% of patients whose disease had progressed after treatment with Pfizer’s Xalkori, which is
The US Food and Drug Administration has approved Roche-group Genentech’s application to market Avastin for patients with a specific type of ovarian cancer. The drug has been cleared for use, either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine chemotherapy, followed by Avastin alone, to treat patients with platinum-sensitive recurrent
US regulators are conducting a priority review of Roche/Genentech’s experimental multiple sclerosis therapy Ocrevus, which some believe has the potential to transform treatment of the disease. Ocrevus is an investigational, humanised monoclonal antibody designed to selectively target CD20-positive B cells, a specific type of immune cell, that is believed to be a key contributor to
