The Roche group has announced European approval of its cancer drug, Tarceva (erlotinib), as a first-line therapy for patients with non-small cell lung cancer whose tumours express mutations of the epidermal growth factor receptor (EGFR).
The US Food and Drug Administration has issued a ‘complete response letter’ to Novartis for its proposed treatment for gouty arthritis, canakinumab, requesting additional data on the drug’s benefit-risk profile in difficult-to-treat patients.
The US Food and Drug Administration has approved a new personalised medicine, Xalkori (crizotinib) together with a diagnostic, for the treatment of patients with late-stage non-small cell lung cancer who have abnormalities of the ALK gene.
The US Food and Drug Administration has approved Shire Plc’s new drug for acute attacks of hereditary angioedema, Firazyr (icatibant), the third treatment to be approved by the US regulator for this disease.
The US Food and Drug Administration has approved an antibody-drug conjugate for the treatment of Hodgkin lymphoma, the first approved treatment for this disease since 1977. The same drug was also approved for anaplastic large-cell lymphoma.
The US Food and Drug Administration has approved a new personalised medicine, Zelboraf (vemurafenib), for metastatic melanoma that targets mutated forms of the BRAF protein, and a companion diagnostic. The developer is the Roche group.
Pharming Group NV has reached an agreement with the US Food and Drug Administration on the design of a Phase 3 trial for its prospective treatment for hereditary angioedema (HAE), Rhucin. Under the agreement, Pharming will amend the protocol of the study and introduce a new method for assessing its primary endpoint.
The European Medicines Agency has agreed to a recall of Vimpat (lacosamide), a medicine used to treat epilepsy because of a quality defect in some batches. No adverse reactions have been reported. The developer, UCB SA, proposed the recall.
The European Medicines Agency is recommending approval of a new medicine for chronic hepatitis C in adults, Incivo (telaprevir). The developer is Janssen Pharmaceutical and the drug was approved by the FDA in May.
The European Medicines Agency is recommending that pioglitazone-containing medicines for diabetes, including Actos, carry a warning of a small increased risk of bladder cancer. However it said the benefit-risk of the drugs remains positive.