The US Food and Drug Administration has approved a new treatment option for Tarceva (erlotinib) for patients with locally advanced or metastatic non-small cell lung cancer. This follows a positive opinion for the same indication from the EMA.
BioAlliance Pharma SA said that it has won approval from the US Food and Drug Administration to market its anti-fungal therapy, Loramyc, to treat patients whose immune systems have been compromised following chemotherapy or radiotherapy.
The US Food and Drug Administration has said it can’t approve a new lipid-lowering drug from AstraZeneca Plc and Abbott Laboratories without further data. The two companies announced receiving the complete response letter on 30 March 2010.
The Roche group said that its cancer drug, Xeloda (capecitabine) has been approved in Europe in combination with the chemotherapy drug, oxaliplatin, for the adjuvant treatment of patients with early colon cancer. The combination is called Xelox.
The European Medicines Agency is recommending that the cancer drug, Tarceva (erlotinib), be approved for maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer. This represents a new treatment option.
Pfizer Inc has announced that two Phase 3 studies of Sutent (sunitinib malate) in advanced breast cancer did not meet their primary endpoints. The drug is currently approved for gastrointestinal stromal tumour and advanced renal cell carcinoma. The company announced the trial results on 11 March 2010.
A Phase 3 trial of Avastin (bevacizumab) in combination with docetaxel and prednisone in men with late-stage prostate cancer has failed to meet its primary endpoint of extending overall survival, the Roche Group announced.
Actelion Ltd said that it has received a complete response letter from the US Food and Drug Administration for its treatment for Niemann-Pick disease, Zavesca (miglustat). This means the agency cannot approve the application in its present form.
Ark Therapeutics Group Plc has dropped its appeal against a negative opinion from the European Medicines Agency for its gene therapy for brain cancer, Cerepro. It also announced that it is in talks about a possible takeover of the company. Ark disclosed the developments on 9 March 2010.
Genmab A/S said that its antibody for head and neck cancer, zalutumumab, has failed to show overall survival in a Phase 3 study in which the drug was being tested in combination with best supportive care versus best standard care alone.