The US Food and Drug Administration has recommended that the breast cancer indication be removed from Avastin (bevacizumab), which is used in combination with paclitaxel, because the treatment does not prolong overall survival. However, the European Medicines Agency said it will allow the indication to remain because there is still clinical benefit based on progression free survival.
ImmunoGen Inc of Waltham, Massachusetts has reported initial data from two early clinical trials of its antibody-drug conjugate for first-line treatment of breast cancer patients which showed meaningful response rates when the product, trastuzumab-DM1, was used as a single agent, or in combination with a monoclonal antibody. Data from a Phase 1b/2 trial, which was reported on 10 December, showed that 57.1% of patients with HER2 metastatic breast cancer responded to treatment with the drug, plus the antibody (pertuzumab). The study consisted of 21 patients who had not received prior systemic anticancer therapy for metastatic disease. In a separate Phase 2 study, 47.8% of 137 patients receiving trastuzumab-DM1 as a single agent responded to treatment. This compared with a response rate of 41.4% of patients treated with Herceptin and a taxane. The ImmunoGen antibody-drug conjugate consists of trastuzumab plus a cytotoxic agent and a linker.
Bavarian Nordic A/S has reached an agreement with the US Food and Drug Administration on the design of a Phase 3 trial for its candidate vaccine for prostate cancer, Prostvac. The Special Protocol Assessment was announced on 8 December.
Sanofi Pasteur is withdrawing its marketing authorisation application for Emerflu, a vaccine intended for prophylaxis of influenza in the event of a pandemic involving the influenza A virus subtype, H5N1, the European Medicines Agency said.
A US Food and Drug Administration advisory panel has voted not to recommend an expanded indication for the prostate cancer drug, dutasteride. The sponsor, GlaxoSmithKline, is seeking to have it approved for prostate cancer risk reduction.
The US Food and Drug Administration has issued a complete response letter for ezogabine, an investigational anti-epileptic drug, saying it cannot accept the application for marketing. GSK and Valeant Pharmaceuticals are the sponsors.
The European Medicines Agency has taken further steps to give the public access to documents relating to the regulatory decision-making process. The new policy will be implemented in a two-stages from 1 December 2010.
The consultation period has started for a guideline from the European Medicines Agency advising drug developers on the regulatory requirements for monoclonal antibody-containing medicines that claim to be similar to marketed biologics.
GlaxoSmithKline Plc has responded speedily to a new series of tax proposals from the UK government with a commitment to invest more than £500 million in manufacturing infrastructure in the country and to raise venture capital outlays.
Novartis International AG expects to make 30 regulatory submissions for new drugs before the end of 2012 as part of its plans to raise investment in original pharmaceutical research. Eight of these submissions will take place in 2010.