Swiss drug regulators have become the first to approve Novartis' Tasigna (nilotinib) for the treatment of patients with Ph+ chronic myeloid leukemia who are resistant or intolerant to imatinib (Gleevec), based on phase II results (see page 26). The drug is under review by the US Food and Drug Administration (FDA).
The Swiss have also authorized Northwest Biotherapeutics' DCVax-Brain for the treatment of brain cancer. The company will be permitted to manufacture DCVax-Brain in the United States and make it available for patients at select centers in Switzerland. DCVax products are made by combining a patient's own dendritic cells with cancer biomarkers derived from or displayed by the tumor.
The European Union has recommended approval of Avastin (bevacizumab) as first-line therapy of advanced non-small-cell lung cancer, in combination with chemotherapy. The US FDA gave approval for this indication last October.
After Eli Lilly challenged an earlier denial, the UK's National Institute for Health and Clinical Excellence (NICE) has recommended that Alimta (pemetrexed) be made available for treatment of advanced inoperable malignant pleural mesothelioma. NICE originally did not recommend Alimta for this indication due to cost concerns.