Positive Results for Pfizer’s Lung Cancer Therapy, Xalkori

click Xalkori” src=”http://i61.tinypic.com/kng1x.jpg” width=”204″ height=”126″ />Pfizer have announced positive late-stage clinical data from a phase III trial of Xalkori, in comparison to chemotherapy. Pfizer revealed that the clinical study met the primary objective of significantly prolonging progression-free survival in previously-untreated patients with anaplastic lymphoma kinase (ALK)-positive advanced non-squamous non-small cell lung cancer (NSCLC), when compared

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NICE Draft Guidance Rejects Bayer’s Xofigo

The National Institute for Health and Care Excellence (NICE) today published draft regulatory guidance rejecting Bayer’s Xofigo for patients with prostate cancer. Xofigo has been submitted to the regulatory body to treat patients with hormone relapsed prostate cancer, symptomatic bone metastases and no known visceral metastases. Clinical trials have demonstrated that Xofigo can significantly improve

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GlaxoSmithKline’s Tafinlar Receives EU Approval

GlaxoSmithKline’s (GSK) Tafinlar has been given the green light by the European Commission to be used as an oral treatment for unresectable or metastatic melanoma in adults with a BRAF V600 mutation. Tafinlar (dabrafenib) is an orally bioavailable inhibitor of BRAF,  part of the pathway that regulates the normal growth and death of cells.  Mutations

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Boehringer Submits Afatinib to EMA

Boehringer Ingelheim announced earlier today that they have submitted their first oncology compound, afatinib, to European regulators. The German firm filed a marketing authorisation application to the European Medicines Agency (EMA) for the approval of afatinib as a treatment for patients with EGFR (ErbB1) mutation positive non-small cell lung cancer (NSCLC).  Boehringer confirmed that afatinib

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Teva’s Version of Neupogen Approved by FDA

The US FDA (Food and Drug Administration) have approved Teva Pharmaceutical Industries’ form of Amgen’s severe neutropenia therapy, Neupogen. The FDA have approved tbo-filgrastim, which Teva noted is the first new granulocyte colony-stimulating factor (G-CSF) to be backed by the US agency in over 10 years.  The drug is a copy of Neupogen (filgrastim), which

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NICE Requests Further Information on Zelboraf

The National Institute for Health and Clinical Excellence (NICE) has issued a second draft guidance to Roche asking them to provide additional information on the use of their skin cancer drug, Zelboraf (vemurafenib). The request concerns Zelboraf’s use in the treatment of unresectable locally-advanced or metatastic BRAF V600 mutation-positive melanoma, for which NICE announced, in

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Novartis’ Afinitor Approved for Breast Cancer by FDA

Novartis announced on Friday that they have received approval from US regulators for Afinitor as a treatment for advanced breast cancer. The US Food and Drug Administration (FDA) have given the thumbs up to Afinitor (everolimus) for use with Pfizer’s Aromasin (exemestane) to treat certain postmenopausal women with advanced hormone-receptor positive, HER2-negative breast cancer.  The

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