The European Commission has given conditional marketing authorization for crizotinib (Xalkori®, Pfizer)in the European Union (EU) for the treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). This ALK gene abnormality causes cancer development and growth. About 1% to 7% of those with NSCLC have the ALK gene abnormality. Patients with this form of lung cancer…
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Added by Peter Hofland, PhD on October 24, 2012 at 2:00pm —
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A multicenter study in Germany reports that it is feasible to routinely conduct high-quality molecular analysis of non-small cell lung cancers (NSCLC) in local community hospitals that are not affiliated with academic medical centers. The study results, presented at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO), indicate that molecular testing can be made available to more patients, and in many cases,…
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Added by Peter Hofland, PhD on June 5, 2012 at 7:30pm —
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Earlier today, the U.S. Food and Drug Administration (FDA) announced that the agency has approved axitinib (Inlyta®, Pfizer Inc) to treat patients with advanced or metastatic renal cell carcinoma (mRCC) who have not responded to another drug for this type of cancer. Axitinib helps keep the cancer from progressing.…
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Added by Peter Hofland, PhD on January 27, 2012 at 11:00am —
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Patients treated with sunitinib (Sutent®, Pfizer Oncology) and sorafenib (Nexavar®, Bayer Healthcare/Onxy Pharmaceuticals) responded to the flu vaccine, which suggests… Continue
Added by Peter Hofland, PhD on June 28, 2011 at 10:00pm —
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Results of preclinical studies on its investigational anaplastic lymphoma kinase (ALK) inhibitor, AP26113, shows that AP26113 has a novel profile as a dual inhibitor of ALK and epidermal growth factor receptor (EGFR), an additional validated target in non-small cell lung cancer (NSCLC). AP26113, developed by scientists at
Ariad Pharmaceuticals, exhibits unique preclinical activity and confers a best-in-class…
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Added by Peter Hofland, PhD on June 16, 2011 at 12:30pm —
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The European Medicines Agency (EMA) has accepted Pfizer’s filing for regulatory review of axitinib for patients with advanced renal cell carcinoma (RCC) after failure of prior systemic treatment. The new drug is under development by Pfizer. Axitinib,also known as AG013736, is an oral small…
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Added by Peter Hofland, PhD on June 1, 2011 at 7:30am —
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The U.S. Food and Drug Administration earlier today approved Sunitinib (Sutent®, Pfizer) for the treatment of advanced pancreatic neuroendocrine tumors located in the pancreas that cannot be removed by surgery.
Neuroendocrine tumors found in the pancreas are generally slower growing and less aggressive than the more common form of pancreatic cancer. It is estimated that there are fewer than 1,000 new cases in the United States each year, or lesss than 5% of…
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Added by Peter Hofland, PhD on May 20, 2011 at 3:30pm —
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Pharmaceutical giant Pfizer Inc. announced this week that it has initiated the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for crizotinib (PF-02341066), an oral first-in-class anaplastic lymphoma kinase (ALK) inhibitor in development for the treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors are ALK-positive. Pfizer expects to complete the submission in the first half of 2011.…
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Added by Peter Hofland, PhD on January 12, 2011 at 4:30pm —
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Pfizer and Seattle Genetics, a clinical-stage biotechnology company focused on the development and commercialization of monoclonal antibody-based therapies for the treatment of cancer , have entered into a collaboration in which Pfizer will pay an upfront fee of $8 million for rights to utilize Seattle Genetics' antibody-drug conjugate (ADC) technology with antibodies to a single oncology target.…
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Added by Peter Hofland, PhD on January 6, 2011 at 11:30am —
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The European Medicines Agency earlier today approved sunitinib malate (Sutent®, Pfizer) for the treatment of unresectable or metastatic, well-differentiated pancreatic… Continue
Added by Peter Hofland, PhD on December 2, 2010 at 3:30am —
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Earlier today Pfizer announced that the Phase III AXIS 1032 trial (A4061032), studying axitinib, also known as AG013736 [1], in previously treated patients with metastatic renal cell carcinoma (mRCC), has met its primary endpoint, demonstrating that axitinib significantly extended progression-free survival (PFS) when compared to sorafenib (… Continue
Added by Peter Hofland, PhD on November 19, 2010 at 5:00am —
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A new oral drug caused dramatic shrinkage of a patient's rare, aggressive form of soft-tissue cancer that was driven by an abnormally activated protein, physician-scientists from Dana-Farber Cancer Institute report in the Oct. 28 issue of the New England Journal of Medicine (NEJM).A second patient who had a similar tumor that was not fueled by the mutant protein, called ALK (named for the first…
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Added by Peter Hofland, PhD on October 27, 2010 at 11:30am —
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The United Kingdom's health watchdog, the National Institute for Health and Clinical Excellence (NICE) earlier today published three separate pieces of guidance for the NHS on the use of the cancer drugs ofatumumab (Arzerra®, GlaxoSmithKline), temsirolimus (… Continue
Added by Peter Hofland, PhD on October 27, 2010 at 10:00am —
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A new-generation lung cancer drug has shown an impressive ability to prevent disease progression when administered as a first-line treatment in patients with advanced disease, investigators reported at the 35th Congress of the European Society for Medical Oncology (ESMO).Preliminary results from an ongoing Phase-II trial of the drug PF299804 (PF-299) showed that close to 85% of patients whose cancers harbor mutated forms of the EGFR gene have remained…
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Added by Peter Hofland, PhD on October 11, 2010 at 5:30am —
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Earlier today, Pfizer Inc. announced that it has discontinued the SUN 1120 Phase III trial evaluating sunitinib malate (Sutent®), an oral multi-kinase inhibitor, in combination with prednisone for men with advanced castration-resistant prostate cancer (CRPC) that had progressed despite treatment with a docetaxel-based chemotherapy regimen.During a scheduled interim analysis, an independent Data Monitoring Committee (DMC) found that the combination of…
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Added by Peter Hofland, PhD on September 27, 2010 at 2:30pm —
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Earlier today, Pfizer Inc. announced that it voluntary withdraws gemtuzumab ozogamicin (Mylotarg) from the U.S.market. The drug is being used for patients with acute myeloid leukemia (AML), a bone marrow cancer. The company took the action at the request of the U.S. Food and Drug Administration after results from a recent clinical trial raised new concerns about the product’s safety and the drug failed to demonstrate clinical benefit to patients enrolled in… Continue
Added by Peter Hofland, PhD on June 21, 2010 at 2:00pm —
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