December 2011 Blog Posts (45)

Potential New Use of Denosumab Reviewed at FDA's Oncologic Drugs Advisory Committee Meeting

The U.S. Food and Drug Administration (FDA) has invited Amgen to participate in a meeting of the Oncologic Drugs Advisory Committee (ODAC) on Feb. 8, 2012 to discuss the supplemental Biologics License Application (sBLA) for denosumab (XGEVA®) to treat men with castration-resistant…

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Added by Peter Hofland, PhD on December 29, 2011 at 3:30pm — No Comments

Shared Risk Evaluation and Mitigation Strategy for TIRF Products Approved

The U.S. Food and Drug Administration approved a single shared Risk Evaluation and Mitigation Strategy (REMS) for the transmucosal immediate-release fentanyl (TIRF) products.



This new REMS is a single shared system for all TIRF products, including fentanyl sublingual tablets (Abstral®, ProStrakan/Orexo AB), an opioid analgesic…

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Added by Peter Hofland, PhD on December 29, 2011 at 11:30am — No Comments

New Targeted Therapy Extends Progression-Free Survival of Patients with Advanced Ovarian Cancer

Targeted drugs, which block or disrupt particular molecules involved in the growth of tumors, have been shown to be effective treatments against many types of cancer. A new phase III clinical trial conducted by the Gynecologic Oncology Group (GOG) showed that a targeted therapy called bevacizumab (Avastin®, Genentech/Roche) effectively delayed the progression of…

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Added by Peter Hofland, PhD on December 28, 2011 at 5:30pm — No Comments

Bevacizumab Receives EU Approval for the Treatment of Women with Newly Diagnosed, Advanced Ovarian Cancer; First Major Treatment in 15 Years

The European Commission has approved bevacizumab (Avastin®, Roche) in combination with standard chemotherapy (carboplatin and paclitaxel) as a first-line treatment following surgery for women with advanced ovarian…

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Added by Peter Hofland, PhD on December 23, 2011 at 10:00am — No Comments

Major Breakthroughs in Screening, Drug Treatment and Research Result in 2011 Being "The Turning Point" for Lung Cancer

Lung Cancer Alliance (LCA) President Laurie Fenton-Ambrose predicted that because of major breakthroughs this year in screening, treatment and research, 2011 will be defined as the turning point year for lung cancer.



"To paraphrase Churchill, this is not the end but it is certainly the beginning of the end," she said, "and 2011 will be remembered as the year that finally changed the course of lung cancer and led to thousands of lives being…

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Added by Peter Hofland, PhD on December 22, 2011 at 9:30am — No Comments

Offsetting the Hereditary Risk of Breast and Ovarian Cancer

Claudia Gilmore was 23 years old when, on January 11, 2011, she had a preventative double mastectomy with reconstruction. Her story is documented in a unique video project in which Gilmore shares her personal account of her experiences, feelings and decisions leading up to her surgery and what happened during her recovery and reconstruction. 



Gilmore did not have breast cancer. A genetic mutation made her more likely to develop breast and ovarian cancer cancerous cells…

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Added by Mariah Isabella McDermott on December 22, 2011 at 9:00am — No Comments

Normal Cells Can Fuel Tumor Growth After Losing Tumor Suppressor Gene

A new study published in the journal Nature Cell Biology discribes how researchers have discovered how normal cells in tumors can enhance and fuel tumor growth.



Led by researchers at the Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute…

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Added by Peter Hofland, PhD on December 21, 2011 at 6:30pm — No Comments

First Patient Treated in Phase IIa Clinical Trial of JX-594 as a Neoadjuvant Therapy in Colorectal Cancer

The first patient has been treated in a Phase IIa clinical trial of JX-594 as a neoadjuvant therapy in patients who are undergoing surgery to treat colorectal cancer that has spread to the liver.



Colorectal cancer is the second leading cause of cancer-related deaths in the United States and according to the World Health Organization, it accounts for approximately 639,000 deaths worldwide each year. Approximately one in 20 people in the United States will…

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Added by Peter Hofland, PhD on December 21, 2011 at 6:30am — No Comments

Study Does Not Show Higher Risk of Acute Leukemia in Close Relatives

Parents, siblings and children of patients with the most common form of acute leukemia do not run a higher risk of developing the disease as was once believed, according to a new study from the Swedish medical university Karolinska Institutet.



Every year, some 400 people in Sweden are diagnosed with acute myeloid leukemia (AML), the most common form of acute leukemia. Just like for other forms of the disease, the…

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Added by Peter Hofland, PhD on December 15, 2011 at 6:00pm — No Comments

Phase III Front-line Trial Planned with Brentuximab Vedotin in Advanced Stage Hodgkin Lymphoma Patients

Interim results from a phase I clinical trial of brentuximab vedotin(SGN-35, Adcetris™, Seattle Genetics/Millennium: The Takeda Oncology Company) in combination with chemotherapy for the treatment of newly diagnosed advanced stage Hodgkin lymphoma (HL) patients were…

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Added by Peter Hofland, PhD on December 13, 2011 at 5:00pm — No Comments

Deferasirox Shows Significant Reduction of Iron Overload in Patients with Non-Transfusion-Dependent Thalassemia

Results from thalassa-trial, the first pivotal placebo-controlled study examining the benefit of iron chelation with deferasirox (Exjade®, Novartis), an iron chelator, in patients with non-transfusion-dependent thalassemia (NTDT), show that deferasirox can significantly reduce iron overload. The researchers concluded that the drug is significantly better than placebo at…

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Added by Peter Hofland, PhD on December 13, 2011 at 9:00am — No Comments

Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma Experienced Disease Control in Phase II Romidepsin

Data from a sub-analysis of a Phase II, multicenter, international, open-label study of romidepsin (Istodax®, Celgene Corporation) in refractory or relapsed peripheral T-Cell lymphoma (PTCL) following prior systemic therapy, showed that 46% of patients experienced disease control for at least 90 days. Similar response rates demonstrated across most common subtypes of PTCL. The study results were presented by Professor Bertrand…

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Added by Peter Hofland, PhD on December 12, 2011 at 9:00pm — No Comments

Vorinostat in Combination with Bortezomib Results in Primary Endpoint of Improved PFS in Patients with Relapsed and/or Refractory Multiple Myeloma

A Phase III study of vorinostat (Zolinza®; Merck Sharp & Dohme/MSD)in combination with bortezomib (Velcade®; Millennium Pharmaceutical/Takeda Pharmaceutical)in patients with progressive multiple myeloma, demonstrated…

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Added by Peter Hofland, PhD on December 12, 2011 at 7:30pm — No Comments

JAK Inhibitor INC424 Significantly Reduces Disease Burden in Myelofibrosis

Data from two pivotal Phase III trials evaluating Janus kinase (JAK) inhibitor INC424 (ruxolitinib; Jakafi™ Novartis, Incyte) in myelofibrosis shows a clinical relevant and statistically significant improvement in symptoms compared to the best available therapy (BAT). The results of these…

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Added by Peter Hofland, PhD on December 12, 2011 at 6:30pm — No Comments

Patients with Acute Myeloid Leukemia Have High Response Rate with Vorinostat Added to Ongoing Treatment

Adding a drug that activates genes to frontline combination therapy for acute myeloid leukemia (AML) resulted in an 85% remission rate after initial treatment, researchers at The University of Texas MD Anderson Cancer Center reported at the 53rd Annual Meeting of the American Society of Hematology.



"Results of the Phase II clinical trial of 75…

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Added by Peter Hofland, PhD on December 12, 2011 at 6:00pm — No Comments

Chemotherapy and Radiation Do Not Increase Risk of Birth Defects in Children of Childhood Cancer Survivors

A large, retrospective study published in the Journal of Clinical Oncology, a tri-monthly peer-reviewed journal of the American Society of Clinical Oncology (ASCO), shows that children of childhood cancer survivors who received prior treatment involving radiation to testes or ovaries and/or chemotherapy with alkylating agents do not have an increased risk for birth…

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Added by Peter Hofland, PhD on December 12, 2011 at 6:00pm — No Comments

Updated Data for Brentuximab Vedotin Shows Durable Complete Remission and Manageable Toxicity

Updated data from a pivotal trial of single-agent brentuximab vedotin (adcetris™,Seattle Genetics) in patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL) presented at the 53rd Annual Meeting American Society of Hematology being held December 10 to 13, 2011 in San Diego, CA, shows durable complete remissions and treatment…

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Added by Peter Hofland, PhD on December 12, 2011 at 4:30pm — No Comments

Studies Show Sgnificantly Fewer Patients Progressed to Advanced Stages of Ph+ CML with Nilotinib Compared to Imatinib

Phase III clinical trial data presented at the 53rd Annual Meeting of the American Society of Hematology (ASH) in San Diego, CA, shows growing evidence that adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase who are treated with nilotinib (…

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Added by Peter Hofland, PhD on December 12, 2011 at 4:00pm — No Comments

Data on Brentuximab Vedotin Highlights Positive Findings and Clinically Meaningful Durations of Response

Data reported today demonstrating that prolonged treatment with Brentuximab Vedotin (SGN-35; Adcetris™, Seattle Genetics) beyond 16 cycles of therapy was associated with clinically meaningful durations of response with a manageable safety profile. In addition, data were presented showing that Brentuximab Vedotin is a viable option for reducing tumor burden prior to allogeneic stem cell transplant. The data were presented at the…

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Added by Peter Hofland, PhD on December 12, 2011 at 2:30pm — No Comments

Researchers Identify High-risk Subgroup of Older Patients with Primary Cytogenetically Normal AML and Mutated ASXL1

According to a new study by researchers at the Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, older people with acute myeloid leukemia and normal looking chromosomes in their cancer cells have a higher risk of recurrence if they have mutations in a gene called ASXL1 (additional sex combs like 1).



The findings were presented at the 53rd…

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Added by Peter Hofland, PhD on December 12, 2011 at 11:30am — No Comments

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