August 2010 Blog Posts (7)

New Therapeutic Target in Pediatric Cancer: RNAi Screening Used For The First Ttime To Study Ewing’s Sarcoma

Ewing’s sarcomas are rare, but aggressive cancer lesions that occur most frequently in the bones of teenagers. They represent nearly 3% of all childhood cancers. Patients are treated with a combination of surgery, radiation and chemotherapy. This cancer can reoccur after surgical removal, and often spreads to the lungs, other bones and bone marrow. Once it spreads, or metastasizes, only 1 in 5 patients survive more than 5 years.

These lesions harbor unique… Continue

Added by Peter Hofland, PhD on August 31, 2010 at 6:00am — No Comments

FDA Rejects Accelerated Approval For T-DM1, Global Regulatory Submission Expected In Mid 2012

Earlier today the U.S. Food and Drug Administration (FDA) issued a Refuse to File letter for accelerated approval for the Roche's trastuzumab-DM1 (T-DM1) Biologics License Application (BLA). However, as planned, Roche will continue with its ongoing Phase III EMILIA registration study. Furthermore, Roche will continue to work with the FDA and expects a global regulatory submission of T-DM1 mid 2012.

T-DM1 is an antibody-drug conjugate (ADC), also known as an armed antibody,…


Added by Peter Hofland, PhD on August 27, 2010 at 9:30am — No Comments

FDA Grants New Recombinant Anti-CD20 Monoclonal Antibody Orphan Drug Status for CLL

The recombinant anti-CD20 monoclonal antibody (LFB-R603) produced by LFB Biotechnologies, a leading European biopharmaceutical company, received orphan drug status for the treatment of Chronic Lymphocytic Leukemia (CLL). This approval from the FDA Office of Orphan Products Development was granted on August 6th, 2010.

Chronic lymphocytic leukemia is the most common form of leukemia in the United… Continue

Added by Peter Hofland, PhD on August 26, 2010 at 6:30am — No Comments

Japan Approves Lenalidomide for Treatment of Deletion 5q Myelodysplastic Syndromes

Lenalidomide (Revlimid®, Celgene) has been granted full marketing authorization by Japan's Ministry of Health, Labour and Welfare (MHLW) for the treatment of patients with myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenic abnormality. Lenalidomide was also approved in June 2010 in combination with dexamethasone, for the treatment of patients with relapsed or refractory multiple myeloma who… Continue

Added by Peter Hofland, PhD on August 20, 2010 at 6:30am — No Comments

Technique to Preserve Fertility in Young Women May Be Unsafe for Patients With Leukemia

Although the use of ovarian tissue cryopreservation and transplantation has lead to 13 live births in women with lymphoma or solid tumors, this method of fertility preservation may be unsafe for patients with leukemia, according to a recent study published online in Blood , the journal of the American Society of Hematology.

The method involves… Continue

Added by Peter Hofland, PhD on August 13, 2010 at 11:30am — No Comments

FDA Approves New Docetaxel Injection Formulation

The U.S. Food and Drug Administration (FDA) has approved a new one-vial formulation of the chemotherapeutic agent docetaxel (Taxotere®, Sanofi-aventis). The 1-vial Taxotere is anticipated to become available to cancer treatment clinics and hospitals nationwide in the fall in both 80 mg and 20 mg dosages.

Introduced more than 14 years ago, docetaxel is approved by the FDA for use in treating patients at specific stages of 5 types of cancer: metastatic and… Continue

Added by Peter Hofland, PhD on August 5, 2010 at 9:30am — No Comments

American Society For Radiation Oncology Publishes Whole Breast Irradiation Guidelines

The American Society for Radiation Oncology (ASTRO), with more than 10,000 members the largest radiation oncology society in the world, has released evidence-based guidelines to define appropriate fractionation of whole breast irradiation (WBI), finding that hypofractionated (HF) WBI is effective for many patients with early-stage breast cancer. These guidelines are published in the International Journal of Radiation Oncology,… Continue

Added by Peter Hofland, PhD on August 4, 2010 at 10:00am — No Comments

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