AMSTERDAM, October 19, 2015 /PRNewswire/ --
myTomorrows (Amsterdam, the Netherlands) is pleased to announce that it has signed an agreement with Spectrum Pharmaceuticals, Inc. (Henderson, Nevada, USA) to manage the Early Access Program for pralatrexate in Europe.
myTomorrows is an expanded access provider that gives physicians and patients that are excluded from clinical trials access to drugs in development.
Spectrum Pharmaceuticals is a leading biotechnology company focused on acquiring, developing, and commercializing drug products, with a primary focus in oncology and hematology.
The pralatrexate injection, a folate analogue metabolic inhibitor, was granted accelerated approval in September 2009 by the U.S. Food and Drug Administration (FDA) for use as a single agent for the treatment of patients with relapsed or refractory PTCL. This approval is based on overall response rate. The study design of the pivotal trial allowed for measurement of overall response, but not progression free survival and overall survival. Pralatrexate is now available in Europe under an Early Access Program.
Early Access Programs allow biopharmaceutical companies to provide eligible patients with access to investigational medicines for unmet medical needs within the scope of the existing early access legislation. Access is provided in response to physicians' requests where other treatments have been unsuccessful and no alternative or appropriate treatment options are available to their patients.
PTCL is a form of lymphoma. Lymphoma is a cancer of the lymphatic system, which is part of the immune system. There are many types of lymphoma: one type is called Hodgkin's disease, and the rest are called non-Hodgkin's lymphomas (NHL). PTCL is classified as one of the many non-Hodgkin's lymphomas.
NHL affects two particular types of white blood cells: lymphocytes called B cells and T cells. PTCL occurs when T cells develop and grow abnormally. Usually, no one knows why a person develops PTCL.
There were an estimated 356 000 new cases of NHL and 192 000 deaths from NHL worldwide in 2008. NHL is the 8th most commonly diagnosed cancer in men and the 11th in women. The disease accounts for ∼5.1% of all cancer cases and 2.7% of all cancer deaths. Areas with highest incidence of NHL include North America, Europe, Oceania, as well as several African countries
10%-15% of all newly diagnosed cases of NHL will be identified as a type of PTCL.
Hence PTCL is a relatively rare but often aggressive type of non-Hodgkins lymphoma.
MyTomorrows is an online platform that is creating options for physicians and patients with unmet medical needs by offering earlier access to medicines that show promising results during clinical trials, but are not officially registered. With the support of their doctors, patients who suffer from cancer, a neurological disorder, a rare disease or a severe depression, may be able to gain earlier access to such medicines. For more information about myTomorrows, please visit the website http://www.mytomorrows.com.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a leading biotechnology company focused on acquiring, developing, and commercializing drug products, with a primary focus in hematology and oncology. Spectrum markets five hematology/oncology drugs, and expects an FDA decision on another hematology drug later this year. Additionally, Spectrum's pipeline includes three drugs targeting blockbuster markets in advanced stages of clinical development. Spectrum's strong track record in in-licensing and acquiring differentiated drugs, and expertise in clinical development have generated a robust, diversified, and growing pipeline of product candidates in advanced-stage Phase 2 and Phase 3 studies. More information on Spectrum is available at http://www.sppirx.com.