Showing posts from January, 2018

FDA approves expanded use of AstraZeneca cancer drug

The U.S. Food and Drug Administration said on Friday it has approved expanded use of AstraZeneca Plc’s cancer drug Lynparza to include patients with metastatic breast cancer whose disease is associated with a mutation of the BRCA gene. The drug belongs to a class of drug known as PARP inhibitors that has already been used to treat advanced BRCA-mutated ovarian cancer, the FDA said. This is the first time a PARP inhibitor has been approved to treat breast cancer and the first time any drug has been approved to treat certain patients with metastatic breast cancer associated with the same genetic mutation. “This approval demonstrates the current paradigm of developing drugs that target the underlying genetic causes of a cancer, often across cancer types,” said Dr. Richard Pazdur, head of the FDA’s oncology products division. Between 5-10 percent of patients with breast cancer have a BRCA mutation. Patients are selected for treatment based on a diagnostic test made by Myriad Ge

Biocon, Sandoz to develop next-gen biosimilars in immunology, oncology

Biocon has partnered with Sandoz, a Novartis division and a leading player in biosimilars, to develop, manufacture and commercialise multiple biosimilars in immunology and oncology for patients worldwide. According to the deal, both companies will share responsibility for end-to-end development, manufacturing and global regulatory approvals for a number of products and will have a cost-and-profit share arrangement globally. They did not divulge specifics but said that worldwide commercialisation responsibilities will be divided with Sandoz leading commercialisation in North America and EU, while Biocon will lead commercialisation in the rest of the world. Biocon Chairperson and Managing Director Kiran Mazumdar-Shaw, said: “This synergistic partnership will enable us to scale up our capabilities for an ‘end-to-end’ play in the global biosimilars space. We remain committed to pursue our mission of developing biopharmaceuticals that have the potential to benefit a billion patients

Key anti-cancer drug Erubulin to be affordable now

A landmark  breast cancer  drug that so far remained out of reach of underprivileged patients in the country is set to become affordable in the coming months. Hyderabad-based Indian Institute of Chemical Technology (IICT) has developed the technology, which will enable pharma companies develop a generic version of the top anti-breast cancer drug Erubulin and launch it in the Indian market in the coming months this year. Approved in 50 countries worldwide for extending the life of patients struggling with advanced and aggressive breast cancer for a long time, Erubulin was out of reach of women hailing from families with limited financial resources. IICT has already identified a pharmaceutical company which will launch the generic Erubulin drug in the coming months. An announcement to this effect is expected to be timed with the Platinum Jubilee Celebrations of the research institute to be held around August this year. Breakthrough The team of researchers from IICT led by its

FDA Approves First Radioactive Drug for Rare Type of GI Cancer

The FDA Friday approved the first radioactive drug, or radiopharmaceutical, to treat a rare type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Lutathera (lutetium Lu 177 dotatate) is cleared for adult patients with somatostatin receptor-positive GEP-NETs. GEP-NETs are a rare group of cancers with limited treatment options after initial therapy fails, said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. GEP-NETs can be present in the pancreas and in different parts of the gastrointestinal tract such as the stomach, intestines, colon and rectum. It is estimated that approximately 1 out of 27,000 people are diagnosed with GEP-NETs per year. Lutathera is a radioactive drug that works by binding to a part of a cell called a somatostatin receptor, which may be pres