Monthly Archives: February 2012

The FDA is importing two drugs, including Doxil, to ease a shortage of these critical treatments. (Ricardo DeAratanha/Los Angeles Times) Reuters 9:30 a.m. CST, February 21, 2012 The Food and Drug Administration is addressing the U.S. shortage of critical cancer medications by importing one drug from abroad and rushing the approval of another. The move announced Tuesday is the latest government effort to stem the shortages of drugs in the United States, which doctors and patient advocates say have forced providers to postpone care or use second-best or costlier alternatives. The FDA said it would allow cancer drug Doxil to get shipped from abroad and also approve a new manufacturer of methotrexate, a drug used to treat childhood leukemia. Doxil, a cancer drug from Johnson & Johnson, has been in persistent short supply since manufacturing problems surfaced at a plant of Ben Venue, a unit of German drugmaker Boehringer Ingelheim. The injectable drug, which has annual global sales of about $500 million, is used to treat ovarian cancer and multiple myeloma. The plant's problems also have contributed to a shortage of methotrexate, leading U.S. lawmakers to call for action last week from the FDA and the manufacturers. President Barack Obama … Continue reading →

DUBLIN--(BUSINESS WIRE)-- Research and Markets (http://www.researchandmarkets.com/research/324666/targeted_cancer_dr) has announced the addition of the "Targeted Cancer Drugs The Launch Landscape to 2018" report to their offering. As the cancer therapy market evolves, interest is growing in novel approaches which may supersede the current portfolio. In the short term, the market will be dominated by established therapeutic approaches, but the question is - What next? A Sign of Things to Come? The end of 2011 saw the US approval of two new molecularly-targeted cancer drugs, alongside companion diagnostic tests that identify the patients most likely to benefit from treatment. Pfizer's Xalkori (crizotinib) and Roche's Zelboraf (vemurafenib) were both approved following a priority review, highlighting the importance that the FDA has placed on hastening the passage of these therapies to market. These approvals reflect the trend of treating cancers based on their molecular and genetic characteristics, rather than their location within the body. Such developments have long been heralded as marking the future of cancer therapies and the benefits to patients, clinicians and health payers is clear -but are these approvals the benchmark for future developments? With sales of many blockbuster drugs being cannibalised by generic competitors, pharmaceutical and biotechnology companies are populating their … Continue reading →

(Reuters) - The Food and Drug Administration plans to address a potentially life-threatening shortage of two leading cancer drugs by allowing one of them to be imported from abroad and rushing approval for a new manufacturer to make the second. The move announced on Tuesday is the latest government effort to stem the shortages of drugs in the United States, which doctors and patient advocates say have forced providers to postpone care or use second-best or costlier alternatives. The FDA will allow imports of a version of the cancer drug Doxil, which, in the next few weeks, should meet patient needs, the agency said. The drug version is called Lipodox and has the same active ingredient as Doxil, doxorubicin. The FDA will also approve a new company, APP Pharmaceuticals, to make methotrexate, a drug used to treat childhood leukemia. APP is a unit of German healthcare group Fresenius SE. Doxil, a cancer drug from Johnson & Johnson, has been in persistent short supply since manufacturing problems surfaced at a plant of Ben Venue, a unit of German drugmaker Boehringer Ingelheim. The injectable drug, which has annual global sales of about $500 million, is used to treat ovarian cancer and multiple … Continue reading →

It's personal now: Alexis Borisy (left) and Michael Pellini lead an effort to make DNA data available to help cancer patients. Credit: Christopher Harting Michael Pellini fires up his computer and opens a report on a patient with a tumor of the salivary gland. The patient had surgery, but the cancer recurred. That's when a biopsy was sent to Foundation Medicine, the company that Pellini runs, for a detailed DNA study. Foundation deciphered some 200 genes with a known link to cancer and found what he calls "actionable" mutations in three of them. That is, each genetic defect is the target of anticancer drugs undergoing testing—though not for salivary tumors. Should the patient take one of them? "Without the DNA, no one would have thought to try these drugs," says Pellini.  Starting this spring, for about $5,000, any oncologist will be able to ship a sliver of tumor in a bar-coded package to Foundation's lab. Foundation will extract the DNA, sequence scores of cancer genes, and prepare a report to steer doctors and patients toward drugs, most still in early testing, that are known to target the cellular defects caused by the DNA errors the analysis turns up. Pellini says … Continue reading →

TUESDAY, Feb. 21 (HealthDay News) -- The U.S. Food and Drug Administration announced Tuesday what it called a series of steps to ensure the continued availability of vital cancer drugs that have been in dangerously short supply. One of the drugs, methotrexate, is used in combination with other drugs to combat -- and in many cases cure -- acute lymphoblastic leukemia (ALL), the most common type of cancer in children. It typically strikes kids aged 2 to 5. And another drug, Lipodox, will be temporarily imported from a pharmaceutical company in India to ease a shortage of the chemotherapy drug Doxil (doxorubicin), which is used to treat ovarian cancer, multiple myeloma and AIDS-related Kaposi's sarcoma. Lipodox is similar in chemical makeup to Doxil; there are no generic versions of Doxil. "Through the collaborative work of [the] FDA, industry and other stakeholders, patients and families waiting for these products or anxious about their availability should now be able to get the medication they need," FDA Commissioner Dr. Margaret A. Hamburg said in a news release. The FDA also said it was issuing guidelines to the drug industry that spell out detailed requirements for "both mandatory and voluntary notifications" to the agency … Continue reading →