Tag: Avastin

Food for Thought: Trade Media Update

MedNous this week opens up with an article on FDA’s revoking the breast cancer indication for Avastin, saying that the decision did not come as a surprise after the FDA’s Oncologic Drugs Advisory Committee (ODAC) in June voted unanimously to have the indication removed. Avastin had been subject to FDA’s accelerated approval process in this indication.

In contrast, BioCentury Extra reports that FDA encouraged Genentech Inc to continue to study the drug in this indication to identify patients who may benefit and also details Genentech’s plans for Avastin in this indication. It also writes that in the previous months, the National Comprehensive Cancer Network (NCCN) continued to recommend Avastin as an option in breast cancer despite the negative ODAC vote.

The In Vivo Blog comments on the Avastin decision by saying that it introduced some predictability into the accelerated approval regulatory pathway. Companies should continue to use progression-free survival as a surrogate endpoint but not forget to that FDA has some expectations, e.g. for quality of life benefits, and that sponsors should design trials with supportive measures that can themselves turn into additional claims.

BioCentury this week in its cover story reports on the next-generation, interferon-free treatment regimes for HCV which have been in the focus of the recent Liver Meeting of the American Association for the Study of Liver Diseases (AASLD), stating that the new standard of care introduced only this year  following the approval of two HCV protease inhibitors, may be supplanted quickly by new regimes that are tailored to virus subtypes and patient populations.

SciBx is focusing on novel small molecule inhibitors of Monoacylglycerol lipase (MAGL), which regulates the levels of several compounds that signal through the endocannabinoid pathway. However, now that researchers have shown that it MAGL inhibitors reduce neuroinflammation, there is increased interest in the industry in these inhibitors. MAGL also is explored as a cancer target as reported by Derek Lowe in its “In the Pipeline” blog.

SCRIP this week deals with plans of the French health ministry to collect more than €290 million for the pharmaceutical industry in 2012 to reduce health care spending. In addition, it reports on plans to widening the tax on pharmaceutical industry promotion.In its editorial, SCRIP focuses on German media trying to scandalize the deaths attributed to Boehringer Ingelheim’s Pradaxa drug (see the akampioneer).

Food for Thought: Simply Obscene

In a recent article (“Simply Obscene”) the influential German news magazine “Der Spiegel” (20/2010, May 17, 2010) stated the pharma industry was using “with the unscrupulousness of a stock jobber” a loophole in Germany’s highly regulated health care system to charge extremely high prices for basically useless cancer medications. In particular, the article featured Yondelis by Pharma Mar, Nexavar by Bayer, Hycamtin and Tyverb by GlaxoSmithKline, Erbitux by Merck KGaA, Sutent by Pfizer, Iressa by AstraZeneca, Avastin, Xeloda, Mab-Thera and Herceptin by Roche and Alimta by Lilly as examples for cancer drugs providing only marginal survival benefits at enormous costs and stated this was “lawful looting of the health care system”.  The only exception according to the authors of the article was Novartis’ Gleevec.

This week, the Competence Network Malignant Lymphomas published an open “letter to the editor”  (only available in German) stating that in the case of lymphoma therapy the authors of the article had done “obviously sloppy work”: “Therapy costs of lymphocyte-specific antibody Rituximab [MabThera] amount to €24,000, not €134,000 per year. Several independent studies have demonstrated that overall survival in both follicular and diffuse large B cell lymphoma is prolonged on average by several years (!), in fact without substantial side effects.” Der Spiegel had stated extension of survival in these two indications was “not proven”.

The letter also said that administrative costs for studies to optimize therapies had increased by a a factor of 10 in the last couple of years due to legal requirements.

The article of Spiegel magazine is available online in German, however without the tables featuring treatment costs and extension of survival for the drugs mentioned.