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Antisoma's AS 1409 has just entered a clinical phase I trial for patients with advanced melanoma and renal cancer. While efficacy results are years ago, this "immunotherapy" will be competing with many approved targeted agents in renal cancer ( Sutent, Nexavar, Torisel) and with many other immunotherapeutic...
the "Record" trial showed that Novatis' m-Tor inhibitor, everolimus improved progression free survival as compared to placebo in patients with advanced renal cancer who failed several other therapies including Avastin ( Genentech), Nexavar ( Bayer) and/or Sutent ( Pfizer). With The field of targeted...
Merck's HPV vaccine, Gardasil is expected to be approved for boys to extend "herd immunity" and offer more prevention to girls from cervical cancer. This " altruistic" goal comes with benefits for boys: eradication of 90 % of genital warts cases, and possible long term prevention of anal , penile, and...
As expected, FDA gave accelerated approval for Genetech's Avastin in metastatic breast cancer, thus requiring Genentech to do further studies to show survival benefit and confirm the PFS survival. This decision will "officially" introduces Avastin to breast cancer market, where use has been already...
Treanda (Bendamustine) combines the activity of a purine analog and alkylating agent, two of the most potent cytotoxic classes in therapy of indolent NHL. Older data from Europe as well as more recent clinical trials have confirmed the excellent activity of Treanda in indolent NHL and CLL. ...
Cephalon's Treanda have shown efficacy in relapsed/refractory indolent NHL and also in CLL, and is expected to get FDA approval for both indications. Cephalon currently has FDA approval for Trisenox for relapsed APL ( a less common form of AML) and is developing Lasteurinib for FLT-3 positive...
Avastin is often used for the treatment of stage IV breast cancer. Based on compendia listing and published data, Avastin prolongs DFS when given in combination with a Taxane as initial breast cancer therapy. However, this market share ay be jeopardized if the FDA fails to approve Avastin...
Historically , FDA follows the recommendations of its advisory committee, in this case to reject approval of Avastin. This is an election year but breast cancer patients and their families are strong activists, not to mention Genetech's mighty connections , so approval with restrictions , especially...
Several agents have recently received FDA approval for the treatment of renal cell carcinoma including Sutent, Nexavar and Torisel. The recent study describes a 15% rate of cardiovascular toxicities in patients receiving Sutent including heart failure. Y+This is a higher rate than...
Avastin faces a substantial hurdle when it goes before the FDA for approval in first line breast cancer therapy. There has been much debate over the progression free survival benefit (5.5 months) but no overall survival benefit for this agent. The newly reported European data on Avastin...