All GLG News Analyses Filed Under: Oncology

GlaxoSmithKline has gained a complete response letter from the U.S. Food and Drug Administration related to its application for the cervical cancer vaccine, CERVARIX®. This likely means approval is 2-4 weeks away, but it could also mean months to years.

Innate immunity offers exciting new science.  Idera following Coley and Dynavax. Presumably room for improvements in specificity and stability. Animal data impressive but too early to tell if there is a significant clinical benefit. 

Roche received approval for Avastin plus interferon (IFN) in advanced RCC

A phase I/II trial of a heat shock protein 90 (Hsp90) inhibitor is being tested in patients with and without an Epidermal Growth Factor Receptor (EGFR) mutation that "sensitizes" the lung cancer cells to some targeting agents.

sutent reports higher cardiac toxcicity than other RCC choices

We already have a very good vaccine on the market. The GSK vaccine does not give as good coverage overall. The FDA letter will add questions as to what is not so good about this vaccine.

Pfizer's sutent cased moderate to severe cardiac toxicity in a study involving 75 patients who all had normal cardiac function at study entry. This relatively high rate of adverse events will push physicians more towards prescribing Nexavar ( Bayer/Onyx)  and Torisel (Wyeth) in patients...

sutent has first line data supporting it's use in advanced REnal Cancer Sutent's cardiac problems, mainly CHF, will cause drug to loose market share Other TKI's and biologics of different actions will advance

In one study 11% of an admittedly small group of patients developed cardiac problems.

Avastin has demonstrated PFS in first line metastatic breast cancer Avastin remains in a non approved status for breast cancer Avastin is very expensive and therefore scrutinized to the max