NorthWest Biotherapeutics Inc (NWBO)

[AVII77]

Three studies show adding Avastin to Lomustine in rGBM or TMZ in nGBM increases the chance of death for patients under 50 years of age, and yet it is approved in combination with Lomustine to treat rGBM, and this, according to Genentech's/Roche's own approval study for rGBM increases the risk of death by 61% in that patient population.

It may actually be worse than that Flipper.

From a safety signal perspective you look at the upper bound of that 95% CI.

HR = 1.61 (0.96 : 2.70)

The point estimate is a 61% increased risk of death. But with this data you can't rule out up to a 2.7 fold increased risk of death in rGBM patients under 50 treated with Avastin.

(and to put this in perspective you probably know that for diabetes drugs, the FDA requires them to assess CV risk. They need to show that upper bound is below 1.8 (up to 80% increased risk) at the time of initial approval and conduct a post approval CV safety study showing the upper bound for CV Risk is below 1.3. Cancer is not diabetes, but it seems appropriate to include this on the label if deemed a potential safety signal observed across multiple trials)