Replies to post #149468 on Biotech Values

[mcbio]

After the problems with Avastin using PFS in breast cancer, aren't regulatory authorities going to take a very hard look at Avastin using PFS in another cancer indication?

Apparently not EU authorities given the CHMP recommendation. To be fair, I think the ovarian cancer patients being targeted here are much more of an unmet need.

[jq1234]

Avastin hasn't got approval in Ovarian cancer in US because OS data aren't there. EMA is always willing to approve based on PFS. But they have different system, member states decide reimbursement on their own. Approval with PFS doesn't mean reimbursement. They need to support additional data for cost benefit analysis to each member state to get reimbursement.

Look at CRME's Vernakalant, FDA declined to prove it, EMA did, but it doesn't get much if any revenue there despite approval. It is a lot harder to get reimbursement than approval in EU.

[masterlongevity]

probably at the FDA yes, which is why they are waiting on OS.

But you also have to remember that PFS avastin benefits translated to OS in colorectal, lung, renal, etc.

[DewDiligence]

Avastin hits PFS/misses OS in phase-3 trial in first-line glioblastoma:

http://finance.yahoo.com/news/genentech-study-showed-avastin-helped-154500206.html

The trial design was Temodar+radiation +/- Avastin; the HR for PFS (as measured by the trial clinicians) was 0.64 (p<0.0001).

Although the OS data are still maturing, they almost certainly won’t be statsig; at the most recent checkpoint, the HR for OS was 0.89 (p=0.21).

The one-year survival rate, a secondary endpoint, also missed being statsig (barely): 72% for the Avastin arm and 66% for the control arm (p=0.052).

Curiously, the HR for PFS as measured by a central committee was 0.61—slightly better than the HR measured by the clinicians. (This is the opposite of the usual outcome when dual evaluations are conducted.)