I have read the note and it has it's issues(main worry is hyperbole). However, although it might be a small survey, these appear to be some high volume CML docs, so dont think they would overstate things(unless Favus is doing that).
I would be worried if some of these anecdotal comments on AEs were true and show up in the FDA's AE reporting service.
Below is the note for those wondering
"What’s New: We are awaiting an FDA response to our request for the first set of Iclusig serious adverse events since US approval. We got impatient, so this week we performed a survey of US oncologists who use Iclusig in CML. While we planned to include 30 oncologists; we have taken the unusual step of stopping our survey early because we found a large number of serious adverse events that are not consistent with frontline CML use. Since many patients take the same CML drug for years, tolerability is an important issue for patients and oncologists. Our summary findings are:
1. Our survey includes 13 oncologists who are treating approximately 840 CML patients and have used Iclusig in 77 patients since FDA approval in December, 2012. Of the 77 patients treated with Iclusig, 39 patients (51%) were rollover patients from the continued-access program, and 10 patients (13%) have already stopped taking Iclusig (suggesting a rapid drop-out rate).
2. Serious side effects include non-reversible significant liver toxicity, pancreatitis, severe acute hypertension, heart attack, stroke, TIA, digital ischemia, and gastrointestinal perforation (Figure 6 & 7).
3. Our small survey found 26 patients on Iclusig who had abdominal pain that required medical attention/evaluation and 21 patients who developed pancreatitis.
4. Iclusig is getting pigeon-holed as the drug for T315I mutation (extremely rare), while Bosulif has a broader appeal in heavily pre-treated CML (Figure 11). This use pattern is different from ARIA’s recent description of the US launch.
5. Oncologists report that ARIA’s Iclusig sales pitch (Figure 12) emphasizes the safety profile and duration of responses; both issues appear at risk just a few months into the US launch. Oddly, ARIA salespeople are mentioning the ongoing frontline trial of Iclusig versus Gleevec; while not illegal, we fail to see how this fits into on-label sales activities.
6. Oncologists in our survey report using Bosulif in 32 patients since FDA approval in September, 2012; only one patient was on the continuing-access program.
7. Negative on discontinuation trials, positive on generic Gleevec: 70% of oncologists in our survey do not expect treatment discontinuation to become a viable strategy in CML, or believe it will be applicable for only a small number of patients. Recall that a bull argument among ARIA holders is that frontline treatment with ponatinib will provide deep responses in CML, which creates an opportunity for treatment discontinuations. The oncologists in our survey expect frontline Gleevec use to rise in 2015, when Gleevec goes generic in the US.
Our View: The more we learn about Iclusig, the less it appears to be a frontline CML drug. As the number of cases of liver toxicity, pancreatitis, abdominal pain, severe acute hypertension, heart attack, stroke, TIA, digital ischemia, and gastrointestinal perforation rise, investors’ faith in Iclusig will fall, and so will the price of ARIA shares. Iclusig has a very small role to play in heavily pre-treated CML patients with the T315I mutation (extremely rare); as time goes on, that observation is becoming obvious. Don’t be the last to know…"
AI
