Sutent now a first line therapy for RCC in Europe

Wyeth's Torisel granted priority review

The first mTor inhibitor has been granted priority review. Approval is requested for RCC, which puts it in direct competition with Nexavar and Sutent. As Torisel is fast-tracked, performance is likely impressive and perhaps superior. I wonder if Onyx/Bayer or Pfizer is already talking to Wyeth about conducting combination trials.

TT: patient base expands beyond payment capacity?

According to a new report from Decision resources: "targeted cancer therapies are expanding the oncology market by increasing the age limit for treatment....., more than 80% of oncologists say that the availability of targeted cancer therapies is increasing the number of elderly patients who they treat; 64% of these respondents state that the increase is due to fewer side effects associated with targeted agents compared with chemotherapy.

Hmm....time to expand those market projections

But....

Access is an emerging problem:

"Nearly one-fifth of office-based oncologists are planning to limit treatment of Medicare patients in the next 12 months.

Office-based oncologists report that 16% of their Medicare patients who are candidates for targeted therapies fail to undergo treatment for cost- related reasons, most frequently because the patient cannot afford the copayment or coinsurance," said Mary Argent-Katwala, Ph.D., analyst at Decision Resources. "The extent of this problem varies between therapies: oncologists estimate that 10% of eligible patients fail to receive Avastin because patients cannot afford the copayments or because the drug is not available on the formulary for the desired use; for Sutent, the corresponding figure is 52%."

Wow.


2 issues:

Reimbursement: I wonder if the difference in uptake between Sutent and Avastin is largely explained by Avastin's ~15 month earlier FDA approval, meaning that the drug has had enough time to be added to most formularies. (Or is it the difference between options available to treat CRC (Avastin) vs RCC (Sutent.))

Patient opt-out for treatment based on $$$: I'd be real curious to know if this is an example of patient self-rationing (i.e. they don't see a good cost/benefit return for Avastin or Sutent extending life by a few months), or, is this a consequence of American's poor savings habits, as there is interest in treatment, but no cash available?

Cancer kinase inhibitors for hypertension too?

Researchers believe that Nexavar (competitor to Sutent) may prevent pulmonary hypertension, in addition to its’ anti-cancer properties. (The article doesn’t state which target Nexavar blocks to counter hypertension.)

It’s been long talked about that cancer and inflammation are linked diseases, with some even suggesting that they’re the same disease (and managed by IKK kinase), so the Nexavar finding isn’t shocking, but it’s most important implication may be an extended application for this class of drug.

In spite of this news, stock in Onyx (Nexavar's maker) dropped 1.8%. I still think Onyx is a buy, as I detailed here:

http://cogentpassion.blogspot.com/2006/06/i-bought-onxx-onyx-pharm.html

Nexavar vs. Sutent

Onyx just posted 3Q results. Nexavar sales rose 41% to $45M for the quarter versus $63M and 75% growth by Sutent over the same period. (Pfizer also notes 7,500 Sutent patients vs. 6,000 last quarter.)

It's probably too early to declare a winner (the winner may be determined by who does the best, quickest job expanding the label), but Sutent (Pfizer) almost doubled Onyx/Bayer's new revenue for the quarter.

I suspect that Onyx stock may take a hit based on the comparison to Sutent, but these figures actually put Onyx on track to surpass '06 Nexavar sales. A good 4th quarter with 33% growth to $59M would put Nexavar '06 sales in excess of $160M. I'm pretty sure that consensus estimates were around $140M.

Sutent results really look strong, especially considering that Pfizer has a not-yet-mature oncology sales force.