Sutent

NICE to green-light costly kidney meds

Tracy Staton — Mon, 01 Dec 2008 11:20:07 -0500

A much-lamented ban on new kidney cancer drugs in the U.K. will soon be lifted, the Guardian reports. Of four meds that the National Institute for Health and Clinical Excellence called too expensive for National Health Service use, at least half will be approved--and perhaps all four, the paper writes.

As you know, NICE recently ruled that Pfizer's Sutent, Bayer's Nexavar, Wyeth's Torisel, and Roche's Avastin didn't ace the cost-benefit analysis all NHS drugs are expected to pass. According to NICE's calculations, the drugs were too costly for the additional survival time kidney cancer patients tended to experience when using them. Patient advocates immediately pounced, and a public outcry ensued.

Now, however, sources are telling the Guardian that NICE will OK Sutent next month, when a committee meets to discuss the drugs again. Either Avastin or Nexavar is likely to get the nod, too, the sources said.

This turnabout by NICE follows some pricing negotiations between the agency and drugmakers. The companies have offered some new pricing schemes for the meds, including discounts and risk-sharing.

- read the Guardian story
- see the post at Pharmalot

NICE rejects four cancer meds

Tracy Staton — Thu, 07 Aug 2008 10:16:02 -0400

The debate over costly oncology meds rages on in the U.K. as the National Institute for Health and Clinical Excellence rejected four high-tech drugs for advanced kidney cancer treatment: Sutent (Pfizer), Avastin (Roche), Nexavar (Bayer) and Torisel (Wyeth). NICE acknowledged that the drugs do extend life--by up to six months--but concluded that the money would be better spent on other patients.

The decision drew immediate fire, not only from patient advocates, but from cancer researchers and doctors, too. One doctor said there was no point in accepting referrals for advanced kidney cancer patients without those drugs, because most don't respond to the only other alternative, interferon.

The outcry might actually have some effect: NICE initially rejected Herceptin outright for breast cancer treatment, then relented after receiving an outpouring of complaint. The agency's final kidney cancer treatment guidance will come through in January.

- read the story in the Times
- check out the Telegraph's coverage

Genentech profits clouded by failed trial

Tracy Staton — Tue, 15 Jul 2008 10:11:49 -0400

Yesterday was a good news, bad news sort of day for Genentech. Sales of its cancer blockbusters Avastin and Rituxan drove second-quarter profits up almost 5 percent year-over-year, but the results still didn't meet Wall Street forecasts. And though the company raised its full-year earnings forecast, it had to stop a three clinical trials when the treatment--in combination with Pfizer's Sutent--induced anemia in some patients.

The second-quarter earnings details: Revenues hit $3.24 billion, up from $3 billion a year earlier, and profits ran at $782 million compared with $747 million. Avastin sales reached $650 million for the quarter, up 15 percent year-over-year, and Rituxan sales were up 12 percent to $651 million. The revenue figures satisfied analysts, but at 73 cents, earnings per share disappointed; the Street had expected 86 cents.

Now, about Avastin. Currently FDA-approved for treating breast, lung, and colorectal cancers, Avastin isn't approved for use in combination with Pfizer's Sutent. The company had been running a Phase II trial on the combo. Yesterday, the FDA announced that patients had developed microanegiopathic hemolytic anemia during that study, and Genentech halted it and two others looking at Avastin in combination with Sutent. The anemia cases resolved themselves within three weeks after the patients stopped using both meds.

- find the FDA alert on Avastin
- see the earnings basics in the New York Times
- check out the Wall Street Journal's take
- read the Forbes story