pharma

Bristol-Myers, ImClone, Genentech Release Promising Data at ASCO

AX,

"Also we must not forget that when Mike Huckman asked at the ASCO the doctors if they would prescribe Erbitux to their patients the vast majority said yes. And the one that wasn't sure was from Canada."

It is important to mention that Erbitux is not available in Canada. Bristol (who does Erbitux marketing in North America) is still negotiating with Canadian government Erbitux's price sold there.

Bristol-Myers, ImClone, Genentech Release Promising Data at ASCO

Half-truth is bad. It is more bad than lies. But this is exactly what Jason Napodano provides his readers.

Yes indeed, in general ITT [intend to treat] patient population adding Erbitux to chemotherapy extended the overall survival rate to 11.3 months from the 10.1 months for chemotherapy alone.

But this is not the entire story. Flex trial patients population included substantially broader spectrum of patients than the Avastin trial Jason Napodano has mentioned.

So let compare apples with apples:

- the Avastin trial #E4599 was conducted exclusively in Adeno-ca lung cancer patients. Addition of Avastin to chemotherapy improved median survival rates from 10.3 months to 12.3 months. Furthermore, cancer patients in Avastin #E4599 trials were ECOG 0-1 [relatively "healthy" patients] compare with more sick FLEX patients with ECOG 0-2.

In these more sick Adeno-ca lung cancer patients, addition of Erbitux to chemotherapy improved median survival from 10.2 months to 12 months. FLEX Erbitux median survival benefits to more difficult to treat lung cancer patients were practically identical to Avastin.

- But it is not all. FLEX ITT patient population also included SCC- lung cancer patients. These cancer patients can NOT be treated by Avastin due to severe life-threatening side-effects. In this lung cancer population, addition of Erbitux to chemotherapy improved median survival from 8.9 months to 10.2 months.

- It is true, Erbitux did not work on Asian patients. Addition of Erbitux to chemotherapy reduced these patients median survival. Erbutux should not be used in Asian lung-cancer patients.

- Avastin and Erbitux belong to two different classes of drugs. Erbitux is a EGFr-drug. It offers substantial clinical benefits to only a select group of patients and no benefits to the rest. By identifying Erbitux-responding patients [like it is done using biomarkers in colorectal cancers], survival benefits offered by Erbitux are much superior to Avastin benefits.

- Finally, the latest Avastin clinical trials in lung cancer failed to show survival benefits. Consequently, effictiviness of Avastin in lung-cancer became an issue.

Genentech's Avastin: An Undeserving Target for Politicians and the Media

Panel Recommends Against Avastin for Breast Cancer
Final FDA Decision Still to Come

Report from official American Cancer Society website
Article date: 2007/12/07

An advisory panel for the US Food and Drug Administration (FDA) says the drug Avastin (bevacizumab) should not be approved for breast cancer treatment.

The Oncology Drug Advisory Committee recommended against FDA approval by a 5-4 vote Wednesday, noting that Avastin does not help breast cancer patients live longer and can cause severe side effects.

Avastin is approved to treat colon cancer and lung cancer. Studies have shown that Avastin helps patients with these cancers live longer.

Survival Not Significantly Improved

In making its recommendation, the advisory panel reviewed the results of a clinical trial involving 722 women with breast cancer that had returned after initial treatment or that had spread to other parts of their body. The women were randomly assigned to receive either Avastin plus the chemotherapy drug paclitaxel, or paclitaxel alone.

Adding Avastin to paclitaxel kept the cancer from growing for an average of 11.3 months, compared to 5.8 months for the women getting paclitaxel alone.

But overall survival was not significantly better, and women who received Avastin had more serious side effects compared to those who got paclitaxel alone. Those included high blood pressure, blood clots, heart problems, holes forming in the colon (bowel perforation) and high levels of protein in the urine, which is a sign of kidney damage. These are all known side effects of Avastin.

In a report prepared for the panel, the FDA also said Avastin treatment may have caused as many as 6 deaths.

Genentech's Avastin: An Undeserving Target for Politicians and the Media

"The results of the large adjuvant CRC trials are expected to show prolonged survival and those results are expected late 2008/early 2009."
These are just speculations. Such data are not available yet.

Now, speaking about Avastin in breast cancer patients.

"The original vote of 5-4 against was reported to have privately been changed to a 6-3 vote for approval as one of the members of the temporary panel - an oncologist from MD Anderson - and a patient advocate changed their votes. "
I am wonder what kind of "private incentives" were offered to the panel member to change his vote? It were not new data since getting ones would take many months.

The most important fact is that Avastin does NOT offer any survival benefits to breast cancer patients!

PS
"What about the people in poor countries who too get cancer but cannot afford this price? Someone has to ask these questions."
Too bad but nothing can be done about it. Any new drug development [if successful since 9 iout of 10 will fail] cost close to $1B, and somebody must pay for it.