GLG News by Taral Patel, MD

Implications: New data with low and high dose of Avastin with Taxoter

Analysis: FDA may need more time to review new data with Taxoter+avastin.
I think Genetech will get FDA aprovable letter.
But AVADO trial Low dose has same PFS as high dose.

Implications: esults showed that PROVENGE patients experienced improved survival if they received more cells across the three doses of PROVENGE (higher cumulative TNC count (p=0.019)) or higher cumulative CD54 upregulation values (p=0.009). The effect on survival for TNCs appeared to reflect in part the patients' baseline prognostic factors. However, the CD54 upregulation ratio appeared to be an independent predictor of survival in patients who received PROVENGE, as the correlation remained strong even after adjusting for baseline prognostic factors (p=0.022). Data is very impressive. This may lead FDA approval in prostate cancer in next 3-6 months.

Analysis: Data is very impressive.
This may lead FDA approval in prostate cancer in next 3-6 months.

Implications: “On face value the data look very good,” said Buzdar, who voted with the slim (5-4) majority against the drug. In the study that was the basis of Genentech’s application, Avastin appeared to slow the progress of the disease. advanced breast cancer who had already tried other drugs. He said he’s never used Avastin to treat breast cancer, but he knows other doctors do, despite the lack of FDA’s blessing. “Physicians always want to do something for the patient,” he said. But he believes the panel’s vote “will make them think twice” before they try Avastin for breast cancer. “This drug is a good drug,” Buzdar added. “It does work in a number of other cancers where it not only prolongs control of the disease but it keeps more patients alive. In breast cancer, it has not panned out.”

Analysis: Most of oncologist on FDA ODAC pannel voted yes except one.
Other No votes are from persons who is not a physcian.
FDA  still can approved Avastin in breast cancer. But probabilty is very low.
Avastin is approved in Europe for last 18 month on same data.
In my opinion Avstin may get conditonal approval in Feb 2008

Implications: CMS is doing right thing. This will aviod pt fall and bedsore during hospitalzation

Analysis: CMS is doing right thing. This will aviod pt fall and bedsore during hospitalzation. It will improve quality care.

Implications: The comprehensive clinical program will supplement the significant body of clinical data existing for ERBITUX in colorectal and head and neck cancers by exploring the use of ERBITUX in additional tumor types including brain, breast, bladder, gastric, lung, pancreas and prostate

Analysis: Since erbitux fail to show significant improvement in colon cancer.
I am not sure erbitux will be effective in any orhter cancer except Head and neck

Implications: The coverage restrictions placed on the FDA-approved indication have no scientific basis and are incompatible with good clinical practice," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Global Research and Development at Amgen. "We are concerned that inappropriately limiting coverage for ESAs at hemoglobin levels less than 10 g/dL will both increase blood transfusions and severely compromise the high quality of cancer care delivered by American physicians. In our view, restricting coverage in this way is unreasonable, impractical and unworkable. Moreover, through this coverage decision, the CMS has undermined the ability of physicians to decide how best to administer ESA therapy to their patients through carefully defined dosing guidance articulated by the FDA."

Analysis: Medicare lae required to cover all treatment approved and indicated by FDA. This new ESA ruling violating this law. Amgen and orthobiotech may challange in court.

Implications: My understading id medicare need to cover all FDA indicated drugs. Here CMS violating FDA indication for Aranesp and procrit

Analysis: who has more power?
FDA or CMS

Implications: Decrease use by 20-25% use of ESA. This may lead discounting and higher rebate from both amgen and orto-biotech to sustain market share. Since most of amgen contract with aranesp and neulasta use. It may effect use of neulasta. Next 6 month CMS may restrict use of Neulasta and neupogen for neutropenia associated with chemotherapy.

Analysis: Decrease use by 20-25% use of ESA. This may lead discounting and higher rebate from both amgen and orto-biotech to sustain market share. Since most of amgen contract with aranesp and neulasta use. It may effect use of neulasta. Next 6 month CMS may restrict use of Neulasta and neupogen for neutropenia associated with chemotherapy.