Finding Important Bio-Markers for Approved and Failed Drugs – Efficacy Improved and An Extended Life Rolled Up In One

Satraplatin is an oral platinum drug that is believed to bind the DNA of the cancer cell, which then prevents the cancer from being able to reproduce. Satraplatin had been tested in a phase III trial in men with metastatic castrate-resistant prostate cancer (mCRPC) who have failed chemotherapy with docetaxel. It failed because it did [...]

Discovery & Challenge: The State of Prostate Cancer Research A Roundtable Discussion with Leading U.S. Experts

Our own Alvin Chin, Prostate Cancer Survivor & Advocate, Virginia Prostate Coalition, joins oncologists Howard Scher MD, Donald S. Coffey, PhD, Peter S. Nelson, MD and representatives from research and the Pharma industry for a round table discussion April 23. You can make your voice heard by joining the conference by phone and emailing questions [...]

Malecare Provides Comments to Dr. Torti, the new Acting Director of the FDA

Last Friday's post included information about the recent appointment of Dr. Frank M. Torti as the Acting Director of the FDA. Dr. Torti has invited public comments about the future direction of the FDA. As a representative of Malecare, I have provided specific feedback to Dr. Torti. The following post includes my comments to him. [...]

Wall Street Journal – A Burden of Proof for Cancer Drugs

Today’s Wall Street Journal (8-2-07) had a front-page piece entitled Burden of Proof: Cancer Drug Fails, So Maker Tries New Pitch. Geeta Anand of the Wall Street Journal wrote it. The story is about Garo Armen and the biotech company, Antigenics Inc., which he founded 12 years ago and at a cost of 300 million [...]

Satraplatin Gets Delayed

Yesterday, I traveled to the Oncologic Drugs Advisory Committee (ODAC) for the U.S. Food and Drug Administration (FDA) where they reviewed the application for approval of Satraplatin (see my prior posts). The committee voted 12-0 recommending that the FDA delay the approval until all of the final survival data from the SPARC trial becomes available. [...]

URGENT – Register to Provide Public Comments at the FDA Hearing for Satraplatin

On May 15th I wrote about an application to the FDA for approval of a new treatment Orplatna, trade name of Satraplatin. This hearing, in front of the Oncologic Drugs Advisory Committee (ODAC) is scheduled for July 24 with the session to begin at 1 p.m. Open public comment is projected to begin at 3 [...]

ODAC to Review the Application for Satraplatin on July 24, 2007

Spectrum Pharmaceuticals announces that the FDA's Oncology Drug Advisory Committee (ODAC) will review their very promising investigational drug Satraplatin for the Treatment of Hormone Refractory Prostate Cancer. The hearing will be held on July 24, 2007. This is very exciting, especially in light of the FDA’s surprising failure to approve Provenge. A quick review of [...]