Spectrum, GPC Biotech begin rolling NDA for cancer drug satraplatin

By Angela McDaniels

Seattle, Dec. 15 - Spectrum Pharmaceuticals Inc. said its co-development partner, GPC Biotech AG, has begun the rolling submission of a New Drug Application with the Food and Drug Administration for satraplatin in combination with prednisone as a second-line chemotherapy treatment for patients with hormone-refractory prostate cancer.

To begin the rolling application process, the company has filed the chemistry, manufacturing and controls section of the New Drug Application.

The rolling submission process enables companies that have been granted fast track designation by the FDA to submit sections of the application to the agency as they become available, allowing the review process to begin before the complete dossier has been submitted.

Under U.S. regulations, the FDA will determine whether that application may be filed within 60 days after the receipt of such a submission. The filing of an application means that the FDA has determined that the application is sufficiently complete to permit a substantive review.

The FDA's fast track programs are intended to expedite the review of drugs that treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. The FDA granted fast track designation to satraplatin as a second-line chemotherapy treatment for patients with hormone-refractory prostate cancer in September 2003, the company said.

"The submission of the rolling NDA is major step forward toward the ultimate goal of making satraplatin available to patients as quickly as possible," chairman, chief executive officer and president Rajesh C. Shrotriya said in a company press release.

"In December alone, we achieved our target enrollment in the phase 3 registrational trial, announced the opening of accrual of a phase 2 study evaluating satraplatin in combination with Taxol (paclitaxel) and reported that the independent Data Monitoring Board reviewed the safety data from the phase 3 trial and recommended that the trial continue as planned."

Satraplatin is a member of the platinum family of compounds. Unlike platinum drugs currently on the market, all of which require intravenous administration, satraplatin is an orally bioavailable compound and is given as capsules that patients can take at home.

Worldwide sales of platinum drugs exceeded $2.2 billion in 2004, the company said.

GPC Biotech has completed a Special Protocol Assessment with the FDA and has received a Scientific Advice letter from the European Medicines Agency, Spectrum said.

GPC Biotech AG is a biopharmaceutical company based in Martinsried/Munich, Germany, that develops new anti-cancer drugs.

Spectrum is a pharmaceutical company based in Irvine, Calif., that acquires, develops and commercializes prescription drug products for the treatment of cancer and other unmet medical needs.

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