FDA rewards Roche with priority review for blockbuster cancer drug

After racking up a solid set of late-stage data on the experimental breast cancer drug pertuzumab late last year, Roche ($RHHBY) and Genentech scored priority review status for the program, shaving months off of the regulatory process as it drives toward a likely blockbuster approval.

Pertuzumab fits the profile for the kind of new treatments regulators are enamored with. Added to Herceptin and chemotherapy the treatment delivered a median 6.1-month halt in tumor growth among women with metastatic HER2-positive breast cancer. The pertuzumab-Herceptin combo is being credited as a better HER2 blocker, and the added benefit comes without some of the potential side effects investigators have been fretting about. Scientists in the field have called it one of the biggest medical advances in several years.

Survival data isn't scheduled to arrive until next year, but the agency's decision to extend priority review status--shaving at least four months off the regulatory process--sends a clear signal that the FDA believes the potential benefits are well worth a regulatory shortcut. In recent months regulators have been handing out approvals on targeted drugs well ahead of deadline, indicating that they are ready to reward developers which can meet the standard on targeted drugs.

Analysts at Vontobel believe that an approval can add close to $2 billion a year in added revenue for Roche.

- read the press release
- here's the Reuters article

Special Report: Pertuzumab - 15 top blockbuster contenders

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