FDA rewards Roche with priority review for blockbuster cancer drug

Posted under Blog, breast cancer, Companies, Diagnostics, Funding, Genentech, Herceptin, Medical Devices, Medical Supply, pertuzumab, Pharmaceuticals, Roche, Startups, Universities, Videos by John Carroll

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 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

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Roche, Novartis showcase game-changing breast cancer drug data

Posted under Afinitor, Blog, breast cancer, Companies, Diagnostics, Funding, Herceptin, Medical Devices, Medical Supply, Novartis, pertuzumab, Pharmaceuticals, Roche, Startups, Universities, Videos by John Carroll

Roche and Novartis ($NVS) put out new data yesterday on two treatments that promise to fundamentally reshape the way the majority of breast cancer patients are treated. Roche clearly impressed specialists and analysts with the news that pertuzumab combined with Herceptin and chemotherapy checked tumor development for a median of slightly more than six months--from 8.5 months to 12.4 months. And Novartis's Afinitor demonstrated a four-month delay in disease progression among metastatic patients.

"These are two new therapies, targeted therapies, that will change the standard of care for women with metastatic disease," Jose Baselga, chief of oncology at Massachusetts General Hospital and a lead author for both studies, tells Bloomberg. "They are elegant, they are hypothesis-driven and they are working through well-known mechanisms."

Afinitor is already approved for other cancers, following Novartis's game plan for mapping a path to a steadily growing marketplace. But it was the experimental pertuzumab that had gripped the attention of the field in the lead-up to the big San Antonio Breast Cancer Symposium. The treatment offers a second pathway to managing HER2-positive breast cancer, which is present in about one in four cases. By offering a much-improved combination therapy for breast cancer, Roche puts itself on the road to an approval that could gain an additional $2 billion a year in revenue while guarding itself against any new biosimilars of Herceptin.

"These are among the most significant findings in drugs for metastatic cancer in the past five years," Dana-Farber's Eric Winer tells The Wall Street Journal. But Roche and Novartis still have a ways to go before they complete their case on breast cancer. The gold standard for cancer data is an overall survival rate, and investigators are still piecing that picture together. Roche has already filed for an approval of pertuzumab in Europe and Genentech filed its BLA in the U.S.

- get the release from Roche
- here's more from The Wall Street Journal
- read the article from Bloomberg
- see the story from Reuters

Special Report: Pertuzumab - 15 top blockbuster contenders

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Roche preps full data on blockbuster hopeful for breast cancer

Posted under Blog, breast cancer, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, pertuzumab, Pharmaceuticals, Roche, Startups, Universities, Videos by Ryan McBride

After the FDA dropped its breast cancer label on Avastin this month, Swiss pharma giant Roche could regain some steam in early December when it presents full data on its late-stage experimental breast cancer drug pertuzumab. There's a lot riding on the success of the drug, which analysts have estimated could bring in about $2 billion in annual revenue if approved.

At the annual CTRC-AACR San Antonio Breast Cancer Symposium (SABCS), which starts Dec. 6, the company will highlight full data on its Phase III pivotal trial that compared a treatment combo of pertuzumab, Herceptin and chemo to chemo and Herceptin alone in patients with aggressive forms of HER2-positive breast cancer. While the company has already said pertuzumab showed that it helped patients live longer without their cancer getting worse, the devil will be in the details, as the market success of the drug could depend on just how much of an improvement the drug offers.

Roche is looking to pertuzumab to build on its lead in treating HER2-positive breast cancers, for which it now markets Herceptin. Like Herceptin, pertuzumab also binds to the HER2 protein, but the experimental drug targets different regions of the protein than Herceptin, bolstering Roche's argument that the two drugs used together complement each other. Pertuzumab could also help support Roche's breast cancer drug franchise once Herceptin runs into competition from copycat drugs.

"The market is materially undervaluing pertuzumab in HER2 breast cancer, which will help negate the potential negative impact of Herceptin biosimilars," said Citigroup analyst Andrew Baum, as quoted by Dow Jones Newswires.

Stefan Frings, head of medical affairs oncology at Roche, reaffirmed in an interview with Dow Jones that the company plans to file for approvals of pertuzumab by the end of this year.

- here's the release
- see Dow Jones' coverage

Special Report: Pertuzumab - 15 top blockbuster contenders

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