Roche to Seek Regulatory Approval for Breast Cancer Treatment by Year End

Roche Holding AG (ROG) will seek regulatory approval this year for a breast cancer treatment that the company said extended patients’ lives without their disease getting worse in a clinical trial.

The treatment, pertuzumab, when combined with chemotherapy and Roche’s Herceptin, helped patients with an aggressive form of breast cancer more than chemotherapy and Herceptin alone, Roche said today in a statement, citing the results of a late- stage clinical trial called Cleopatra.

Pertuzumab, like Herceptin, works by neutralizing the so- called HER-2 protein linked to tumor growth. Both drugs were developed by U.S. biotechnology company Genentech Inc., which Basel, Switzerland-based Roche fully acquired in 2009 for $46.8 billion. Roche is the world’s biggest maker of cancer medicines.

“These results with pertuzumab combined with Herceptin and docetaxel are very encouraging,” Hal Barron, Roche’s head of global product development, said in the statement, referring to the type of chemotherapy used in the study. “We plan to submit the study results for global regulatory approval this year.”

Roche may need more information on overall patient survival to win U.S. regulatory approval, Jack Scannell, an analyst at Sanford C. Bernstein in London, said.

“The Food and Drug Administration wonders if a therapy is worth approving if all it can claim is that it slows the rate at which CT and MRI scans get worse,” Scannell wrote today in a note to clients. “The size of pertuzumab’s incremental benefit may also come under scrutiny given the likely cost.”

Roche rose 90 centimes, or 0.7 percent, to 136.8 francs at 11:27 a.m. in Zurich.

To contact the reporter on this story: Charles Mead in London at cmead11@bloomberg.net.

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net

Press spacebar to pause and continue. Press esc to stop.

Bloomberg reserves the right to remove comments but is under no obligation to do so, or to explain individual moderation decisions.

Please enable JavaScript to view the comments powered by Disqus.