FDA panel backs approval of Roche drug in early breast cancer

Roche Holding AG’s drug Perjeta, currently approved to treat metastatic breast cancer, should also be approved to help shrink tumors prior to surgery, an advisory panel to the U.S. Food and Drug Administration said on Thursday.

The panel voted 13 to 0, with one abstention, that the drug’s benefits outweighed its risk, even though the trial was small with 107 patients taking Perjeta in combination with Roche’s drug Herceptin and chemotherapy and 107 taking Herceptin plus chemotherapy alone.

Perjeta would be the first drug to be approved to shrink tumors prior to additional breast cancer treatment in the United States. Dr. Mikkael Sekeres of the Cleveland Clinic and chairman of the advisory committee described the vote as “historic.”

The panel concluded that the totality of the evidence about Perjeta, including its relative safety as a treatment for advanced breast cancer, tilted their decision in favor of approval despite the small trial size.

Roche is seeking approval to market Perjeta, also known as pertuzumab, for patients whose tumors contain excess levels of the HER-2 protein. As required by the FDA, the company is also conducting a follow-up trial in 4,800 patients who have already had surgery.

Panelists urged the FDA to carefully scrutinize the results of the follow-up trial to ensure they support the benefit to patients suggested by the small trial.

The Perjeta regimen would be given as part of a broad treatment program that would include the chemotherapies docetaxel and either fluorouracil, epirubicin, and cyclophosphamide or carboplatin.

The FDA has expressed some concern that Perjeta, in combination with anthracycline chemotherapies such as epirubicin, could cause heart problems. Roche said it intends to address the questions with an additional trial of Perjeta in combination with a variety of chemotherapy regimes, including anthracyclines.

The FDA is not required to follow its panel’s advice but typically does so.

(Reporting by Toni Clarke in Washington; Editing by Maureen Bavdek and Jim Marshall)

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(Reuters)