Roche: submits breast cancer drug application to FDA

(CercleFinance.com) - Roche on Tuesday said it has filed for US marketing approval for an antibody drug that has been engineered to deliver chemotherapy directly inside breast cancer cells.


The Swiss group said it has completed the submission of a supplemental application to the Food and Drug Administration (FDA) for Kadcyla for adjuvant (after surgery) treatment of women with HER2-positive early breast cancer.

For this indication, Kadcyla was also granted "breakthrough therapy designation," which is designed to accelerate the review of drugs.

Kadcyla - which combines two anti-cancer properties - has been engineered to deliver potent chemotherapy directly to HER2-positive cancer cells, potentially limiting damage to healthy tissues, Roche said.

A phase III study has showed that the drug significantly reduced the risk of invasive breast cancer recurrence or death.

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