Roche Holding AG RHHBY announced that it has completed the submission of a supplemental Biologics License Application (sBLA) to the FDA to expand the label of its breast cancer drug Kadcyla. The company is seeking FDA approval for Kadcyla for adjuvant (after surgery) treatment of patients with HER2-positive early breast cancer (eBC) with residual disease after neoadjuvant (before surgery) treatment. 

Kadcyla, an antibody-drug conjugate, is approved as monotherapy in second-line setting for treating metastatic breast cancer

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