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Roche: FDA approves Perjeta for early breast cancer

(CercleFinance.com) - US drug regulators have given the go-ahead for Roche's Perjeta in the treatment of a specific type of early breast cancer, the Swiss drugmaker said on Thursday.

The Food and Drug Administration (FDA) has approved Perjeta, in combination with Herceptin and chemotherapy, for treatment after surgery of HER2-positive early breast cancer (eBC) with a high risk of recurrence.

According to a study, a combination of the three drugs significantly reduced the risk of invasive breast cancer recurrence or death by 18% compared to Herceptin and chemotherapy alone, Roche said.

Roche also said this Thursday that the European Commission has granted a marketing authorisation for Alecensa as a monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive, advanced non-small cell lung cancer (NSCLC).

The approval is based on results from a phase III study, which showed Alecensa significantly reduced the risk of disease worsening or death by 53%.

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