FDA Approves Nerlynx-Xeloda Combo For HER2-Positive Breast Cancer

Home Blog FDA Approves Nerlynx-Xeloda Combo For HER2-Positive Breast Cancer

The Food and Drug Administration (FDA) has approved a supplemental new drug application for Nerlynx (neratinib) in combination with Xeloda (capecitabine) for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have previously received two or more anti-HER2 based therapies in the metastatic setting. 

According to Cure Today, the approval comes off the heels of the phase 3 NALA trial that looked at the efficacy of Nerlynx in combination with Xeloda, which found a significant improvement in patient’s progression free survival (the time from treatment to disease progression or worsening) compared to Tykerb (lapatinib) in combination with Xeloda. The progression free survival rate at 12 months for patients receiving Nerlynx and Xeloda was 29% compared to 15% for those receiving Tykerb and Xeloda. 

Click here to read the full article from Cure Today

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