FDA approvals December 20, 2017

• FDA granted regular approval to pertuzumab (PERJETA, Genentech, Inc.) for use in combination with trastuzumab and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. More Information.  December 20, 2017
• FDA granted regular approval to the anti-PD1 monoclonal antibody, nivolumab (OPDIVO, Bristol-Myers Squibb Company) for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or in patients with metastatic disease who have undergone complete resection. Nivolumab was previously approved for the treatment of patients with unresectable or metastatic melanoma. More Information.  December 20, 2017

Other Hematology/Oncology (Cancer) Approvals & Safety Notifications