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FDA Approvals, News & Updates

Imfinzi the Second Immunotherapy Approved for Advanced Bladder Cancer

Bavencio First Immunotherapy Drug Approved for Merkel-Cell Carcinoma

Kisqali a New First-Line Treatment for Patients with Advanced Breast Cancer
In March 2017, the FDA approved Kisqali (ribociclib), in combination with an aromatase inhibitor, for the first-line treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer. Read More ›

Keytruda Now Available for Patients with Relapsed Classical Hodgkin Lymphoma
In March 2017, the FDA approved Keytruda (pembrolizumab), anti-PD-1 immunotherapy, for the treatment of patients with classical Hodgkin lymphoma who are not responding to other therapy or whose disease (relapsed) returned after 3 or more therapies. Keytruda was previously approved for several cancers. Read More ›

Revlimid Approved for Maintenance Therapy in Patients with Multiple Myeloma After Transplant
In February 2017, the FDA approved the oral drug Revlimid (lenalidomide) for maintenance (continuing) therapy for patients with multiple myeloma who had autologous hematopoietic stem-cell transplant. Revlimid was previously approved for multiple myeloma and for other types of cancer. Read More ›

Imbruvica First Non-Chemotherapy Drug Approved for Patients with Marginal Zone Lymphoma
In January 2017, the FDA approved Imbruvica (ibrutinib) for the treatment of patients with marginal zone lymphoma who need systemic therapy and have received at least 1 previous anti-CD20-based therapy. Read More ›

Opdivo a New Treatment Option for Patients with Advanced or Metastatic Bladder Cancer
In February 2017, the FDA approved Opdivo (nivolumab), anti-PD-1 immunotherapy, for the treatment of patients with locally advanced or metastatic bladder cancer (urothelial carcinoma) whose disease progressed during or after platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Read More ›

Rubraca a New Oral Treatment Approved for Patients with Advanced Ovarian Cancer
In December 2016, the FDA approved Rubraca (rucaparib), a new oral PARP inhibitor, for the treatment of advanced ovarian cancer with a BRCA mutation (alteration) in patients who had received at least 2 chemotherapies. Read More ›

Xermelo First Oral Treatment for Carcinoid Syndrome Diarrhea in Patients with Metastatic NETs
In February 2017, the FDA approved the oral drug Xermelo (telotristat ethyl) for the treatment of carcinoid syndrome diarrhea, in combination with a somatostatin analog (SSA), in adults with metastatic neuroendocrine tumors (NETs) whose condition is inadequately controlled by SSA therapy. Xermelo is the first oral therapy available for patients with carcinoid syndrome diarrhea in patients with NETs. Read More ›

What's New in Multiple Myeloma Therapy?
In the first 3 months of 2015, new developments in myeloma drugs could have important implications for the survival and quality of life of patients with multiple myeloma. Read More ›

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