FDA granted regular approval to Keytruda (pembrolizumab) for patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
The Committee for Medicinal Products for Human Use of the European Medicines Agency recommended approval of expanding the use of Zykadia (ceritinib) to include the first-line treatment of patients with advanced non-small cell lung cancer whose tumors are anaplastic lymphoma kinase-positive.
FDA has approved Keytruda (pembrolizumab), an anti-PD-1 therapy, in combination with pemetrexed (brand name Alimta) and carboplatin (pem/carbo), a commonly used chemotherapy regimen, for the first-line treatment of metastatic nonsquamous NSCLC, irrespective of PD-L1 expression.
FDA granted accelerated approval to avelumab (trade name Bavencio) for patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
FDA has approved the Kisqali Femara Co-Pack (ribociclib tablets; letrozole tablets) for the treatment of hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in postmenopausal women.
The European Commission has approved the antibody ch14.18/CHO, dinutuximab beta, for the treatment of high-risk neuroblastoma in patients aged 12 months and above.
FDA granted Fast Track designation for Reolysin, an immuno-oncology viral agent, for the treatment of metastatic breast cancer.
The European Medicines Agency granted orphan drug designation to PIQUR's lead compound PQR309 for the treatment of patients with diffuse large B-cell lymphoma.
The Addario Lung Cancer Medical Institute and Biocept Inc. announced a clinical collaboration and initiation of the landmark ALCMI-009 liquid biopsy clinical trial, which was developed and will be conducted by ALCMI and its consortium of leading U.S. and international oncology centers.
EpiThany, Merck KGaA, Pfizer to evaluate combination of avelumab and EP-101 STEMVAC in breast cancer
EpiThany today announced that they have entered into a collaboration agreement with Merck KGaA, Darmstadt, Germany, and Pfizer to evaluate avelumab*, a human anti-PD-L1 antibody, and EP-101 STEMVAC, a multi-antigen, polyepitope vaccine, in a phase II trial in women with breast cancer.
