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.
Array BioPharma Inc. announced it has entered into a clinical trial collaboration agreement with Merck (known as MSD outside the United States and Canada) to investigate the safety and efficacy of Array's MEK inhibitor, binimetinib, with Merck's anti-PD-1 therapy, Keytruda (pembrolizumab), in metastatic colorectal cancer patients with microsatellite stable tumors.
OncoSec Medical Inc. has entered a clinical trial collaboration and supply agreement with Merck to evaluate the combination of OncoSec's ImmuoPulse IL-12 with Merck's anti-PD-1 therapy Keytruda (pembrolizumab) in a phase II clinical trial, referred to as PISCES.
Regeneron Pharmaceuticals Inc. and SillaJen Inc. announced a clinical and supply agreement for a phase Ib dose-escalation study in renal cell carcinoma.