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FDA Grants Accelerated Approval to Nivolumab for Hodgkin Lymphoma
May 18th 2016The FDA has granted an accelerated approval to nivolumab for patients with classical Hodgkin lymphoma following relapse or progression after autologous hematopoietic stem cell transplantation and post-transplantation brentuximab vedotin.
CHMP Recommends Approval for Bevacizumab/Erlotinib Regimen for NSCLC
May 6th 2016The Committee for Medicinal Products for Human Use has recommended the first-line approval of bevacizumab (Avastin) in combination with erlotinib (Tarceva) for patients with advanced or metastatic EGFR-mutant non-small cell lung cancer.
FDA Grants Olaratumab Priority Review for Soft Tissue Sarcoma
May 5th 2016The FDA has granted an biologics license application for olaratumab a priority review for use in combination with doxorubicin as a treatment of patients with advanced soft tissue sarcoma who are not good candidates for radiotherapy or surgery.
Blinatumomab Granted Priority Review for Pediatric ALL
May 5th 2016The FDA has granted a priority review to a supplemental biologics license application that would extend the indication for blinatumomab to include the treatment of pediatric and adolescent patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
IP Therapy Proves Non-Superior to IV/Bevacizumab Combination in Ovarian Cancer
April 26th 2016Intraperitoneal (IP) therapy was not superior to intravenous (IV) treatment when used in combination with bevacizumab (Avastin) as a regimen for patients with advanced ovarian cancer, according to phase III findings from the GOG-252 study.
Nivolumab Granted FDA Breakthrough Designation for Head and Neck Cancer
April 25th 2016Nivolumab (Opdivo) has been granted a breakthrough therapy by the FDA as a treatment for patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) following a platinum-based therapy.
Palbociclib Boosts PFS in Phase III Breast Cancer Study
April 22nd 2016The phase III PALOMA-2 trial has shown a significant improvement in progression-free survival (PFS) for the frontline combination of palbociclib (Ibrance) and letrozole compared letrozole alone for patients with ER-positive, HER2-negative advanced or metastatic breast cancer.
Novel IDO Inhibitor Yields Durable Responses in Metastatic Pancreatic Cancer
April 21st 2016Novel therapy with indoximod, an indoleamine 2,3-dioxygenase (IDO) pathway inhibitor, in combination with standard chemotherapy, yielded a response rate of 42% as first-line therapy for metastatic pancreatic adenocarcinoma
Nivolumab Produces Robust 5-Year OS Rates in Melanoma
April 18th 2016Single-agent nivolumab (Opdivo) demonstrated a robust 5-year overall survival (OS) rate of 34% for heavily pretreated patients with metastatic melanoma who had not received prior ipilimumab (Yervoy), according to long-term findings from a single-arm phase I study.