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Oncology

Ignyta’s Lung Cancer Drug Receives Orphan Drug Status from the FDA

Today, precision oncology biotechnology company Ignyta, Inc. announced that its lead candidate has been granted orphan drug designation from US health regulators. According to the company, the US Food and Drug Administration (FDA) granted Ignyta’s entrectinib orphan drug designation for the treatment of TrkA-positive, TrkB-positive, TrkC-positive, ROS1-positive and ALK-positive non-small …

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Roche’s Gazyva Succeeds in its Late-Stage Trial in Non-Hodgkin’s Lymphoma

Roche announced that it has ended its late-stage study evaluating its leukemia drug Gazyva earlier than expected following positive results. The company announced positive results from the Phase III GADOLIN study, which evaluated treatment options for patients with indolent non-Hodgkin’s lymphoma (NHL) who are refractory to MabThera/Rituxan (rituximab) treatment. After …

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Pfizer’s Breast Cancer Drug Receives Accelerated Approval from the FDA

Federal health regulators have provided an early approval to Pfizer Inc.’s Breakthrough breast cancer drug palbociclib. The company announced that the US Food and Drug Administration (FDA) has granted accelerated approval of Ibrance (palbociclib) in combination with letrozole, for the treatment of postmenopausal women with estrogen receptor-positive, human epidermal growth …

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Committee Recommends Continuation of CTI BioPharma’s Ovarian Cancer Study

Today, CTI Biopharma Corp. announced that an independent committee has recommended that the company continue its ovarian cancer study. The company said that the Gynecologic Oncology Group, now part of NRG Oncology, informed CTI that an independent Data Monitoring Committee (DMC) recommended continuation of the Phase III GOG-0212 clinical study, …

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Genentech’s Investigational Monoclonal Antibody Granted Breakthrough Status for Treatment of Lung Cancer

US-based Genentech recently announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for its investigational cancer immunotherapy. The agency granted the designation to Genentech’s MPDL3280A for treatment of patients with Programmed Death-Ligand 1 (PD-L1) positive non-small cell lung cancer (NSCLC) whose disease has progressed during …

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Amgen Submits Applications for Approval of its Multiple Myeloma Drug Kyprolis in the US and Europe

Amgen and its subsidiary Onyx Pharmaceuticals, Inc. recently announced that it has submitted applications to both US and EU health regulators for approval of Kyprolis (carfilzomib) for treatment of multiple myeloma. The companies said that they have submitted a supplemental New Drug Application (sNDA) to the US Food and Drug …

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Insys’ Ovarian Cancer Treatment Receives Orphan Drug Designation from the FDA

The US Food and Drug Administration (FDA) granted Orphan Drug designation for Insys Therapeutics’ ovarian cancer candidate. The agency granted the designation to Insys’ Liposomal Encapsulated Paclitaxel (LEP) candidate for the treatment of ovarian cancer. The FDA’s Office of Orphan Products Development grants novel drugs or biologics that treat rare …

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