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sBLA for Full Approval of Blinatumomab in ALL Granted FDA's Priority Review
March 30th 2017The FDA has granted a priority review to a supplemental biologics license application (sBLA) supporting the conversion of the accelerated approval of blinatumomab (Blincyto) to a full approval as a treatment for patients with Philadelphia chromosome-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL).
Active Surveillance May Provide QoL Benefits for Low-Risk Prostate Cancer
March 29th 2017Daniel A. Barocas, MD, discusses a study that compared differences in quality of life among patients who have undergone radical prostatectomy, external beam radiotherapy, brachytherapy or active surveillance for low-risk prostate cancer.
Next Few Years Will Bring Immunotherapy to the Forefront of Therapy for Urothelial Carcinoma
March 28th 2017Evan Y. Yu, MD, discusses the current treatment options for metastatic urothelial carcinoma, the unmet needs that still exist in this space, and the possibilities for the future treatment landscape.
Niraparib Approved by FDA for Ovarian Cancer
March 27th 2017The PARP inhibitor niraparib (Zejula) has been approved by the FDA for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.
New Screening Approach Is a Step Toward an Effective Way to Delay Oophorectomy, Expert Says
March 27th 2017Steven J. Skates, PhD, discusses a study on early detection of ovarian cancer using the Risk of Ovarian Cancer Algorithm (ROCA), in which CA125 was tested in women with high risk who chose to postpone surgery.
EMA Recommends Nivolumab for Approval in Head and Neck Cancer
March 24th 2017Nivolumab (Opdivo) has been recommended for approval by EMA’s Committee for Medicinal Products for Human Use for the treatment of patients with squamous cell cancer of the head and neck following progression on platinum-based therapy.
PD-1 and IDO Inhibitor Combo Could Change Standard of Care in Melanoma
March 24th 2017The first-in-class IDO1 inhibitor epacadostat (INCB024360), currently being investigated in combination with the PD-1 inhibitor pembrolizumab (Keytruda), could be an exciting new FDA approval for patients with stage III/IV unresectable or metastatic melanoma.