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Expert Says Olaparib Label Needs Expansion
May 5th 2015The FDA’s recent approval of olaparib for women with BRCA-mutated advanced ovarian cancer marks a significant therapeutic advance for women with the malignancy, but the specific indication is far too restrictive and the drug should be offered to many more patients.
Frontline Nivolumab Granted FDA Priority Review in Melanoma
April 30th 2015The PD-1 inhibitor nivolumab (Opdivo) has been has been assigned priority review designation from the US Food and Drug Administration (FDA) as a treatment for previously untreated patients with unresectable or metastatic melanoma.
T-VEC for Melanoma Receives FDA Panel Support
April 30th 2015Members of the FDA’s Oncologic Drugs Advisory Committee (ODAC) and Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) voted 22-1 in a combined decision to recommend approval of the oncolytic immunotherapy talimogene laherparepvec (T-VEC) as a treatment for patients with advanced melanoma.
Combining Ofatumumab With Chemotherapy Delays Progression in CLL
April 29th 2015Topline findings from the phase III COMPLEMENT 2 study indicated that treatment with ofatumumab (Arzerra) plus fludarabine and cyclophosphamide significantly improved progression-free survival (PFS) compared with fludarabine and cyclophosphamide alone in patients with relapsed chronic lymphocytic leukemia (CLL).
Liquid Biopsies Detect Minimal Residual Disease in Colorectal Cancer
April 29th 2015Two different types of liquid biopsies—plasma and urine—can detect the number of copies of the KRAS mutation in circulating DNA in patients with colorectal cancer who have resectable liver metastases with near 100% concordance with tissue biopsies, according to a pilot study presented at the 2015 Annual Meeting of the American Association for Cancer Research (AACR).
NDA Submitted for MM-398 With 5-FU and Leucovorin in Advanced Pancreatic Cancer
April 28th 2015Following the FDA fast track designation in November 2014, Merrimack Pharmaceuticals and Baxter International have completed the submission of a new drug application for MM-398 in combination with 5-fluorouracil and leucovorin, according to a statement from the drug's developers.
New Collaboration Forms for Immunotherapy Regimens in Hematologic Malignancies
April 27th 2015MedImmune Limited, a subsidiary of AstraZeneca PLC, and Celgene International II Sà rl, a subsidiary of Celgene Corporation, have formed a strategic collaboration for the development and commercialization of AstraZeneca’s anti-programmed cell death-ligand 1 (PD-L1) agent MEDI4736.
Tumor-Only Gene Sequencing May Expose Half of Cancer Patients to Unsuitable Treatments
April 15th 2015Almost half of patients with cancer who receive genetic testing may be given information that leads to unsuitable targeted treatments, according to researchers from Johns Hopkins Kimmel Cancer Center.
'Using Common Sense' in Prostate Cancer Screening Debate
April 14th 2015The continuing contentious debate about screening for prostate cancer remains top of mind among the public and lay press, but, Leonard G. Gomella, MD, says the decision to screen or not to screen boils down to “using common sense.â€
Whole-Genome Sequencing Identifies New Targets in Pancreatic Cancer
April 14th 2015A research team led by investigators at the University of Texas Southwestern Medical Center in Dallas has published a study in Nature Communications identifying several new genetic mutations in pancreatic ductal adenocarcinoma.
ADT May Impact Physical Function, Highlighting Need for Exercise
April 2nd 2015Shabbir M.H. Alibhai, MD, et al from the University Health Network in Toronto, Canada, found that impact from ADT on physical function persisted over 36 months, indicating ADT has lasting effects, which need to be addressed.
Survival Advantage Seen With IP Chemotherapy for Ovarian Cancer
April 2nd 2015Intraperitoneal (IP) chemotherapy offers a median 10-month survival advantage over IV chemotherapy for women with advanced ovarian cancer. Result from a retrospective analysis were recently published in the Journal of Clinical Oncology.