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Hochster Joins Rutgers Cancer Institute of New Jersey and RWJBarnabas Health
January 12th 2018Howard S. Hochster, MD, an internationally recognized leader in the development of cancer clinical trials, gastrointestinal oncology, and early phase cancer drugs, has joined Rutgers Cancer Institute of New Jersey as associate director for clinical research and chief of gastrointestinal medical oncology.
Expert Discusses Impressive Findings With Sacituzumab Govitecan in Metastatic TNBC
January 11th 2018Aditya Bardia, MD, MPH, discusses phase I/II trial of sacituzumab govitecan which showed favorable clinical activity in patients with relapsed or refractory metastatic triple-negative breast cancer who have received at least 2 prior treatment regimens.
Superior PFS Maintained Over Time With Daratumumab in Relapsed/Refractory Myeloma
January 11th 2018According to an updated analysis of the POLLUX trial, progression-free survival remained superior over time in patients with relapsed/refractory multiple myeloma treated with combination therapy that included the anti-CD38 antibody daratumumab.
Letrozole Maintenance Demonstrates Improved RFS in Ovarian Cancer
January 10th 2018According to a small, single-site prospective observation, women with ER-positive advanced high-grade serous ovarian cancer who received maintenance therapy with letrozole were more likely to be recurrence-free at 24 months, suggesting that letrozole may have a role to play in this setting, especially for patients with chemotherapy resistance or residual disease.<br />
Pembrolizumab Receives Approval in Japan for Urothelial Carcinoma
January 9th 2018Pembrolizumab (Keytruda) has been approved in Japan for the treatment of patients with radically unresectable urothelial carcinoma who progressed after cancer chemotherapy, according to Merck, the manufacturer of the PD-1 inhibitor.
Pembrolizumab/Lenvatinib Combo Granted FDA's Breakthrough Therapy Designation for RCC
January 9th 2018Based on results of the Ib/II Study 111, the combination of the PD-1 inhibitor pembrolizumab and the VEGF/FGF inhibitor lenvatinib has been granted a breakthrough therapy designation by the FDA for the treatment of patients with advanced and/or metastatic renal cell carcinoma.
Denosumab Granted FDA Approval for Multiple Myeloma
January 5th 2018Based on data from the phase III 482 study, denosumab (Xgeva) has been granted FDA approval for the prevention of skeletal-related events in patients with multiple myeloma, according to Amgen, the developer of the RANK ligand inhibitor.
Frontline Eltrombopag Receives FDA's Breakthrough Therapy Designation for Severe Aplastic Anemia
January 5th 2018Eltrombopag (Promacta) has been granted a breakthrough therapy designation by the FDA for use in combination with standard immunosuppressive therapy for the first-line treatment of patients with severe aplastic anemia.
The Evolving Role of Targeted Therapies in Melanoma
January 4th 2018Hussein A. Tawbi, MD, discusses the considerations he makes when choosing between immunotherapy and targeted therapy for patients with melanoma and how long-term targeted therapy data can influence treatment decisions.<br />
Expert Discusses Treatment Approaches, Research Needs for Patients With Extracutaneous Melanomas
January 4th 2018Richard D. Carvajal, MD, discusses considerations when diagnosing and treating extracutaneous melanomas and the importance of treating such diseases differently than the more commonly seen melanomas.
A Look Back at FDA News in the Month of December
January 3rd 2018The FDA closed out the year by approving several new agents last month, including bevacizumab for glioblastoma, cabozantinib for renal cell carcinoma, nivolumab for melanoma, bosutinib for chronic myeloid leukemia, and pertuzumab for HER2+ breast cancer. In addition, several agents were granted a priority review designation. Here is a look back at all the FDA activity that took place in December.
Ribociclib Granted Breakthrough Therapy Designation by FDA for HR+/HER2- Premenopausal Breast Cancer
January 3rd 2018Based on results of the phase III MONALEESA-7 trial, ribociclib (Kisqali) has been granted a breakthrough therapy designation by the FDA for use in combination with tamoxifen or an aromatase inhibitor as frontline treatment for pre- or perimenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer.
Frontline Brentuximab Vedotin Receives FDA's Priority Review for Hodgkin Lymphoma
January 3rd 2018Based on findings from the phase III ECHELON-1 trial, a supplemental biologics application (sBLA) for brentuximab vedotin (Adcetris) in combination with Adriamycin, vinblastine, and dacarbazine (AVD) has been granted a priority review by the FDA for the frontline treatment of advanced classical Hodgkin lymphoma, according to a statement from the company developing the CD30-targeted antibody-drug conjugate, Seattle Genetics.
Novel Iobenguane I-131 Agent Granted FDA's Priority Review for Rare Neuroendocrine Tumors
January 2nd 2018A new drug application for the novel version of the radiopharmaceutical iobenguane I-131 (Azedra) has been granted a priority review by the FDA for the treatment of patients with malignant or recurrent pheochromocytoma or paraganglioma, according to a statement from Progenics Pharmaceuticals, the company developing the novel iodine-131 metaiodobenzylguanidine.
Morse Gives His Perspective on Lines of Therapy for a Patient With Metastatic Colorectal Cancer
December 28th 2017Michael A. Morse, MD, explained his treatment decisions in 1 patient with metastatic colorectal cancer who progresses and requires second-line treatment during a recent <em>Targeted Oncology</em> live case-based peer perspectives dinner.
Ivosidenib Submitted for FDA Approval in IDH1+ AML
December 27th 2017Based on results of a phase I trial presented at the 2017 ASH Annual Meeting, a new drug applicaton for ivosidenib has been submitted for FDA approval for the treatment of patients with relapsed/refractory IDH1-mutant acute myeloid leukemia, according to a statement from Agios Pharmaceuticals, the company developing the targeted therapy.
Nilotinib Label for CML Updated by FDA With Discontinuation Provision
December 26th 2017The label for nilotinib (Tasigna) has been updated by the FDA with a provision stating patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP) who have received the BCR-ABL tyrosine kinase inhibitor could be eligible to stop treatment after having recieved for at least 3 years and having achieved the specific predetermined criteria.<br /> <br />
Stereotactic Radiotherapy Device Given Green Light for Early Breast Cancer by FDA
December 26th 2017Based on findings from a 17-patient study, a novel breast-specific stereotactic body radiotherapy (SBRT) device known as GammaPod has been approved by the FDA as a treatment for patients with early breast cancer.<br /> <br />
Clinical Trials Key to Expanding Novel Treatment Options in Metastatic CRC
December 22nd 2017Shubham Pant, MD, discusses therapeutic options for patients with metastatic CRC, while stressing the importance of clinical trials as an avenue to establish more novel treatment decisions in this setting.