Paid

Vose: “Are We Ready To Care For These Patients? 

Julie Vose, outgoing president of the American Society of Clinical Oncology, addressed the opening session of the society's annual meeting in Chicago, discussing the themes of her year in office, the coming changes in federal cancer research and Medicare reimbursement, and the progress made over the society's past 52 years.
Drugs & Targets

FDA grants orphan designations to Debio 1143 and SUBA-Itraconazole Capsules

FDA granted Orphan Drug Designation to Debio 1143 for the treatment of ovarian cancer. Debio 1143 is an oral, small molecule inhibitor with a dual pro-apoptotic and immunomodulatory mode of action developed as a chemo/radio-sensitizer, according to Debiopharm International SA, the drug’s sponsor. Debiopharm plans to expand the clinical development of this therapy to patients... […]
Drugs & Targets

FDA grants Priority Review of telotristat etiprate in carcinoid syndrome

FDA granted Priority Review to oral telotristat etiprate for the treatment of carcinoid syndrome. The agency has set a target action date of Nov. 30. Telotristat etiprateis sponsored by Lexicon Pharmaceuticals Inc. Telotristat etiprate targets tryptophan hydroxylase, an enzyme that triggers the excess serotonin production within mNET cells that leads to carcinoid syndrome. Telotristat etiprate... […]
Drugs & Targets

European Commission approves Afinitor, Imbruvica

The European Commission approved Imbruvica (ibrutinib) as a first-line treatment option for adult patients with chronic lymphocytic leukemia, expanding upon the initial approval in October 2014 for certain patients with CLL. This decision comes one month after the Committee for Medicinal Products for Human Use issued an opinion in favor of the use of Imbruvica... […]
Drugs & Targets

FDA approves NETSPOT for neuroendocrine tumors

FDA approved NETSPOT (Somakit-TATE) for the localization of somatostatin receptor positive neuroendocrine tumors in adult and pediatric patients. NETSPOT received approval following a Priority Review, and is currently approved for use with the GalliaPharm Ga 68 generator from Eckert & Ziegler. NETSPOT is the first approved drug using Ga 68 as a positron emitter. Gallium... […]
In Brief

ACCC launches Metastatic Breast Cancer Project

THE ASSOCIATION OF COMMUNITY CANCER CENTERS launched the Metastatic Breast Cancer Project to address communications challenges faced by patients. ACCC is partnering with the Avon Breast Cancer Crusade, the Cancer Support Community, and the Metastatic Breast Cancer Alliance on this education initiative, with funding and support from Pfizer Oncology. “The public has a limited knowledge... […]
In Brief

FDA publishes two guidances on compassionate use

FDA finalized efforts to streamline the process used by physicians to request expanded access, often called compassionate use, to investigational drugs and biologics, as well as two guidance documents. “As a physician, I understand the importance of being able to access investigational treatments for a patient when there are no other options to treat their... […]