FDA granted a fourth Breakthrough Therapy Designation to Imbruvica (ibrutinib) as a potential treatment of chronic graft-versus-host-disease after failure of one or more lines of systemic therapy. The agency also granted the therapy Orphan Drug Designation for the condition. The request was based on preliminary clinical data from a phase Ib/II study evaluating the safety […]
FDA approved the cobas EGFR Mutation Test v2, a blood-based companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved, blood-based genetic test that can detect epidermal growth factor receptor gene mutations in non-small cell lung cancer patients.
Genomic Health Inc. launched Oncotype SEQ Liquid Select, the first of several non-invasive liquid biopsy tests that the company plans to deliver through its Oncotype IQ Genomic Intelligence Platform. Oncotype SEQ is a blood-based test that identifies and assesses actionable genomic alterations in a panel of 17 select genes to inform the treatment of stage... […]
The Canadian Agency for Drugs and Technologies in Health made a positive recommendation for Opdivo (nivolumab) for the treatment of non-small cell lung cancer. The CADTH evaluation of Opdivo was made under the pan-Canadian Oncology Drug Review process.
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... […]
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... […]
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... […]
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... […]
FDA approved the cobas EGFR Mutation Test v2, a blood-based companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved, blood-based genetic test that can detect epidermal growth factor receptor gene mutations in non-small cell lung cancer patients.
Mylan N.V. announced the U.S. launch of Azacitidine for Injection, 100 mg/vial, a generic version of Celgene’s Vidaza Injection. Mylan received final approval from FDA for its Abbreviated New Drug Application for this product. Azacitidine for Injection is a nucleoside metabolic inhibitor indicated for the treatment of the five French-American-British subtypes of myelodysplastic syndrome. jQuery(document).ready(function(){... […]
