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(){... […]
FDA granted accelerated approval to Tecentriq (atezolizumab) for urothelial carcinoma, the most common type of bladder cancer. This is the first product in its class of PD-1/PD-L1 inhibitors approved to treat this type of cancer, according to the drug's sponsor, Genentech.
ProNAi Therapeutics, Inc. obtained an exclusive license from Carna Biosciences Inc. in Japan for worldwide rights to develop and commercialize AS-141, a small molecule kinase inhibitor targeting CDC7. Under the terms of the agreement, ProNAi will pay Carna Biosciences an initial upfront payment of $0.9 million and aggregate additional potential payments upon achievement of certain... […]
The European Medicines Agency Committee for Medicinal Products for Human Use adopted a positive opinion to extend the indication for Kyprolis (carfilzomib) to include treatment in combination with dexamethasone alone for adult patients with multiple myeloma who have received at least one prior therapy.
FDA granted accelerated approval to Tecentriq (atezolizumab) for urothelial carcinoma, the most common type of bladder cancer. This is the first product in its class of PD-1/PD-L1 inhibitors approved to treat this type of cancer, according to the drug's sponsor, Genentech.
The FDA Division of Drug Information is informing health care professionals that a counterfeit version of BiCNU (carmustine for injection) 100 mg, has been detected in some foreign countries. There is no indication at this time that counterfeit BiCNU has entered the legitimate U.S. drug supply chain and no indication that any U.S. patients have... […]
Health Canada granted approval for Imbruvica (ibrutinib), as an oral, once-daily, single-agent therapy for the treatment of patients with Waldenström’s macroglobulinemia. This approval was based on an investigator-led, multicenter, prospective, single-arm study in 63 patients who had received at least one prior therapy. The results of the study were published in the New England Journal... […]
