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... […]
FDA approved an expansion to the Imbruvica (ibrutinib) prescribing information based on data supporting its use in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma.
Health Canada provided conditional approval of Ibrance (palbociclib) for the treatment of postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer as initial endocrine-based therapy for metastatic disease. The Health Canada approval of Ibrance is based on the final results of the phase II PALOMA-1/TRIO 18 trial (n=165), which studied... […]
The European Commission approved a variation to the terms of the Marketing Authorisation of eribulin for the treatment of adult patients with unresectable liposarcomas who have received prior anthracycline containing therapy for advanced or metastatic disease.
AbbVie and CytomX Therapeutics Inc. entered into a collaboration to co-develop Probody Drug Conjugates against CD71, also known as transferrin receptor 1 (TfR1). Probody therapeutics are designed to take advantage of conditions in the tumor microenvironment to enhance the tumor-targeting features of an antibody and reduce drug activity in healthy tissues. Under the agreement, CytomX... […]
