publication date: Mar. 6, 2015

FDA Grants Breakthrough Therapy Designation to EBV-CTL

 

FDA granted Breakthrough Therapy Designation to EBV-CTL for the treatment of Epstein-Barr Virus following transplant of bone marrow stem cells.

EBV-CTLs are donor-derived, not genetically modified, cancer fighting T-cells. EBV-CTLs are designed to provide immunocompromised patients with T-cells that recognize, target and destroy EBV-infected lymphoma cells.

The program is sponsored by Atara Biotherapeutics Inc. In September 2014, Atara entered into an exclusive option agreement with Memorial Sloan Kettering Cancer Center to acquire the exclusive, worldwide license rights to three clinical product candidates focusing on targets involved in cancers and serious infections.

 

The Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion to extend the marketing authorization for Vectibix (panitumumab) to include combination with FOLFIRI as first-line treatment in adult patients with wild-type RAS metastatic colorectal cancer.

The new indication is based upon the 20060314 study, which evaluated Vectibix plus FOLFIRI in the first-line setting. Vectibix is already approved in the European Union for the treatment of adult patients with wild-type RAS mCRC.

The CHMP positive opinion will now be ratified by the European Commission who, should they affirm the CHMP opinion, will extend the centralized marketing authorization which is valid in the 28 countries that are members of the EU, as well as European Economic Area members, Iceland, Lichtenstein and Norway. Vectibix is sponsored by Amgen.

 

FDA launched a mobile application designed to speed public access to information about drug shortages. The app identifies current drug shortages, resolved shortages and discontinuations of drug products.

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