CAMBRIDGE, Mass. Aura Biosciences, a biotech company developing highly tumor-targeted breakthrough therapies for rare cancers, has been granted Orphan Disease Designation by the FDA for its drug AU-011 for the treatment of Uveal Melanoma. The FDA’s Orphan Drug Designation program provides orphan status to drugs and biologics, which demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions in the US. In addition, the first oral presentation of Aura Biosciences’ pre-clinical research, ‘Evaluating the in vivo efficacy of a first-in-class drug for the treatment of primary uveal melanoma’, was recently delivered by McGill University Health Centre researchers at the ARVO (Association for Research in Vision and Ophthalmology) Annual Meeting.
Regulatory
Experts Endorse Amgen’s Immunotherapy for Advanced Melanoma
Progress toward immunotherapy treatments for melanoma advanced another step with near-unanimous support from FDA advisors for Amgen Inc’s talimogene laherparepvec (T-VEC). An oncolytic virus immunotherapy, T-VEC has been developed for patients with injectable regionally or distantly metastatic melanoma. If approved, it will be the first product in a new class of drugs, oncolytic immunotherapies.
FDA Grants Priority Review to Frontline Nivolumab in Melanoma
The FDA has assigned a priority review designation to the PD-1 inhibitor nivolumab (Opdivo) as a treatment for previously untreated patients with unresectable or metastatic melanoma. Under the expedited process, the action date for the FDA’s decision is August 27, 2015.
FDA panel backs Amgen’s T-Vec for melanoma
An FDA advisory committee has voted in favour of approving Amgen’s virus-like melanoma therapy, despite questions about its impact on survival.