In a combined decision, members of the FDA’s Oncologic Drugs Advisory Committee (ODAC) and Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) voted 22-1 to recommend approval of the oncolytic immunotherapy talimogene laherparepvec (T-VEC) as a treatment for patients with advanced melanoma. A final approval decision from the FDA is scheduled by October 27, 2015.
Regulatory
FDA grants orphan drug designation to SolaranRx’s SRX-1177 for malignant melanoma treatment
SolaranRx announced it has received orphan drug designation from the FDA for SRX-1177, its product for treating stage IIB to IV malignant melanoma.
FDA grants orphan drug designation to Samcyprone for malignant stage IIb to IV melanoma
RXi Pharmaceuticals announced it has received orphan drug designation from the FDA for Samcyprone, its clinical candidate for treating malignant melanoma stage IIb to IV.
FDA Grants AstraZeneca’s Selumetinib Orphan Drug Status for Treatment of Uveal Melanoma –Update
AstraZeneca PLC’s (AZN.LN) selumetinib drug has been granted a special status by the U.S. Food and Drug Administration for treatment of Uveal melanoma, a rare eye disease.