The FDA has granted Breakthrough Therapy designation to pexidartinib (formerly PLX3397; Daiichi Sankyo/Plexxikon) for the treatment of tenosynovial giant cell tumor (TGCT) where surgical removal of the tumor would be associated with potentially worsening functional limitation or severe morbidity.
The Food and Drug Administration (FDA) has approved Yondelis (trabectedin; Janssen) for the treatment of patients with advanced soft tissue sarcoma (STS), including liposarcoma and leiomyosarcoma subtypes, who have received prior chemotherapy including an anthracycline.
The Food and Drug Administration (FDA) has accepted and granted Priority Review to the supplemental New Drug Application (sNDA) for eribulin mesylate (Eisai) for the treatment of patients with inoperable soft tissue sarcoma (leiomyosarcoma and liposarcoma) who have received prior chemotherapy for advanced or metastatic disease.
The Food and Drug Administration (FDA) has granted Orphan Drug designation to dactinomycin nanoparticle formulation (NanoSmart) for the treatment of Ewing’s sarcoma.
If genetic tests are only done on cancer tissue, as many as half of patients may not receive the most appropriate treatment for their cancer, according to new research.
Eisai announced results from a Phase 3 trial investigating the use of eribulin vs. dacarbazine in patients with advanced soft tissue sarcomas.
Treatment with pimecrolimus for eczema was found unlikely to increase the risk of cancer in children, according to a post-marketing study.
The Food and Drug Administration (FDA) has granted Orphan Drug designation to its antinuclear antibody (ANA) conjugated liposomal doxorubicin (NanoSmart Pharmaceuticals) intended to treat Ewing’s sarcoma, with potential expansion to other indications.
Janssen R&D and PharmaMar announced that the Food and Drug Administration (FDA) has granted Priority Review to the New Drug Application (NDA) for Yondelis (trabectedin).
Amgen announced that the Food and Drug Administration (FDA) has approved Xgeva (denosumab) for the treatment of hypercalcemia of malignancy (HCM) refractory to bisphosphonate therapy.
