lunedì, 14 settembre 2026

Notizie AIOM – anno XVI n. 657

FDA Grants Frontline Avelumab/Axitinib Breakthrough Designation for RCC

December 21, 2017 - The FDA has granted the PD-L1 inhibitor avelumab a breakthrough therapy designation for use in combination with the VEGF inhibitor axitinib in treatment-naïve patients with advanced renal cell carcinoma (RCC). The designation, which will expedite ...
Leggi tutto

FDA Grants Adjuvant Dabrafenib/Trametinib Priority Review for BRAF+ Melanoma

December 22, 2017 - The FDA has granted a priority review to a supplemental new drug application (sNDA) for the use of dabrafenib combined with trametinib as an adjuvant treatment for patients with BRAF V600E– or V600K–positive stage III melanoma following complete ...
Leggi tutto

FDA Approves Stereotactic Radiotherapy System for Breast Cancer

December 22, 2017 - The FDA has approved a novel breast-specific stereotactic body radiotherapy (SBRT) device known as GammaPod as a treatment for patients with early breast cancer, based on findings from a 17-patient study. In the small clinical trial, GammaPod was effectively ...
Leggi tutto

FDA Updates Nilotinib CML Label With Discontinuation Provision

December 22, 2017 - The FDA has updated the label for nilotinib with a provision stipulating that patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP) who have received the BCR-ABL tyrosine kinase inhibitor for at least ...
Leggi tutto

FDA Approval Sought for Ivosidenib in IDH1+ AML

December 26, 2017 - A new drug application (NDA) has been submitted for ivosidenib (AG-120) for patients with relapsed/refractory IDH1-mutant acute myeloid leukemia (AML), according to a statement from Agios Pharmaceuticals, the company developing the targeted therapy. The ...
Leggi tutto

FDA Grants Priority Review to Novel Iobenguane I-131 Agent for Rare Neuroendocrine Tumors

December 29, 2017 - The FDA has granted a priority review designation to a novel version of the radiopharmaceutical iobenguane I-131 for patients with malignant or recurrent pheochromocytoma or paraganglioma (PPGL), according to a statement from Progenics Pharmaceuticals, ...
Leggi tutto

FDA Grants Priority Review to Frontline Brentuximab Vedotin for Hodgkin Lymphoma

January 2, 2018 - The FDA has granted a priority review to a supplemental biologics license application (sBLA) for brentuximab vedotin in combination with Adriamycin, vinblastine, and dacarbazine (AVD) as a frontline treatment for advanced classical Hodgkin lymphoma, according ...
Leggi tutto

FDA Grants Frontline Eltrombopag Breakthrough Designation for Severe Aplastic Anemia

January 4, 2018 - The FDA has granted a breakthrough therapy designation to eltrombopag for use in combination with standard immunosuppressive therapy as a first-line treatment for patients with severe aplastic anemia (SAA). The small molecule thrombopoietin receptor agonist ...
Leggi tutto

Ipilimumab Approaches EU Approval for Pediatric Melanoma

December 18, 2017 - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of ipilimumab for the treatment of pediatric patients aged 12 years and older with unresectable or metastatic melanoma, according to Bristol-Myers ...
Leggi tutto

Orphan medicines in the EU – leaving no-one behind

December 21, 2017 - There are over 6,000 rare diseases and it is estimated that around 30 million people in the European Union (EU) suffer from one of them. Treating these patients can be very difficult, because there are only few medicines available. This represents a huge ...
Leggi tutto