Complete Story
07/24/2018
Recent Oncology Related FDA Approvals/Changes
- FDA approved ivosidenib (Tibsovo, Agios Pharmaceuticals, Inc.) for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. More Information. July 20, 2018 (1)
- FDA approved biosimilar filgrastim-aafi (Nivestym) a biosimilar to Neupogen (filgrastim). More Information. July 20, 2018 (1)
- FDA expanded the indication for ribociclib (Kisqali, Novartis Pharmaceuticals Corporation) in combination with an aromatase inhibitor for pre/perimenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy. More Information. July 18, 2018 (1)
- FDA approved enzalutamide (XTANDI, Astellas Pharma US, Inc.), for patients with castration-resistant prostate cancer (CRPC). More Information. July 13, 2018 (1)
- FDA granted accelerated approval to ipilimumab (YERVOY, Bristol-Myers Squibb Company Inc.) for use in combination with nivolumab for the treatment of patients 12 years of age and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. More Information. July 10, 2018 (1)
- FDA has limited the use of Tecentriq and Keytruda for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing therapy. More Information. June 19, 2018 (2)
- FDA approved encorafenib and binimetinib (BRAFTOVI and MEKTOVI, Array BioPharma Inc.) in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. More Information. June 27, 2018 (2)
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