Nemvaleukin Alfa Fast Tracked for Mucosal Melanoma
Nemvaleukin alfa is an investigational, engineered fusion protein consisting of modified interleukin-2 (IL-2) and the high-affinity IL-2 alpha receptor chain.
Oncology
Nanoparticle Albumin-Bound mTOR Inhibitor Gets Priority Review for Ultra-Rare Sarcoma
Nab-sirolimus is an mTOR inhibitor bound to human albumin.
Keytruda Combo Approved for High-Risk Early-Stage Triple-Negative Breast Cancer
The approval was based on data from the phase 3 KEYNOTE-522 trial, which included 1174 patients with newly diagnosed previously untreated high-risk early-stage TNBC.
Neulasta Ad Claims Misleading, May Undermine Biosimilar Use, Says FDA
The ad claims that there is a higher risk of febrile neutropenia when pegfilgrastim is administered via prefilled syringe vs Neulasta Onpro on-body injector.
Darzalex Faspro, Pomalidomide, Dexamethasone Combo Approved for Multiple Myeloma
The approval was based on data from the phase 3 APOLLO trial.
Padcev Gets Full Approval, Expanded Indication for Urothelial Cancer
Full approval was granted based on overall survival data from a confirmatory trial.
Keytruda Indication for Advanced Gastric Cancer Withdrawn
In September 2017, the FDA granted accelerated approval to Keytruda for recurrent locally advanced or metastatic gastric or GEJ adenocarcinoma.
Rylaze Approved For Patients Allergic to E. coli-Derived Asparaginase Products
Rylaze will be supplied as single-dose vials containing 10mg/0.5mL solution of asparaginase erwinia chrysanthemi (recombinant)-rywn and is expected to be available in mid-July 2021.
Devimistat Granted Orphan Drug Status for Biliary Cancer
Devimistat targets the mitochondrial tricarboxylic acid cycle selectively in cancer cells.
Stivarga Now Supplied in New Packaging to Improve Dispensing
The new packaging was designed to help accommodate dispensing.
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