The combination of bempegaldesleukin (NKTR-214) and nivolumab (Opdivo) was granted a breakthrough therapy designation by the FDA for the treatment of patients with previously untreated unresectable or metastatic melanoma.
Regulatory
FDA Approval in TGCT, Breakthrough Designation in Melanoma, and More
An FDA approval in tenosynovial giant cell tumor, a breakthrough therapy designation in melanoma, and encouraging findings in trials in bladder cancer, lung cancer, and a cell-free DNA assay.
FDA Will Review Application Seeking Expansion of Keytruda’s Dosing Schedule
The U.S. Food and Drug Administration (FDA) has accepted for review six supplemental biologics license applications (sBLAs) seeking to expand the dosing schedule of Keytruda (pembrolizumab) so the medication can be administered every six weeks.
FDA Approval Sought for Extended Pembrolizumab Dosing Schedule for Select Indications
Source: OncLive, July 2019 The FDA has accepted 6 supplemental biologics license applications (sBLAs) for review to update the dosing schedule for pembrolizumab (Keytruda) to include an every-6-weeks option at…
Read More