The NDA is supported by data from the Phase 3 ENLIVEN study (N=120) which randomized patients with symptomatic TGCT to receive pexidartinib or placebo to evaluate the safety and efficacy of the treatment.
Sorafenib prolongs progression-free survival among patients with desmoid tumors, according to a study published in the December 20 issue of the New England Journal of Medicine.
The Company is planning a Phase 3 study (DeFi) sometime in the first half of 2019.
The researchers found that median progression-free survival was 10.3 and 4.7 months in the elotuzumab and control groups, respectively, after a minimum follow-up period of 9.1 months.
Khapzory will be supplied in single-dose vials containing 175mg and 300mg of levoleucovorin lyophilized powder for reconstitution before intravenous administration.
CLR 131 is an investigational radioiodinated Phospholipid Drug Conjugate (PDC) drug candidate that delivers cytotoxic radiation directly and selectively to malignant cells.
The researchers found that adipocytes absorbed and metabolized daunorubicin to daunorubicinol, which reduced its anti-leukemia effect. Daunorubicin conversion to daunorubicinol was confirmed in vivo in murine studies.
The researchers found that all participants reported a positive experience with aromatherapy massage.
Merrimack announced that the FDA has accepted for review the ANDA for generic Doxorubicin Hydrochloride (HCI) Liposome Injection.
The Food and Drug Administration has granted accelerated approval to Lartruvo (olaratumab) injection with doxorubicin to treat adults with certain types of soft tissue sarcoma (STS).
