Lartruvo Pulled From Market, Access Program to Be Established
Lilly is working to establish an access program to provide Lartruvo to patients who wish to continue treatment.
Diagnosis & Disease Information
FDA Places Clinical Hold on Venetoclax Trials for Multiple Myeloma
The Food and Drug Administration (FDA) has placed a partial hold on all clinical trials evaluating venetoclax (Venclexta; AbbVie and Genentech) for the treatment of multiple myeloma. This was prompted after a review of data from the phase 3 BELLINI trial (M14-031) showed a higher proportion of deaths in the venetoclax treatment arm compared with…
Levoleucovorin Injection Recalled Due to Presence of Particulate Matter
Mylan is recalling 2 lots of Levoleucovorin Injection 250mg/25mL due to the presence of copper salts identified during 12-month stability testing.
Pexidartinib Gets Priority Review for Tenosynovial Giant Cell Tumor
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 for Desmoid Tumors Ups Progression-Free Survival
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.
Nirogacestat Gets Fast-Tracked for the Treatment of Desmoid Tumors
The Company is planning a Phase 3 study (DeFi) sometime in the first half of 2019.
Addition of Elotuzumab Ups PFS in Refractory Multiple Myeloma
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.
New Formulation of Levoleucovorin Gets FDA Approval
Khapzory will be supplied in single-dose vials containing 175mg and 300mg of levoleucovorin lyophilized powder for reconstitution before intravenous administration.
Treatment for Rare Pediatric Cancer Granted Orphan Drug Designation
CLR 131 is an investigational radioiodinated Phospholipid Drug Conjugate (PDC) drug candidate that delivers cytotoxic radiation directly and selectively to malignant cells.
Adipocytes May Clear Daunorubicin, Contribute to Poorer Survival Outcomes
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.
