Potential Med Errors Prompt FDA Action on Vinca Alkaloid Labeling
Chemotherapy agents such as vincristine sulfate injection, vinblastine sulfate injection, and vinorelbine tartrate injection should only be prepared in IV infusion bags.
CNS Cancers
New Drugs Approved in 2020
Visit our New Drug Products page to stay up-to-date on the latest drug approvals.
MPR Weekly Dose Podcast Episode 60
This week the FDA and the WHO have a back and forth over remdesivir; Who should get a COVID vaccine; Xolair and Hetlioz have approval expansions; And a novel neuroblastoma treatment gets accelerated approval.
Novel Treatment Gains Accelerated Approval for Relapsed/Refractory Neuroblastoma
Approval was based on results from two phase 2 single-arm, open-label trials that demonstrated overall response rate and duration of response.
FDA Grants Orphan Drug Status to Berubicin for Malignant Gliomas
he designation is supported by data from a phase 1 trial conducted by Reata Pharmaceuticals in 2016. Findings from the study showed 44% of patients treated with berubicin (n=11 out of 25) experienced a statistically significant improvement in progression free survival.
Pedmark Receives Priority Review for Prevention of Cisplatin-Induced Ototoxicity
The application is supported by data from 2 pivotal open-label, randomized phase 3 trials (SIOPEL 6 and ACCL0431), which compared the efficacy of sodium thiosulfate plus cisplatin to cisplatin alone for the prevention of cisplatin-induced hearing loss.
Phase 3 Study of Investigative Glioblastoma Tx Halted
AbbVie has halted enrollment in all ongoing studies of depatuxizumab mafodotin, after an Independent Data Monitoring Committee (IDMC) recommended a phase 3 study of the treatment be stopped due to a lack of survival benefit.
Neoadjuvant PD-1 Blockade Seems Effective in Glioblastoma
Neoadjuvant administration of programmed cell death protein 1 (PD-1) blockade seems to enhance local and systemic antitumor immune response in glioblastoma, according to a study published online in Nature Medicine.
Novel Glioblastoma Treatment Granted Orphan Drug Designation
Moleculin Biotech announced that the Food and Drug Administration (FDA) has granted Orphan Drug Designation to WP1066 for the treatment of glioblastoma. WP1066 is an immuno-stimulating STAT3 (signal transducers and activators of transcription) inhibitor being investigated as a potential treatment for brain tumors, pancreatic cancer, and acute myeloid leukemia. In preclinical models, the inhibition of…
Sex Differences ID’d in Response to Glioblastoma Treatment
HealthDay News — Sex differences have been identified in response to therapy among glioblastoma (GBM) patients, according to a study published in the January 2 issue of Science Translational Medicine. Wei Yang, PhD, from the Washington University School of Medicine in St. Louis, and colleagues used a quantitative image-based measure of response to examine the…
