Brain Cancer | Specialty

FDA Grants 3 Rare Pediatric Disease Designations to STAT3 Inhibitor WP1066

January 7th 2021

January 7, 2020 - The FDA has approved the request submitted by Moleculin Biotech, Inc. for rare disease designations to be granted their drug candidate WP1066, an agent that appears to directly elicit tumor cell death and rouse the immune system to eliminate tumors.

Japanese Approval Sought for Oncolytic Virus Teserpaturev for Malignant Glioma

January 5th 2021

January 5, 2020 - A new drug application has been submitted to Japan’s Ministry of Health, Labour, and Welfare for the oncolytic virus teserpaturev for use in the treatment of patients with malignant glioma.

Nivolumab Plus Temozolomide/Radiotherapy Misses OS End Point in Glioblastoma Multiforme 

December 23rd 2020

December 23, 2020 — Nivolumab in combination with temozolomide and radiation treatment failed to result in a statistically significant improvement in overall survival in patients with newly diagnosed glioblastoma multiforme with MGMT promoter methylation following surgical resection of the tumor.

FDA Gives Green Light to IND for Berubicin for Glioblastoma Multiforme

December 22nd 2020

December 22, 2020 — The FDA has approved an investigational new drug application for berubicin for the treatment of patients with glioblastoma multiforme.

FDA Grants PTC596 Multiple Designations for Leiomyosarcoma, Glioma

November 18th 2020

November 18, 2020 - The FDA has granted a fast track designation and an orphan drug designation to the orally bioavailable small molecule tubulin-binding agent PTC596 for potential use in patients with leiomyosarcoma; the agent also received a rare pediatric disease designation and an orphan drug designation for potential use in patients with diffuse intrinsic pontine glioma.

Cancer Vaccine AV-GBM-1 Improves PFS in Newly Diagnosed Glioblastoma

November 17th 2020

November 17, 2020 - AV-GBM-1, a personalized cancer vaccine, demonstrated an improvement in progression-free survival in patients with newly diagnosed glioblastoma.

Dr. Lwin on the Design of the LEAP-005 Trial in Pretreated Advanced Solid Tumors

October 20th 2020

Zarnie Lwin, MBBS, FRACP, discusses the design of the phase 2 LEAP-005 trial in previously treated patients with advanced solid tumors.

FDA Grants Nivatrotamab Orphan Drug Status for Pediatric Neuroblastoma

October 8th 2020

The FDA has granted an orphan drug designation and rare pediatric disease designation to the bispecific antibody nivatrotamab for the treatment of patients with neuroblastoma.

FDA Issues Refusal to File Letter for Omburtamab for Pediatric Metastatic Neuroblastoma

October 5th 2020

The FDA has issued a Refusal to File letter regarding the biologics license application for the investigational B7-H3–targeting monoclonal antibody omburtamab for the treatment of pediatric patients with central nervous system/leptomeningeal metastasis from neuroblastoma.

Dr. Hormigo on the Current Treatment Landscape of Glioblastoma

August 26th 2020

Adilia Hormigo, MD, PhD, discusses the current treatment landscape of glioblastoma.

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