Brain Metastases Archives

Six Companies Hit the Clinic with Innovative Therapeutic Candidates

Brain Metastases, Business, Clinical Trials, FDA, GlaxoSmithKline, Hematologic malignancies, Investigational New Drug (INDs) submissions, R&D, Sarcomas, Solid Tumors, Studies, Transplants

TScan Therapeutics secured clearance from the U.S. Food and Drug Administration for the company’s investigational new drug application to assess TSC-100 in treating patients with hematologic malignancies undergoing allogeneic hematopoietic cell transplantation (HCT).

January 24, 2022/by BioSpace

FDA Action Alert: Bristol Myers Squibb/Juno, Seattle Genetics, BioMarin and Tricida

Adeno-Associated Virus (AAV), B Cell Lymphomas, Biologics License Application (BLA), Brain Metastases, CAR-T Therapy, Chronic Kidney Disease, Diffuse large B-cell lymphoma (DLBCL), FDA, FDA/Regulatory, Hemophilia A, HER2-positive breast cancer, Immunotherapy, New Drug Applicationa, Project Orbis, Quarterly results, T-Cells

The U.S. Food and Drug Administration’s approval-review schedule for August includes the Biologics License Application for Bristol Myers Squibb and Juno Therapeutics’ lisocabtagene maraleucel (liso-cel) for relapsed or refractory large B-cell lymphoma after at least two previous therapies.

August 17, 2020/by Andrew Humphreys

U.S. FDA Approves Takeda’s Alunbrig as First-Line Treatment Option for Rare Form of Lung Cancer

Anaplastic Lymphoma Kinase-Positive (ALK+) Non-Small Cell Lung Cancer, Approvals, Brain Metastases, FDA, FDA/Regulatory, Tests, Tyrosine kinase inhibitors

The U.S. Food and Drug Administration approved Takeda Pharmaceutical Company Limited’s Alunbrig (brigatinib) for adult patients with anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer as detected by an FDA-approved test.

May 22, 2020/by Business Wire

U.S. FDA Approves Seattle Genetics’ Tukysa for People with Advanced Unresectable or Metastatic HER2-Positive Breast Cancer

Approvals, Brain Metastases, FDA, FDA Oncology Center of Excellence, FDA/Regulatory, New Drug Application (NDA), Project Orbis, Small Molecules, Unresectable or Metastatic HER2-Positive Breast Cancer

The U.S. Food and Drug Administration granted approval to Seattle Genetics Inc.’s Tukysa tablets in combination with trastuzumab and capecitabine for adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.

April 17, 2020/by Business Wire