New and updated indications are approved by FDA for temozolomide under Project Renewal

Nov 2023: Under Project Renewal, an Oncology Centre of Excellence (OCE) initiative aimed at updating labelling information for older oncology drugs to ensure information is clinically meaningful and scientifically up-to-date, the Food and Drug Administration (FDA) approved updated labelling for temozolomide (Temodar, Merck). Under this experimental programme, this is the second medication to have its label updated. Capecitabine (Xeloda) was the first medication approved under Project Renewal.

Through the joint efforts of Project Renewal, early-career scientists and external oncology specialists analyse published literature in order to get firsthand experience in the selection, curation, and evaluation of data for independent FDA review. The goal of Project Renewal is to maintain the most recent labelling for older, frequently prescribed oncology medications while increasing public knowledge of drug labelling as a source of information and offering openness on the FDA’s evidentiary requirements and evaluation procedure.

Temozolomide is now approved for the following new and revised indications:

• adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma.
• treatment of adults with refractory anaplastic astrocytoma.

One approved indication for temozolomide remains the same:

• treatment of adults with newly diagnosed glioblastoma, concomitantly with radiotherapy and then as maintenance treatment.

Additional labeling revisions include:

• The dosage regimen is revised and updated for newly diagnosed glioblastoma and refractory anaplastic astrocytoma.
• For Temodar capsules, information on risks from exposure to opened capsules is added under Warnings and Precautions.
• Patient Counseling Information section and the Patient Information document are updated and revised.

Susan Hau

Website |  + postsBio ⮌

Susan Hau is a distinguished researcher in the field of cancer cell therapy, with a particular focus on T cell-based approaches and cancer vaccines. Her work spans several innovative treatment modalities, including CAR T-cell therapy, TIL (Tumor-Infiltrating Lymphocyte) therapy, and NK (Natural Killer) cell therapy.

Hau's expertise lies in cancer cell biology, where she has made significant contributions to understanding the complex interactions between immune cells and tumors.

Her research aims to enhance the efficacy of immunotherapies by manipulating the tumor microenvironment and exploring novel ways to activate and direct immune responses against cancer cells.

Throughout her career, Hau has collaborated with leading professors and researchers in the field of cancer treatment, both in the United States and China.

These international experiences have broadened her perspective and contributed to her innovative approach to cancer therapy development.

Hau's work is particularly focused on addressing the challenges of treating advanced and metastatic cancers. She has been involved in clinical trials evaluating the safety and efficacy of various immunotherapy approaches, including the promising Gamma Delta T cell therapy.

• Susan Hau

  https://cancerfax.com/author/susan/

  Datopotamab deruxtecan-dlnk is approved by the USFDA for EGFR-mutated non-small cell lung cancer
• Susan Hau

  https://cancerfax.com/author/susan/

  PiggyBac Transposon System: A Revolutionary Tool in Cancer Gene Therapy
• Susan Hau

  https://cancerfax.com/author/susan/

  Neoadjuvant and adjuvant pembrolizumab is approved by the USFDA for resectable locally advanced head and neck squamous cell carcinoma
• Susan Hau

  https://cancerfax.com/author/susan/

  Taletrectinib is approved by the USFDA for ROS1-positive non-small cell lung cancer

• Comments Closed
• November 23rd, 2023