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FDA Approval for Advanced Gastric Cancer Treatment: A New Option for Patients – The Babak Lab
Nov 5, 2024, 14:59

FDA Approval for Advanced Gastric Cancer Treatment: A New Option for Patients – The Babak Lab

The Babak Lab posted on LinkedIn:

FDA Approval for Advanced Gastric Cancer Treatment: A New Option for Patients

On October 18, 2024, the FDA approved zolbetuximab-clzb (Vyloy) in combination with chemotherapy for HER2-negative, CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma. This decision, backed by strong trial results, offers a new path for patients with advanced stages of this challenging cancer type.

Key Highlights:

  • Targeted Treatment
    Zolbetuximab-clzb directly targets CLDN18.2, a protein expressed in some gastric cancer tumors.
    Improved Survival: In trials, patients showed a significant extension in both progression-free survival and overall survival.
  • Companion Diagnostic
  • FDA also approved the VENTANA CLDN18 Assay to ensure appropriate patient selection.

Trial Outcomes:

  • SPOTLIGHT Trial
    Patients treated with zolbetuximab had a median overall survival of 18.2 months compared to 15.5 months with standard chemotherapy.
  • GLOW Trial
    Survival extended to 14.4 months with zolbetuximab, versus 12.2 months with standard treatment.

Discussion Points:

  • How do you think this targeted approach might change the landscape of advanced gastric cancer treatment?
  • The FDA-approved VENTANA CLDN18 assay ensures that only patients with CLDN18.2-positive tumors receive zolbetuximab. What are your thoughts on the growing role of personalized diagnostics in cancer treatment?
  • Adverse reactions included nausea, vomiting, and neutropenia. How should oncologists balance potential benefits with these risks

Join the discussion! Leave your comments on how targeted therapies like zolbetuximab could shape the future of cancer care, especially for hard-to-treat cases like gastric cancer.

Read more in the original source.”

Maria Babak shared this post on LinkedIn adding:

“This FDA approval is a meaningful step forward for gastric cancer treatment, especially with the focus on precision targeting CLDN18.2. While the efficacy data is promising, the side effects remind us of the ongoing challenge in balancing effectiveness with quality of life. It’ll be interesting to see how targeted diagnostics like this shape future treatment pathways.”

Dr. Maria (Masha) Babak is the Head of The Babak Lab and an Assistant Professor at the City University of Hong Kong. In November 2020, she joined the City University of Hong Kong as an assistant professor. Dr. Babak received the Graeme Hanson-AsBIC Early Career Award in 2022.

Her research interests are at the intersection of chemistry, biology, and medicine, with a focus on the discovery and preclinical development of anticancer drugs for resistant and aggressive cancers with limited treatment options, such as malignant pleural mesothelioma and brain metastases. She received the Yvonne Award by OncoDaily in the “mentorship” category.