Sign in Subscribe
Pharmaceutical industry

Gemzar Receives Approval for Fifth Indication: Treating Recurrent Epithelial Ovarian Cancer

Strategic Insights

— 1 min read

Prolonged cancer progression time and relief of cancer symptoms have been achieved with the use of Gemzar (gemcitabine) in combination with carboplatin for women suffering from recurrent epithelial ovarian cancer. Regulatory officials in several European markets have granted approval for this new indication, marking a significant milestone in the treatment of this aggressive disease. According to Jacobus Pfisterer, MD, PhD, of the University of Kiel, this new treatment option provides women with the ability to maintain everyday activities and return to a state of normalcy.

Key Takeaways:

  • Gemzar (gemcitabine) has received approval for a fifth indication, specifically for the treatment of recurrent epithelial ovarian cancer in combination with carboplatin.
  • Regulatory officials in European markets such as Germany, Sweden, Denmark, Finland, Belgium, Hungary, Portugal, and Romania have granted approval for this new indication.
  • The approval is based on data from an international study conducted by the AGO (Arbeitsgemeinschaft Gynaekologische Onkologie) Ovarian Cancer Study Group, in collaboration with the National Cancer Institute of Canada - Clinical Trials Group and the European Organization for Research and Treatment of Cancer - Gynecological Cancer Group.
  • The study demonstrated a statistically significant improvement in time to disease progression for Gemzar in combination with carboplatin compared to carboplatin alone.
  • Gemzar provides consistent clinical efficacy and manageable side effects across tumor types, offering a new innovative therapeutic option for women with recurrent ovarian cancer.
  • The approval of Gemzar for this new indication is a result of a collaborative effort between Eli Lilly and Co., regulatory officials, and various research organizations.

Statistics:

  • The study included over 100 trial sites across Europe and beyond.
  • The data from the study were presented at the 40th annual meeting of the American Society of Clinical Oncology.
  • Time to disease progression was the primary endpoint of the study, and Gemzar in combination with carboplatin showed a statistically significant improvement compared to carboplatin alone.
  • The approval of Gemzar for recurrent epithelial ovarian cancer is a significant milestone in the treatment of this aggressive disease.

Sources:

  • OBGYN & Reproduction Week editors
  • NewsRx.com & NewsRx.net
  • Eli Lilly and Co.
  • Jacobus Pfisterer, MD, PhD, University of Kiel
  • AGO (Arbeitsgemeinschaft Gynaekologische Onkologie) Ovarian Cancer Study Group
  • National Cancer Institute of Canada - Clinical Trials Group
  • European Organization for Research and Treatment of Cancer - Gynecological Cancer Group

Read more