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FDA Approves Innovent Biologics’ Groundbreaking Drug for Advanced Pancreatic Cancer

China-based biopharmaceutical MNC Innovent Biologics has renently announced that United States Food and Drug Administration (FDA) granted final approval to its experimental drug for treating advanced pancreatic cancer or metastatic pancreatic ductal adenocarcinoma (PDAC).

Metastatic Pancreatic ductal adenocarcinoma that has spread starts in the cells that line the pancreas' ducts. The pancreas, which is in the abdomen, is essential for digestion and keeping blood sugar levels steady. Metastatic pancreatic ductal adenocarcinoma refers to the spread of pancreatic cancer cells to other parts of the body, such as the liver or lungs.

In simple terms, it means that cancerous cells that started in the pancreas have spread to other parts of the body. It's harder to treat cancer that has spread to other parts of the body after it has started to grow in this way.

The company further informed that IBI343 has already received FDA approval as an investigational new drug for PDAC treatment, at the ASCO 2024 Annual Meeting, where it shared the drug's preliminary Phase 1 trial results.

Dr. Hui Zhou, Senior Vice President of Innovent Biologics Inc., stated that pancreatic cancer is highly malignant and difficult to diagnose early. "At present, the treatment of advanced pancreatic cancer is still based on systemic chemotherapy. The clinical options for the second-line treatment are particularly limited, with a response rate of only  6%–16% and a median survival period of only about 3–6 months," he added.

We must address the urgent clinical needs. This single-agent therapy, the world's first CLDN18.2 ADC to obtain FTD certification in this difficult-to-treat cancer, shows encouraging efficacy and tolerable safety in the late-line treatment of patients with advanced pancreatic cancer.

"We will continue to confirm its efficacy and safety in this disease in subsequent clinical trials, as well as explore IBI343 in combination therapy and other solid tumors, including gastric cancer," he added.

Pancreatic cancer is one of the most malignant tumours of the digestive system, with a 5-year survival rate of about 10%. In recent years, the incidence of pancreatic cancer has increased, but the early diagnosis rate is still low, seriously endangering human life and health. At present, the treatment of advanced pancreatic cancer is still based on systemic chemotherapy. Currently, the first-line treatment options mostly use fluorouracil (5-FU) or gemcitabine-based chemotherapy. In the second-line treatment, clinical options are very limited, mainly alternatives to the first-line regimen, and the median survival period is only about 3 to 4 months. Claudin, a member of the tight junction molecule family, is a key structural and functional component of epithelial tight junctions. The gastric mucosa normally burys CLDN18.2, but when cancer grows, it breaks down tight junctions and makes CLDN18.2 epitopes on the membrane of tumour cells visible. CLDN18.2 is present in 50% to 70% of pancreatic cancer patients, making it a highly scrutinised target.

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