The National FDA Approval for Lilly's CYRAMZA® For Advanced Gastric Cancer Treatment

FDA Approval for Lilly’s CYRAMZA® For Advanced Gastric Cancer Treatment

Nov 07, 2014 Ruchira Dhoke News 0

“Gastric or a stomach cancer is a major health problem being considered as fifth most common cancer in the world and the third-leading cause of cancer death. The stomach is the site where the cancer cells are formed in gastric cancer and develops slowly, usually over many years, which often goes undetected.As the disease cancer advances, it spreads to organs such as the liver, lungs and bones via the bloodstream.

Adenocarcinoma is the most common type of stomach cancer which starts from one of the common cell types found in the lining of the stomach.”

The U.S. Food and Drug Administration (FDA) has approved Eli Lilly and Company’sCYRAMZA^® (ramucirumab) in combination with paclitaxel (a type of chemotherapy) as a treatment for people with advanced or metastatic gastric (stomach) or gastroesophageal junction (GEJ) adenocarcinoma whose cancer has progressed on or after prior fluoropyrimidine- or platinum-containing chemotherapy.

Richard Gaynor, MD, senior vice president of product development and medical affairs for Lilly Oncology said in a press releasethat:

This FDA approval of Cyramza represents another milestone for people battling this devastating and difficult-to-treat disease. Lilly is pleased to continue delivering on its commitment to provide new treatment options to people living with cancer and those who care for them.

The drug ramucirumab plus paclitaxel compared with placebo plus paclitaxel was evaluated in patients with locally advanced or metastatic gastric or GEJ adenocarcinoma, whose cancer progressed after treatment chemotherapy in a multinational, randomized, double-blinded, placebo-controlled phase 3 trial.

665 patients were randomised throughout 27 countries in North America, South America, Europe, Australia, and Asian for the study. The trial also known as RAINBOW PAHSE III was the first phase 3 study to demonstrate the survival benefit with a biologic used in combination with chemotherapy in this setting.

After evaluating the efficacy endpoints in the trial, thelabelling for CYRAMZA contains a Boxed Warning regarding increased risk of haemorrhage, including severe and sometimes fatal haemorrhagic events. A patient experiencing bleeding should immediately discontinue CYRAMZA.

The CYRAMZA has been granted Orphan Drug Designation by the FDA. Orphan drug status is given in the U.S. by the FDA’s Office of Orphan Products Development (OOPD) to medicines that show promise for the treatment of rare diseases.

Know more about CYRAMZA^® (ramucirumab)

CYRAMZA approved for the treatment of people with advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose cancer has progressed on or after prior fluoropyrimidine- or platinum-containing chemotherapy as a single agent, or in combination with paclitaxel (a type of chemotherapy).

CYRAMZA is an antiangiogenic therapy where the vascular endothelial growth factor (VEGF) Receptor 2 antagonist specifically binds and blocks activation of VEGF Receptor 2, by blocking the binding of VEGF receptor ligands VEGF-A, VEGF-C, and VEGF-D.

CYRAMZA inhibited angiogenesis in an in vivo animal model.

Chemotherapy, Cyramza, FDA, gastric cancer, stomach cancer

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Ruchira Dhoke

A qualified medical microbiologist with an avidity to read enchant a deep passion for creating a good impacting masterpiece with my words .I am very fond of good old English literature and like listening to music and paint in my free time.