Onivyde receives positive CHMP opinion for pancreatic cancer treatment

Posted: 25 July 2016 | | No comments yet

The positive opinion is based on a pivotal Phase 3 study showing that Onivyde combined with chemotherapy significantly increased overall survival in patients with metastatic pancreatic cancer…

The positive opinion is based on a pivotal Phase 3 study showing that Onivyde, combined with chemotherapy, significantly increased overall survival in patients with metastatic pancreatic cancer after previous gemcitabine based therapy.

pancreatic cancer

Shire plc today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the marketing authorisation for the use of Onivyde (irinotecan pegylated liposomal formulation) also known as nal-IRI or MM-398, for the treatment of metastatic adenocarcinoma of the pancreas, in combination with 5-fluorouracil (5-FU) and leucovorin, in adult patients who have progressed following gemcitabine based therapy.

“There has been little improvement in the prognosis for patients with metastatic pancreatic cancer in over 20 years. We therefore welcome the CHMP positive opinion for Onivyde, a regulatory milestone which brings us a step closer to helping patients with this devastating disease,” said Philip J. Vickers, Ph.D., Head of R&D, Shire.

Pancreatic cancer is the third leading cause of cancer death and there are limited treatment options available. In September 2015, the European Society of Medical Oncology (ESMO) stated that use of Onivyde when available in all countries, may be the best option for second-line treatment of these patients following gemcitabine-based therapy.

Pancreatic cancer is a significantly underserved disease in Europe and almost always fatal. Half of people diagnosed with pancreatic cancer are diagnosed at Stage 4, which is advanced metastatic disease and no longer curable.

Late diagnosis common for pancreatic cancer 

The signs and symptoms of pancreatic cancer are non-specific; common presenting symptoms include jaundice, abdominal pain, weight loss, steatorrhoea, and new-onset diabetes. However, these symptoms may not appear until the disease has spread locally or metastasized. Therefore, approximately 80% of patients are not candidates for surgery upon diagnosis.

Even though it accounts for less than three percent of all cancer cases, pancreatic cancer is the seventh leading cause of cancer death worldwide, and the third in Europe. Worldwide, pancreatic cancer prognosis is typically poor, with an estimated 337,900 new cases and 330,400 deaths each year.

First port of call and second-line treatment

Gemcitabine-based therapy is commonly used as a first-line treatment for patients with metastatic disease or locally advanced disease who cannot be treated with surgery.

“The CHMP positive opinion confirms the strength of the Phase 3 NAPOLI-1 data for the use of Onivyde combined with 5-FU and leucovorin to treat metastatic pancreatic cancer patients in the post-gemcitabine setting.” said Professor Thomas Seufferlein, M.D., University of Ulm, Germany.

“This data will allow physicians to better evaluate options for extending overall survival of patients diagnosed with a very difficult-to-treat cancer.”