Research & Clinical Trials

New Drug Ofev Gaining Momentum in Fight Against Mesothelioma

Written By:
Dec 08, 2014
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Written By: Tim Povtak,
December 8, 2014

Mesothelioma patients battling shortness of breath, a symptom that makes everyday activities increasingly difficult, may soon find relief with nintedanib, a new anti-cancer drug shown to relieve respiratory distress.

Nintedanib recently received approval from the U.S. Food and Drug Administration (FDA) for the treatment of idiopathic pulmonary fibrosis (IPF), a lung scarring condition with similarities to asbestosis.

German-based drugmaker Boehringer Ingelheim markets the drug under the brand name Ofev. The European Commission also granted the marketing of the drug as Vargatef for use with docetaxel to combat lung cancer.

Researchers now are conducting multicenter, mesothelioma clinical trials using nintedanib in San Francisco, Cleveland, Columbus, and Pittsburgh, along with cities in several countries outside the U.S.

It is a phase II study designed to measure the efficacy and safety of the drug in combination with a chemotherapy regimen of pemetrexed and cisplatin. It is a double-blind, randomized study where a percentage of patients receive only the chemotherapy regimen.

The clinical trial began in 2013 and is expected to end by May 2016.

Nintedanib Expands Treatment for Multiple Cancers

Previously, the FDA granted Ofev orphan product and fast track designations to speed its approval process, which was not originally expected until 2015.

Nintedanib is a protein inhibitor with the ability to block the multiple pathways that lead to scaring of lung tissue, a problem with IPF, asbestosis and mesothelioma.

During three separate clinical trials involving 1,231 patients with IPF, nintedanib improved the volume of air the majority of patients could exhale after taking a deep breath.

FDA Office of Evaluation Deputy Director Mary Parks, M.D., said Ofev approval “expands the available treatment options for patients with idiopathic pulmonary fibrosis, a serious, chronic problem.”

Unexplained shortness of breath and prolonged dry coughing are early symptoms of pleural mesothelioma. They signal early problems with the lining around the lungs and scaring of the lungs.

Drug Is Expanding Survival in Some Lung Cancer Patients

In addition to the mesothelioma trial, researches are investigating nintedanib’s effects on other solid tumors. There are ongoing phase III trials involving advanced, non-small cell lung cancer, colorectal cancer and ovarian cancer. There are phase II trials involving mesothelioma, liver and kidney cancer.

Nintedanib, when combined with docetaxel, another cancer-fighting medication that targets genetic DNA, demonstrated extended survival time for advanced lung cancer patients in a trial involving more than 1,300 participants. It led to fast track approval by the European Union.

“The clinical data has shown that patients receiving nintedanib, plus docetaxel, experienced over one-year survival with no compromise to their quality of life,” said Martin Reck, Ph.D., head of thoracic oncology at Lung Clinic Grosshansdorf and lead trial investigator. “This adds a much-needed treatment option for lung cancer patients.”

The use of nintedanib for lung cancer is designed as second-line treatment after first-line chemotherapy, filling a significant void in the typical therapy regimen.

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