Boehringer’s lung cancer drug Vargatef sees EU approval
pharmafile | November 28, 2014 | News story | Sales and Marketing | Boehringer, EU, Europe, IPF, NSCLC, lung cancer, nintedanib, ofev, vargatef
Boehringer Ingelheim’s nintedanib has received its second nod in Europe this month with the European Commission approving it for the treatment of lung cancer.
The drug will be marketed as Vargatef and is indicated for the treatment of non-small cell lung cancer (NSCLC) adenocarcinoma after first-line chemotherapy, when used in combination with docetaxel.
“The approval of nintedanib offers a much-needed new treatment option for adult lung cancer patients with advanced adenocarcinoma in the second-line setting,” says Dr Martin Reck, the lead investigator in the drug’s LUME-Lung 1 trial.
Patients using Vargatef and docetaxel together experienced overall survival of more than a year – 12.6 months – compared to 10.3 months on docetaxel alone. Boehringer also says that the treatment demonstrates a “manageable adverse event profile without further compromising patients’ overall health-related quality of life”.
Adenocarcinoma is the most common type of lung cancer and the majority of patients are diagnosed in an advanced stage. Most patients will experience disease progression after first-line chemotherapy.
Boehringer is putting a lot of stock in nintedanib as the drug continues to prove it can be quite versatile. Trials are currently underway for its use in colorectal, ovarian, kidney and liver cancer, as well as mesothelioma.
Vargatef is the second approved treatment from Boehringer’s burgeoning oncology portfolio. The first to be approved was Giotrif (afatinib), another NSCLC treatment.
IPF approval
Indeed it has been a good month for nintedanib, as earlier this week it was also recommended for approval for the treatment of idiopathic pulmonary fibrosis (IPF) under the brand name Ofev by the EMA’s Committee for Medicinal Products for Human Use (CHMP).
If it gets full approval from the regulator it will become only the second treatment available in Europe for the fatal and poorly-understood lung disease – following Roche’s Esbriet (pirfenidone), which has been on the market since 2011.
Both drugs also recently received FDA approval on the same day in the US.
George Underwood
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