Ariad Pharmaceuticals says that they initiated an NDA or New Drug Application for its investigational candidate drug, Brigatinib which is an anaplastic lymphoma kinase or ALK inhibitor used for the treatment of patients with ALK and non-small cell lung cancer (NSCLC). The drug particularly targets patients who are resistant to crizotinib.
Crizotinib with a trade name of Xalkori is distributed by Pfizer. It is an anti-cancer drug acting as ALK inhibitor and ROS-1 inhibitor. It is currently the approved treatment for non-small cell lung carcinoma.
The company submitted an application to FDA to seek marketing approval for their candidate drug.
The pharmaceutical company revealed that Brigatinib achieved a breakthrough therapy based from the designation by FDA for the treatment of patients with ALK and NSCLC. Ariad was granted an orphan drug designation by FDA. The company noted that they are seeking an accelerated approval for brigatinib. They also requested a priority review for their application.
Paris Panayiotopoulos, Chief Executive Officer and the President of Ariad said that so far, they are ahead of their previously announced schedule for the submission of NDA for Brigatinib. They are also grateful that they achieve a breakthrough status from FDA. This gives them the opportunity to request for a priority review for their submission process.
Panayiotopoulos added that if granted brigatinib will become an effective medicine for ALK + NSCLC patient who have become intolerant or resistant to crizotinib therapy. This breakthrough also provides additional hope for the patient and their family.
Deadly Lung Cancers
According to the American Cancer Society, Lung cancer is divided into two categories, Small cell lung cancer and Non-small cell lung cancer. Among the two, majority of cases are non-small lung cancer which is approximately 80% to 85% of lung cancers. Non-small cell lung cancer is further subdivided into large cell carcinoma, small cell carcinoma and adenocarcinoma.
The Centers for Disease and Control Prevention noted that in 2012, over 210,828 people were diagnosed with lung cancer in the United States. At the same year, approximately, 157,423 people died of Lung cancer. In US, more people died of lung cancer than any other types of cancer.
Thus, Brigatinib will help improve the survival rate of patients suffering from lung cancer. Patients, who are resistant to crizotinib, will have another treatment alternative. This will give lung cancer patients, more treatment options that will help lessen the morbidity and mortality rates.