Production & Manufacturing
Process & Production

Ariad seeks European approval for NSCLC drug brigatinib

PBR Staff Writer Published 07 February 2017

Ariad Pharmaceuticals is seeking approval in Europe for brigatinib to treat adult patients anaplastic lymphoma kinase (ALK+) non-small cell lung cancer (NSCLC) who have been earlier treated with crizotinib.

The company has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA).

Ariad’s US marketing application is currently under the US Food and Drug Administration review with an action date of 29 April 2017.

The EMA submission was supported by positive clinical data from brigatinib’s phase 1/2 and phase 2 trials.

Ariad is also carrying out Phase 3 trials to assess the drug’s efficacy and safety compared to crizotinib in patients with advanced ALK+ NSCLC who have not received prior treatment with an ALK inhibitor.

Ariad president and CEO Paris Panayiotopoulos said the MAA submission to the EMA is one of several recent milestones highlighting its investment in internally discovered rare cancer therapies. 

Panayiotopoulos said: “Since announcing our definitive agreement to combine with Takeda, we remain focused on our accountability to our patients by propelling brigatinib forward and by preparing for its anticipated U.S. launch.”

Brigatinib secured the FDA’s Breakthrough Therapy designation for ALK+ NSCLC patients whose cancer are resistant to crizotinib. It also has orphan drug designation for treatment of ALK+, ROS1+ and EGFR+ NSCLC.

Earlier this year, Takeda Pharmaceuticals has agreed to buy Ariad for $5.2bn. The deal is anticipated to close by the end of this month.

The acquisition would expand Takeda’s cancer holdings into solid tumors with two targeted therapies that include leukemia drug Iclusig (ponatinib) and the NSCLC drug brigatinib.