2 Information about dacomitinib

Anticipated marketing authorisation indication

On 31 January 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product dacomitinib (Vizimpro, Pfizer), intended for the first-line treatment of adult patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations.

Dosage in the marketing authorisation

Based on the company submission, dacomitinib is given orally at a dosage of 45 mg until disease progression or unacceptable toxicity. Dacomitinib is available in 3 dose strengths: 45 mg, 30 mg and 15 mg.

Price

The price was submitted as commercial in confidence.

The company has a commercial arrangement, which would have applied if the technology had been recommended.