How are you taking part in this consultation?

You will not be able to change how you comment later.

You must be signed in to answer questions

  • Question on Document

    Has all of the relevant evidence been taken into account?

  • Question on Document

    Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?

  • Question on Document

    Are the recommendations sound and a suitable basis for guidance to the NHS?

  • Question on Document

    Are there any aspects of the recommendations that need particular consideration to ensure we avoid unlawful discrimination against any group of people on the grounds of race, gender, disability, religion or belief, sexual orientation, age, gender reassignment, pregnancy and maternity?
The content on this page is not current guidance and is only for the purposes of the consultation process.

Dacomitinib for untreated EGFR mutation-positive non-small-cell lung cancer

Closed for comments This consultation ended on at   Request commenting lead permission

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.