Dabrafenib has been recommended by NICE for adults with advanced non-small-cell lung cancer with a BRAF V600 mutation, with the regulator saying that hundreds are set to benefit. People with advanced non-small-cell lung cancer (NSCLC) generally have a poor prognosis, a spokesperson for the National Institute for Health and Care Excellence (NICE) said.
The symptoms can be hard to treat and distressing for the person with the condition and for their family members, the spokesperson stressed.
Despite targeted treatments being available for NSCLC that have other specific driver mutations, there were currently no NICE-recommended options specifically for NSCLC that was positive for a BRAF V600 mutation.
NICE explained in its final draft guidance, that the BRAF mutation was present in around 1-3% of lung cancers. Around half of all BRAF mutations were V600 mutations, and most BRAF V600 mutations were V600E mutations, the regulator said.
"BRAF V600 mutations are commonly found in older people and in people with a history of smoking," NICE pointed out. However, chemotherapy and immunotherapy may not be tolerated in this group of people, the regulator alerted. Moreover, it pointed out that existing treatment options were associated with substantial healthcare resource use, and many chemotherapy day units had long waiting times.
BRAF V600 mutation-positive advanced NSCLC had a "substantial effect" on quality of life, and there was an unmet need for a new treatment option, explained NICE.
Hundreds to Benefit
In the guidance NICE recommended dabrafenib (Tafinlar, Novartis) with trametinib (Mekinist, Novartis) as an option for treating BRAF V600 mutation-positive advanced NSCLC in adults, if it is used as first-line treatment of advanced stage cancer, and so long as the company provides it according to the commercial arrangement.
A clinical trial had suggested the drug combination shrunk tumours and increased how long people lived before their condition became worse. In the trial, for those who had had no anticancer therapies for metastatic disease, NICE said the overall response rate was 64%, comprising a complete response rate (cancer not detectable) of 6%, and a partial response rate (cancer had shrunk by 30% and not spread) of 58%. The median progression-free survival was 11 months (7-15 months), and the median overall survival was 17 months (12-40 months).
However, NICE underlined that the results were uncertain because of the small number of people in the trial.
NICE estimated that around 300 people could be eligible to receive the treatment, and reassured those already receiving this treatment outside of the new recommendations that they "may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop".
Dabrafenib with trametinib is given as capsules taken twice a day. Dabrafenib costs £1,400 per 28-pack of 75-mg capsules, and trametinib costs £4,800 per 30-pack of 2-mg tablets (excluding VAT). The company has separate commercial arrangements for dabrafenib and trametinib, and makes dabrafenib and trametinib available to the NHS with confidential discounts.