NICE meets Janssen halfway over Darzalex

pharmafile | January 18, 2018 | News story | Medical Communications, Sales and Marketing J&J, JJ, Janssen, biotech, darzalex, drugs, pharma, pharmaceutical 

NICE rejected Janssen’s Darzalex (Daratumumab) back in March last year, concluding that it wasn’t able to accurately determine the efficacy of the drug based on data submitted and therefore couldn’t reach a decision on cost-effectiveness.

Nearly one year later and a further appraisal on, NICE has reached the conclusion that it isn’t adequately able to determine the efficacy of the drug.

It will be some comfort to the company that NICE recommended that the drug be made available through the Cancer Drug Fund while it further evaluates the treatment.

Janssen was pushing for an approval of the treatment of multiple myeloma on a fourth-line basis, the indication it holds in the US, but will have to settle for the half-way house of CDF funding. Any hopes to have the treatment rolled out as standard fourth-line treatment will have to wait until the end of 2020.

The list price for the treatment indicates that for an average of 3.4 months of treatment, the cost of the treatment would be £74,531 per patient, including administrations fees.

Despite the difficulty Janssen is having getting the drug through to patients, Myeloma UK Chief Executive, Rosemarie Finley remained upbeat on the news: “This is really heartening news for myeloma patients and their families. Daratumumab is an exciting and innovative new treatment which has been shown to have a very beneficial effect on length of remission in patients who respond. This is an important new treatment option for patients whose myeloma has come back and who may have exhausted other treatment options, or who are not responding well to other types of myeloma treatments.”

The results of the trial data submitted to NICE showed that the treatment offered a “relative short median progression-free survival” rate of 3.7 months in one study and 6.2 months in another. However, NICE was more upbeat on the overall survival that reached 18.6 months in one study.

Ben Hargreaves

Related Content


Janssen submits sNDA to FDA for full approval of Balversa

The Janssen Pharmaceutical Companies of Johnson & Johnson has announced the submission of a supplemental …

FDA approves IMIDEX’s AI-powered device VisiRad XR

The technological pharmaceutical company IMIDEX has been granted clearance from the US Food and Drug …

Artiva Biotherapeutics announces FDA clearance of IND for AlloNK and Rituximab combo

On 16 August 2023, the US Food and Drug Administration (FDA) officially cleared Artiva Biotherapeutics’ …

Latest content