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NICE partially clears Darzalex combo in blood cancer

Approved in second-line use under  CDF


NICE has recommended Janssen’s Darzalex in combination with Takeda’s Velcade as a second-line treatment for multiple myeloma via the cancer drugs fund (CDF).

The cost-effectiveness watchdog cited lack of long-term evidence as the reason why the regimen failed to achieve routine use status, but if Janssen can deliver the data within the next two years, it could gain a full NICE recommendation.

“Some of the cost effectiveness evidence we reviewed suggests daratumumab could notably increase the overall survival of people who have had one previous therapy, but the long-term trial data is limited,” said Meindert Boysen, director of NICE’s Centre for Health Technology Evaluation.

Imbalances in the type of previous treatments used in the trial arms also added to the data concerns. Notably, 29% of those in one trial arm used Celgene’s Revlimid as their first-line treatment; where as only 12% in the other group used Darzalex.

“This imbalance could have favoured [the Darzalex combo] because patients in this trial arm may have had a better prognosis,” said the CDF clinical lead.

Clinical experts stated that there was no evidence to suggest that Revlimid modifies the effect of subsequent treatments, but the committee said it had seen no evidence to support this claim.

Despite the limited data, the committee said the treatment was a potential “game-changer” for those with relapsed multiple myeloma after it evaluated the drug’s efficacy.

When used in combination with Velcade and corticosteroid medication dexamethasone, those taking Darzalex achieved an extended progression free survival of 18 months compared to existing therapies.

Boysen added: “We have approved daratumumab for use in the Cancer Drugs Fund so people at this stage of their disease can access the treatment while more data is collected.”

It’s a familiar decision for Janssen, which last year failed to win over NICE for Darzalex to be used as a third-line treatment in those with multiple myeloma.

Nevertheless, it is estimated that 2,900 people in England will be eligible for the Darzalex combination each year  through the CDF.

Darzalex is a monoclonal antibody treatment that identifies and attacks multiple myeloma cells by recognising the CD38 protein that’s commonly expressed in this type of cancer.

The drug is one of Janssen's rising stars, generating more than $2bn in revenues last year, a rise of 63% from 2017, chiefly due to its good  toxicity profile and efficacy when used alone or in combination with other drugs.

Myeloma is an increasingly dynamic and competitive therapy class, with new agents such as BCMA-targeting CAR-T therapies in the late-stage pipeline.

Darzalex could face some direct competition from Sanofi's challenger isatuximab, which recently registered some impressive results in phase 3 trials.

Article by
Gemma Jones

13th March 2019

From: Regulatory



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