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J&J gets FDA green light for myeloma drug Darzalex

First-in-classtargeted immunotherapy wins US approval

Johnson & Johnson (J&J)

Johnson & Johnson's Darzalex, a first-in-class targeted immunotherapy for multiple myeloma, has been approved by the US FDA.

Darzalex (daratumumab) is the first human anti-CD38 monoclonal antibody to be cleared anywhere in the world and will be sold by J&J's Janssen Biotech unit for multiple myeloma patients whose cancer has become resistant to other treatments.

The approval comes well ahead of schedule as the FDA's action date for the review was not until March 9 next year, and reflects the importance of the new drug for patients who have run out of other treatment options.

The antibody has been provisionally approved on the basis of response rate data in a phase II, single-arm clinical trial, and J&J will have to show in confirmatory studies that this is matched by a clinical benefit. 

In the trial - called SIRIUS - daratumumab achieved a 65% one-year overall survival rate and nearly 30% objective response rate in patients with 'double refractory' multiple myeloma.

It has also been filed for approval in Europe, where it has been granted an accelerated assessment, as well as in Canada.

Specifically, Darzalex has been approved in patients who have received at least three prior lines of treatment, including a proteasome inhibitor such as Takeda's Velcade (bortezomib) and an immunomodulatory agent like Celgene's Revlimid (lenalidomide).

"Multiple myeloma is a highly complex disease and remains incurable, with almost all patients relapsing or becoming resistant to therapy," said Paul Richardson of the Dana-Farber Cancer Institute in the US, the lead investigator in the Darzalex clinical trial.

J&J's antibody is "a promising new immunotherapy, which has shown pronounced efficacy as a single agent with an acceptable adverse event profile", he added.

The drug costs around $135,500 for the first year's treatment, according to J&J, falling to around $76,000 in year two as the number of doses reduces. Darzalex is initially dosed once a week for two months, with this loading phase followed by maintenance treatment with monthly infusions.

Approval of daratumumab triggers a $45m payment from Janssen to Denmark's Genmab, which originally discovered the drug and licensed it to J&J in a $1.1bn deal

Genmab noted that Darzalex is also in the phase III CASTOR study looking at its use in combination with Velcade and dexamethasone in patients with relapsed or refractory multiple myeloma, as well as the POLLUX trial which pairs the antibody with Cegene's Revlimid. 

J&J and Genmab are also working on a subcutaneous formulation of daratumumab which has just started clinical testing.

Darzalex is just one of a number of new therapies entering the market for multiple myeloma, with others including Takeda's ixazomib and Novartis' recently-approved HDAC inhibitor Farydak (panobinostat). 

Its approval comes ahead of another medicine deemed a breakthrough by the FDA - Bristol-Myers Squibb and AbbVie's SLAMF7-targeting antibody elotuzumab - which was granted a priority review in September.

Article by
Phil Taylor

17th November 2015

From: Sales



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