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Darzalex powers ahead with frontline myeloma approval in Europe

New approval makes Darzalex first antibody drug approved in first line

Johnson & Johnson’s Darzalex is to take a more central role in multiple myeloma treatment following its European approval in a new frontline combination.

Its pharma division Janssen has gained EU approval for its use alongside Takeda’s Velcade (bortezomib), melphalan and prednisone (VMP) for newly-diagnosed myeloma patients who are ineligible for high-dose chemotherapy and autologous stem cell transplant (ASCT), a key front-line treatment strategy.

The approval is based on the results of the ALCYONE clinical trial, which shows that adding Darzalex to VMP cuts the risk of disease progression or death by 50% in these patients.

The EU approval follows a nod from the FDA in May, and this frontline use will add extra impetus to the drug, which is already enjoying rapid growth.  Sales nearly doubled in the second quarter compared to the same period last year, up to $511m in the second quarter ($298m in the US and $213m in the rest of the world).

First-line use will be the next growth driver for the intravenous anti-CD38 monoclonal antibody, initially based on the comparison with VMP, which showed the new drug reduced the risk of disease progression or death by 50%. The median progression free survival (PFS) for daratumumab-VMP had not yet been reached, compared to an estimated median PFS of 18.1 months for patients who received VMP alone.

“Today’s approval is extremely important for multiple myeloma patients, as providing a frontline treatment option that demonstrates a deep and durable response often provides the best chance at lasting remission. It’s all the more remarkable considering it has only been ten years since the first dose of daratumumab was administered in the earliest human studies,” said Dr Torben Plesner, the first investigator to administer daratumumab in human trials and Professor, head of the department of hematology at Vejle Hospital, Denmark. “I am proud that patients across Europe now have the option to use a monoclonal antibody as an initial therapy.”

Dr Catherine Taylor

Janssen's Dr Catherine Taylor

Dr Catherine Taylor, Europe, Middle East and Africa (EMEA) Haematology Therapeutic Area Lead, Janssen. “Our mission has been to ensure daratumumab reaches as many eligible patients as possible and to prolong and improve their quality of life. This is a significant step forward.”

J&J has even more in the pipeline: it's investigating Darzalex as an add-on to regimens based on Celgene’s myeloma blockbuster Revlimid (lenalidomide) and in ASCT-eligible patients could further expand the opportunity in previously-untreated patients.

The biologic is also in trials in an even earlier setting, in patients with so-called ‘smouldering’ multiple myeloma, a precursor to full-blown disease that can be diagnosed by measuring biomarkers in blood and urine.

Meanwhile there are four ongoing phase III trials of a new patient-friendly subcutaneous formulation that should be ready for filing before 2021.

A rival biologic in multiple myeloma is BMS and AbbVie’s Empliciti (elotuzumab), though this is trailing far behind Darzalex in sales, earning a more modest $64m in Q2.

Article by
Andrew McConaghie

3rd September 2018

From: Marketing



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