J&J Files Application for Darzalex Label Expansion in Europe

Zacks Equity Research

Johnson & Johnson JNJ announced that it has filed a type II variation application to the European Medicines Agency (EMA), seeking an approval for the label expansion of Darzalex (daratumumab) as a combination therapy for an expanded patient population.

J&J is looking for a nod with respect to Darzalex in combination with Celgene’s CELG Revlimid (lenalidomide) and dexamethasone (Rd) for treating the newly-diagnosed multiple myeloma (MM) patients, who are ineligible for autologous stem cell transplant (ASCT). The filing was based on data from a phase III MAIA study.

Results from the program showed that at a median follow-up of 28 months, Darzalex plus Rd significantly reduced the risk of disease progression or death by 44% in such patients compared with patients treated with Rd alone. Though the median progression free survival (PFS) for Darzalex plus Rd arm was not reached, the PFS was 31.9 months for patients, who received only Rd.

In Europe, Darzalex is already approved for use in combination with bortezomib, melphalan and prednisone (VMP) for the newly-diagnosed MM in adult patients, who are ineligible for ASCT.


Shares of J&J have risen 6.1% so far this year, outperforming the industry’s increase of 3.7%.

Earlier in March, J&J filed a supplemental biologics license application (sBLA) with the FDA to get an approval for Darzalex for the same patient population in the given combo regimen. The investigation is being reviewed by the FDA under the Real-Time Oncology Review (RTOR) pilot program, which ensures a more efficient assessment process.

In February 2019, J&J announced that the FDA granted an approval to a split-dosing regimen of Darzalex. With this nod, Darzalex’s label is updated in the United States to allow prescribing the medicine by splitting the first infusion of Darzalex over two consecutive days. Approval for this split dosing option is likely to improve the administration profile of the medicine.

Notably, Darzalex generated sales of $2.03 billion in 2018, representing a surge of more than 63% year over year. The drug remains a key contributor to J&J’s top line.

Meanwhile, Darzalex is being evaluated in a comprehensive clinical development program across a range of treatment settings in MM, such as in frontline and relapsed settings. These include combination studies with other cancer drugs like Roche’s RHHBY atezolizumab, Bristol-Myers’ BMY Opdivo, and Amgen’s Kyprolis.

Zacks Rank

J&J currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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