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J&J Seeks Approval for Darzalex in Expanded Patient Group

Zacks Equity Research

Johnson & Johnson JNJ filed a supplemental biologics license application (sBLA) with the FDA to get approval for Darzalex combination therapy for an expanded patient population.

With the sBLA filing, J&J is looking for approval of Darzalex in combination with the standard of care treatment regimen — Celgene’s CELG Revlimid (lenalidomide) and dexamethasone (Rd) — in patients with newly-diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The filing was based on data from a phase III MAIA study.

Please note that Darzalex is already approved for use in combination with Takeda’s Velcade, melphalan and prednisone (VMP) for newly-diagnosed multiple myeloma in patients who are ineligible for ASCT. The FDA approval for this patient population was received in May last year.

Previous data from the MAIA study showed that at a median follow-up of 28 months, the addition of Darzalex to Rd significantly reduced the risk of disease progression or death by 44% in such patients compared to treatment with Rd alone. While progression free survival (PFS) for patients who received Rd alone was 31.9 months, the median PFS for Darzalex plus Rd arm was not reached. The study is being reviewed by the FDA under the Real-Time Oncology Review (RTOR) pilot program, which ensures a more efficient review process.

J&J’s stock has risen 6.9% this year so far compared with an increase of 3.5% recorded by the industry.



Darzalex has been generating strong sales and is a key contributor to J&J’s top line. The drug generated sales of $2.03 billion in 2018, representing year-over-year growth of more than 63%.

Meanwhile, Darzalex is being evaluated in a comprehensive clinical development program across a range of treatment settings in multiple myeloma, such as in frontline and relapsed settings.

These include combination studies with other cancer drugs like Roche Holding AG’s RHHBY atezolizumab, Bristol-Myers Squibb Company BMY Opdivo, and Amgen’s Kyprolis.

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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