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J&J Files sBLA for Darzalex in Expanded Myeloma 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 its  proteasome inhibitor, Velcade (bortezomib), thalidomide and dexamethasone (VTd)) in patients with newly-diagnosed multiple myeloma (“MM”) who are eligible for autologous stem cell transplant (ASCT). The filing was based on data from a phase III CASSIOPEIA study.

Please note that Darzalex is already approved for use in combination with Velcade, melphalan and prednisone (VMP) for newly-diagnosed MM patients who are ineligible for ASCT. The FDA approval for the transplant ineligible patient population was received in May last year. This is the first filing for a Darzalex combination treatment regimen in the frontline setting for transplant eligible MM patients.

Earlier this month, J&J had filed a sBLA looking for approval of Darzalex in combination with the standard of care treatment regimen — Celgene’s CELG Revlimid (lenalidomide) and dexamethasone (Rd) in newly-diagnosed MM patients who are ineligible for ASCT. This sBLA filing was based on data from a phase III MAIA study.

J&J’s stock has risen 7.4% this year so far compared with an increase of 3.7% recorded by the industry.



Darzalex is approved as a monotherapy treatment for MM patients who have received at least three prior lines of therapy as well as in combination treatment with other MM drugs like Revlimid, Pomalyst and Velcade in different treatment settings.

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’s BMY Opdivo, and Amgen’s Kyprolis.

J&J currently has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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