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J&J Immunotherapy Darzalex Ok’d for Expanded Combination Use


Johnson & Johnson JNJ announced that its immunotherapy, Darzalex has been approved for use in combination with Celgene Corporation’s CELG multiple myeloma drug Pomalyst (pomalidomide) and dexamethasone. The combination has been approved for the treatment of patients with multiple myeloma who have received at least two prior therapies including Revlimid (an immunomodulatory agent) and a proteasome inhibitor (PI).

The approval was based on data from the phase Ib EQUULEUS study, which showed an overall response rate (ORR) of 59.2% with Darzalex in combination with Pomalyst and dexamethasone in the abovementioned patients.

Darzalex is already approved in the U.S. as well as EU for use in combination with Revlimid and dexamethasone, or Velcade (a proteasome inhibitor/PI) and dexamethasone, for the treatment of adult patients with relapsed multiple myeloma patients who have received at least one prior therapy. Darzalex was approved in Nov 2015 as a monotherapy for multiple myeloma in patients who had received at least three prior lines of therapy, including PI and an immunomodulatory agent.

J&J’s shares have outperformed the Zacks classified Large Cap Pharma industry so far this year. The company’s shares have gained 16.6% compared with the industry’s gain of 11.4%.

Coming back to Darzalex, the drug has been generating strong sales and is a key contributor to J&J’s top line. It is enjoying strong adoption in outside U.S. markets following launches last year as well as accelerated adoption in the U.S.

Darzalex is also being evaluated in a comprehensive clinical development program that includes five phase III studies 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 carries 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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