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Johnson & Johnson’s (JNJ - Free Report) subsidiary, Janssen, announced that the FDA has approved its immunotherapy Darzalex to be used in combination with standard-of-care – Velcade (a proteasome inhibitor/PI) and dexamethasone or Revlimid (an immmunomodulatory agent) and dexamethasone–  forthe treatment of patients with multiple myeloma who have received at least one prior therapy. The approval came three months after a supplemental Biologics License Application (sBLA) was submitted in August.

Data from clinical studies in the past have shown that Darzalex in combination with Velcade/dexamethasone reduced the risk of disease progression or death by 61% compared to Velcade/dexamethasone alone. On the other hand, compared to Revlimid/dexamethasone alone, Darzalex in combination with Revlimid/dexamethasone reduced the risk of disease progression or death by 63%

The FDA had granted breakthrough therapy designation to Darzalex for the combination use in July. Regulatory application for the indication is under review in the EU.

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Darzalex had gained accelerated FDA approval in Nov 2015. It was approved, as a monotherapy, for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent. It was also okayed for patients who are double-refractory to a PI and an immunomodulatory agent.

In May, Darzalex gained conditional approval in the EU for use as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunotherapy agent and who have demonstrated disease progression on the last therapy.

We remind investors that Janssen Biotech, Inc. had entered into a worldwide agreement with Genmab A/S (GNMSF - Free Report) in Aug 2012, whereby the former was granted an exclusive license to develop, manufacture and commercialize Darzalex.

Janssen also entered into a clinical trial collaboration agreement with Roche Holding AG’s (RHHBY - Free Report) Genentech in March, under which Darzalex’s safety and tolerability will be evaluated in combination with Genentech’s atezolizumab in a couple of early-stage studies. The deal will see Janssen sponsor an open-label, multi-center phase Ib study that will evaluate Darzalex in combination with atezolizumab in patients with solid tumor.

We note that Amgen Inc.’s (AMGN - Free Report) Kyprolis is also approved for the treatment of multiple myeloma.

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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