J&J's Darzalex Gets FDA Nod For First-Line Multiple Myeloma

Johnson & Johnson (NYSE:JNJ) announced that its subsidiary, Janssen, has received approval from the FDA for label expansion of its blockbuster drug, Darzalex.

The latest approval is for Darzalex in combination with Celgene’s (NASDAQ:CELG) Revlimid (lenalidomide) and dexamethasone (Rd) to treat newly diagnosed multiple myeloma (“MM”) patients ineligible for autologous stem cell transplant (“ASCT”).

A combination of Darzalex, Takeda’s (NYSE:TAK) Velcade (bortezomib), melphalan and prednisone is already approved for transplant ineligible MM patients in the first-line setting. The recent approval is Darzalex’s sixth FDA approved indication in multiple myeloma and the second for newly diagnosed patients.

In March, J&J filed a regulatory application seeking approval of a similar Darzalex combination for a similar indication in Europe. The company is also looking for approval of Darzalex in combination with Velcade, thalidomide and dexamethasone (VTd) in patients with newly-diagnosed MM who are eligible for ASCT.

J&J’s stock has risen 9% this year so far compared with an increase of 1.9% recorded by the industry.

The approval was based on data from the phase III MAIA study, which 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 regulatory application was reviewed by the FDA under the Real-Time Oncology Review pilot program, which ensures a more efficient review process.

Darzalex has been generating strong sales and is a key contributor to J&J’s top line. The drug generated sales of $629 million in the first quarter of 2019, representing year-over-year growth of nearly 45.5%.

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 (SIX:ROG) AG’s (OTC:RHHBY) Tecentriq, Bristol-Myers’ 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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