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JNJ’s Darzalex Scores FDA Nod For Multiple Myeloma Treatment
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JNJ’s Darzalex Scores FDA Nod For Multiple Myeloma Treatment

The U.S. Food and Drug Administration (FDA) has approved the use of Johnson & Johnson’s (JNJ) Darzalex (daratumumab) with carfilzomib and dexamethasone (DKd) to treat adults with relapsed/refractory multiple myeloma who have already received one to three lines of therapy.  

A supplemental Biologics License Application (sBLA) for this indication was submitted by Johnson & Johnson’s Janssen Biotech unit in February 2020. In August 2012, Genmab (GMAB) granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells. It is the third most common blood cancer in the U.S., after leukemia and lymphoma. 

“We are extremely pleased that multiple myeloma patients in the U.S. will now have yet another treatment option as this is the eighth overall U.S. FDA approval for Darzalex and the fifth in the relapsed/refractory setting. In addition, Darzalex is now the first CD38 antibody approved for use in combination with carfilzomib,” said Jan van de Winkel, CEO of Genmab.

The combination has been approved in two carfilzomib dosing regimens, 70 mg/m2 once weekly and 56 mg/m2 twice weekly, based on positive results from the Phase 3 and Phase 1b studies.

The Phase 3 trial was a randomized, open-label study that included 466 patients with multiple myeloma who had relapsed after 1 to 3 prior therapies. The primary endpoint of the study was progression free survival (PFS).

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. It triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death.

Additional studies are now planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis and T-cell acute lymphocytic leukemia.

Shares in JNJ are trading up 4% year-to-date, and analysts have a bullish Strong Buy consensus on the stock. That’s with 7 back-to-back buy ratings in the last three months. Meanwhile the $167 average analyst price target indicates 10% upside potential lies ahead.

Merrill Lynch analyst Bob Hopkins recently reiterated a Buy rating on the stock with a $175 price target, saying “JNJ’s Q2 call confirmed what most believed heading into Q2 – that JNJ’s vaccine is on track and that JNJ’s fundamentals remain very strong in an uncertain environment.”

“We rate JNJ Buy given that the stock trades at a discount to the S&P500 which seems a relative mispricing given JNJ’s strong relative outlook in this challenging time and JNJ should be able to deliver strong results through a pressured environment” the analyst told investors. (See JNJ stock analysis on TipRanks).

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