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Johnson & Johnson and AbbVie Earn a New FDA Approval for Imbruvica

By Prosper Junior Bakiny - Apr 22, 2020 at 1:48PM

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The cancer drug is now approved for 11 different indications.

Imbruvica, a blockbuster cancer drug marketed by Johnson & Johnson (JNJ 0.48%) and AbbVie (ABBV -0.22%), recently secured its 11th approval. On Tuesday, the Food and Drug Administration approved the combination of Imbruvica and Rituximab as a treatment for patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL); Rituximab is a cancer drug marketed by Biogen (BIIB 0.63%)

This approval was based on positive results from a phase 3 clinical trial. During the trial, CLL patients under age 70 who were treated with a combination of Imbruvica and Rituximab achieved a progression-free survival (PFS) rate -- the amount of time during and after treatment the patient lives with cancer without experiencing worsening symptoms -- of 88% after 37 months. By contrast, patients on chemotherapy drugs and Rituximab achieved a PFS rate of 75%.

Doctor standing in a pharmacy.

Image Source: Getty Images.

Johnson & Johnson originally co-developed Imbruvica with Pharmacyclics, an oncology-focused biotech company that was acquired by AbbVie back in 2015 in a cash and stock transaction valued at $21 billion. Johnson & Johnson and AbbVie equally share the profits (and losses) from the sale of Imbruvica.

With sales of Humira -- by far AbbVie's biggest moneymaker -- losing steam in Europe due to competition from biosimilars, the pharma giant has high hopes for Imbruvica. As CEO Richard A. Gonzalez said: "Imbruvica remains the clear market-share leader across all lines of therapy in CLL. With the largest body of clinical evidence, a robust survival benefit, and the highest category rating in treatment guidelines today, we remain confident that Imbruvica will be a significant growth contributor for many years to come."

During its latest reported quarter -- Q4 2019 -- AbbVie reported net revenue of $1.3 billion from Inbruvica, representing a 28.9% year-over-year increase.

Prosper Junior Bakiny has no position in any of the stocks mentioned. The Motley Fool owns shares of and recommends Biogen. The Motley Fool recommends Johnson & Johnson. The Motley Fool has a disclosure policy.

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Stocks Mentioned

Johnson & Johnson Stock Quote
Johnson & Johnson
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AbbVie Inc. Stock Quote
AbbVie Inc.
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