AbbVie's Imbruvica Combo Gets FDA Nod In First-Line Setting

AbbVie (NYSE:ABBV) and J&J (NYSE:JNJ) announced that the FDA has approved a label expansion of their key cancer drug, Imbruvica (ibrutinib) in combination with Roche’s (OTC:RHHBY) Gazyva (obinutuzumab). The drug, in combination with gazyva, is now approved for first-line treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

With the FDA approval, Imbruvica plus obinutuzumab becomes the first chemotherapy-free CD20 combination in first-line CLL treatment.

Imbruvica is now approved in 10 different settings in six cancer indications. Imbruvica is already approved as monotherapy or in combination with Teva’s (NYSE:TEVA) Treanda (bendamustine) and Biogen/Roche’s Rituxan (rituximab) for CLL/SLL.

AbbVie’s shares have declined 15.7% in the past six months compared with the industry’s decrease of 1%.

The approval was based on data from the phase III study – iLLUMINATE – evaluating the Imbruvica combination therapy in previously untreated CLL/SLL patients 65 years or older or in patients below 65 years with coexisting conditions. Data from the study showed that the combination significantly improved progression-free survival (PFS) (77%) compared to chlorambucil plus Gazyva. The combination also reduced risk of progression or death by 85% in patients with high-risk disease.

The chlorambucil plus Gazyva therapy is the National Comprehensive Cancer Network ("NCCN") recommended treatment for CLL/SLL patients.

The FDA also approved an update to Imbruvica’s label to include additional long-term efficacy data from phase III studies, RESONATE and RESONATE-2, evaluating the drug as monotherapy in CLL/SLL patients.

Imbruvica, a key drug in AbbVie’s oncology portfolio, generated $3.6 billion in sales in 2018, growing almost 40% compared to 2017. Sales of another important cancer drug in AbbVie’s oncology portfolio, Venclexta more than doubled to $344 million in 2018.

However, AbbVie’s major revenue generator, Humira, started to face biosimilar competition in European markets during the fourth quarter of 2018, which resulted in international revenue, decline of 17.5% on a reported basis. The unfavorable impact is likely to increase in the future quarters. Although Humira is protected in the United States till 2023, a biosimilar launch following that will have significant unfavorable impact on the company’s top line.

AbbVie’s focus on developing its oncology portfolio along with the HCV treatment, Mavyret, and a few other new drugs is encouraging as growth in the sales of these drugs will partially offset the decline in Humira sales.

Zacks Rank

AbbVie currently 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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