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AbbVie Gets FDA Nod for Imbruvica+Rituxan in First-Line CLL

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Zacks Equity Research
·3 min read
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AbbVie ABBV and J&J JNJ announced that the FDA has approved a label expansion of their key blood cancer drug, Imbruvica (ibrutinib) in combination with Roche RHHBY/Biogen’s BIIB multi-disease drug, Rituxan (rituximab). The drug, in combination with Rituxan, is now approved for the first-line treatment of adult patients (70 years or younger) with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

This is the 11th FDA approval for Imbruvica and sixth in CLL, the most common form of leukemia in adults.

AbbVie and J&J had filed a supplemental new drug application seeking label expansion of Imbruvica based on positive data from the phase III E1912 study. Data from the study showed that treatment with the Imbruvica combination regimen significantly improved progression-free survival and overall survival in the above patients compared to the FCR chemoimmunotherapy regimen, the gold-standard for first-line treatment of CLL.

Please note that Imbruvica is already approved as monotherapy for previously untreated CLL/SLL patients. The drug was also approved for first-line treatment of CLL/SLL patients in combination with Roche’s another drug, Gazyva last year.

AbbVie’s shares have declined 9.3% so far this year compared with the industry’s decrease of 1.2%.

Imbruvica is a key drug in AbbVie’s oncology franchise along with Venclexta. Oncology has become a key therapeutic area for AbbVie and the company believes that it will be its major driver over the next 10 years. The company expects double-digit growth for its oncology franchise sales in 2020.

Meanwhile, several studies on Imbruvica are underway to evaluate the drug alone or in combination across different patient segments, including cancer as well as autoimmune diseases. AbbVie is also studying Venclexta to expand its label to address a broader relapsed/refractory CLL patient population, extend into earlier lines of therapy and cover other hematologic malignancies like multiple myeloma and acute myeloid leukemia.

Growth in sales of these drugs will also offset declining international sales of AbbVie’s major revenue generator, Humira, to an extent. The anti-inflammatory drug is already facing generic competition in European markets, which dented its international sales. It is set to face generic competition in U.S. markets beginning 2023.

However, we note that in a bid to diversify its portfolio AbbVie announced an acquisition offer approximately worth $63 billion for Allergan in June 2019 to add blockbuster drug, Botox, to its portfolio, which it expects to help offset decline in Humira sales. We expect an update related to the closing of the transaction on the company’s first-quarter earnings call, which is due on May 1.

AbbVie Inc. Price


AbbVie Inc. Price
AbbVie Inc. Price

AbbVie Inc. price | AbbVie Inc. Quote

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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