AbbVie Eyes Approval for Imbruvica+Rituxan in First-Line CLL

AbbVie Inc. ABBV and J&J JNJ announced that they have submitted a supplemental new drug application (sNDA) seeking label expansion of their blood cancer drug, Imbruvica. The sNDA is seeking approval of Imbruvica in combination with Roche RHHBY/Biogen’s BIIB monoclonal antibody, Rituxan (Rituximab), as a first-line treatment of patients with chronic lymphocytic leukemia (“CLL”) or small lymphocytic lymphoma (“SLL”), who are 70 years old or younger.

The sNDA wasbased on positive data from the phase III E1912 study, which 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 regulatory application is being reviewed by the FDA under its Real-Time Oncology Review pilot program, which allows the regulatory body to initiate review clinical data before complete submission of any regulatory application. This is likely to expedite the review process for this sNDA. If approved for the combination use, it will be the 11th FDA approval for Imbruvica across six distinct disease areas

A combination regimen of Imbruvica, Rituxan and Teva Pharmaceutical’s Treanda (bendamustine) is already approved for previously treated CLL/SLL patients. Moreover, Imbruvica is approved in previously untreated CLL/SLL patients as monotherapy and in combination with Roche’s Gazyva. The FDA granted an approval for the Imbruvica-Gazyva combo in January 2019.

AbbVie’s shares have declined 7.6% so far this year against the industry’s increase of 3.6%.

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. 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 Venclyxto/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.

In July, AbbVie acquired Seattle-based, privately held company Mavupharma to develop novel treatments for cancer using the latter’s STING signaling pathway and enhance its early-stage oncology pipeline.

Moreover, in a bid to diversify its portfolio AbbVie announced an acquisition offer approximately worth $63 billion for Botox-maker Allergan in June. The company remains on track to complete the acquisition in the first quarter of 2020.

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AbbVie currently carries a Zacks Rank #3 (Hold).

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