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Abbvie (ABBV) Imbruvica Approved in Lymphoma Indication
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AbbVie Inc. (ABBV - Free Report) announced that the FDA has approved its blood cancer drug, Imbruvica, for the treatment of patients with relapsed/refractory (R/R) marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy. The company had submitted a supplemental New Drug Application (sNDA) for Imbruvica in Sep 2016. The application was reviewed under accelerated approval by the FDA. However, continued approval will be based on data from a confirmatory trial.
Imbruvica is currently approved in the U.S. for the treatment of patients with mantle cell lymphoma or chronic lymphocytic leukemia (CLL) who have received at least one prior therapy and for CLL patients with deletion 17p. It is also approved for the treatment of Waldenstrom's macroglobulinemia.
Shares of AbbVie have outperformed the Zacks classified Large Cap Pharma industry in the last three months. The stock has gained 0.7% during the period, while the broader industry witnessed a drop of 1%.
Imbruvica was added to AbbVie’s pipeline through the May 2015 acquisition of Pharmacyclics. AbbVie markets Imbruvica under a partnership with Johnson & Johnson’s (JNJ - Free Report) subsidiary, Janssen Biotech, Inc.
The label expansion was based on data from a multi-center, open-label phase II PCYC-1121-CA trial evaluating Imbruvica as a single-agent treatment for MZL. The study enrolled 63 previously treated MZL patients. Patients received once-daily oral administration of Imbruvica. The primary endpoint of overall response rate as assessed by an Independent Review Committee was met.
We note that Imbruvica has one of the most robust clinical oncology development programs in the industry with nearly 30 company-sponsored trials underway, 14 of which are in phase III. The drug is approved for a number of indications and has multi-billion dollar potential. Moreover, AbbVie is exploring the potential of expanding Imbruvica’s label to include solid tumors and autoimmune diseases.
A registrational study for graft-versus-host disease is underway, with data expected shortly. Another 100 investigator-sponsored trials and external collaborations for Imbruvica are ongoing around the world.
AbbVie currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector include Enzo Biochem, Inc. (ENZ - Free Report) and ARIAD Pharmaceuticals, Inc . Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Enzo Biochem’s loss estimates narrowed from 17 cents to 16 cents for 2016 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 22.50%.
ARIAD’s loss estimates narrowed from 4 cents to 3 cents for 2016 and from 45 cents to 35 cents for 2017 over the last 30 days. The company posted a positive surprise in three of the four trailing quarters with an average beat of 171.37%.
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Abbvie (ABBV) Imbruvica Approved in Lymphoma Indication
AbbVie Inc. (ABBV - Free Report) announced that the FDA has approved its blood cancer drug, Imbruvica, for the treatment of patients with relapsed/refractory (R/R) marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy. The company had submitted a supplemental New Drug Application (sNDA) for Imbruvica in Sep 2016. The application was reviewed under accelerated approval by the FDA. However, continued approval will be based on data from a confirmatory trial.
Imbruvica is currently approved in the U.S. for the treatment of patients with mantle cell lymphoma or chronic lymphocytic leukemia (CLL) who have received at least one prior therapy and for CLL patients with deletion 17p. It is also approved for the treatment of Waldenstrom's macroglobulinemia.
Shares of AbbVie have outperformed the Zacks classified Large Cap Pharma industry in the last three months. The stock has gained 0.7% during the period, while the broader industry witnessed a drop of 1%.
Imbruvica was added to AbbVie’s pipeline through the May 2015 acquisition of Pharmacyclics. AbbVie markets Imbruvica under a partnership with Johnson & Johnson’s (JNJ - Free Report) subsidiary, Janssen Biotech, Inc.
The label expansion was based on data from a multi-center, open-label phase II PCYC-1121-CA trial evaluating Imbruvica as a single-agent treatment for MZL. The study enrolled 63 previously treated MZL patients. Patients received once-daily oral administration of Imbruvica. The primary endpoint of overall response rate as assessed by an Independent Review Committee was met.
We note that Imbruvica has one of the most robust clinical oncology development programs in the industry with nearly 30 company-sponsored trials underway, 14 of which are in phase III. The drug is approved for a number of indications and has multi-billion dollar potential. Moreover, AbbVie is exploring the potential of expanding Imbruvica’s label to include solid tumors and autoimmune diseases.
A registrational study for graft-versus-host disease is underway, with data expected shortly. Another 100 investigator-sponsored trials and external collaborations for Imbruvica are ongoing around the world.
AbbVie Inc. Price
AbbVie Inc. Price | AbbVie Inc. Quote
Zacks Rank & Key Picks
AbbVie currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector include Enzo Biochem, Inc. (ENZ - Free Report) and ARIAD Pharmaceuticals, Inc . Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Enzo Biochem’s loss estimates narrowed from 17 cents to 16 cents for 2016 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 22.50%.
ARIAD’s loss estimates narrowed from 4 cents to 3 cents for 2016 and from 45 cents to 35 cents for 2017 over the last 30 days. The company posted a positive surprise in three of the four trailing quarters with an average beat of 171.37%.
The Best Place to Start Your Stock Search
Today, you are invited to download the full list of 220 Zacks Rank #1 "Strong Buy" stocks – absolutely free of charge. Since 1988, Zacks Rank #1 stocks have nearly tripled the market, with average gains of +26% per year. Plus, you can access the list of portfolio-killing Zacks Rank #5 "Strong Sells" and other private research. See these stocks free >>