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AbbVie Gets FDA Approval for Lymphoma Drug


- By Alberto Abaterusso

AbbVie Inc. (ABBV) announced on Jan. 19 that its drug IMBRUVICA (ibrutinib) received the approval from the FDA as a therapy for patients affected with marginal zone lymphoma (MZL).

These patients need a treatment which active ingredient must reach and influence the highest possible number of cells of the human body through the bloodstream, and have received one or more prior therapies in the past including at least one "anti-CD20-based therapy," the company said.

Marginal zone lymphoma belongs to the family of slow-growing non-Hodgkin's lymphomas (NHL). These forms of NHL have some clinical characteristics. They generally occur outside the lymph nodes and involve the mucosa-associated lymphoid tissue of some organs, such as the stomach, the ocular adnexal (eyelid, orbital tissues), gut, salivary glands, bronchial tubes, skin and thyroid. They are called mucosa-associated lymphomas or MALT.

There are, however, still more rare forms called nodal marginal zone lymphomas, or Nodal MZL, that involve the lymph nodes and the spleen directly.

The company says that "MZL accounts for approximately 12 percent of all cases of non-Hodgkin's lymphoma in adults."

The FDA approval of AbbVie's Imbruvica for the treatment of the patients is based on the findings of a previous research, called the Phase 2 PCYC-1121 study, that involved 63 patients affected with marginal zone lymphoma and that showed a general response rate of 46% in terms of the therapy's efficacy.

The general response rate of 46% is in the range between 33.4% and 59.1% according to a confidence level of 95%.

In particular, the therapy based on Imbruvica was effective on 15 patients with MALT, on seven patients out a total of 17 with nodal MZL and on seven patients out of a total of 14 with splenic MZL. Two patients completely responded to the treatment and 27 responded to the treatment only partially.

AbbVie says that "the median time to the initial response was 4.5 months" among those treated.

The most recurrent adverse events ranged from grade 3 (severe) to grade 4 (life-threatening) and were observed in 67% of the participants. Anaemia, pneumonia and fatigue were the adverse events that recurred the most.

Imbruvica is a BTK inhibitor. BTK stands for Bruton's tyrosine kinase and is an enzyme that plays an important role in the development of the B cells, which are lymphocytes, a class of white blood cells.

On Jan. 20, AbbVie closed at $61.15, down 23 cents from the previous trading day, with a volume of 6,730,041 shares traded on the New York Stock Exchange.

AbbVie has a market capitalization of $99.37 billion and approximately 1.63 billion shares outstanding, of which 1.62 billion is float.

The percentage of the company's total number of shares outstanding held by insiders is 0.10% and held by institutions is 73.60%.

According to current market prices, AbbVie is trading at 15.36 times its book value per share and 11.55 times its Ebitda.

The recommendation rating is 2.5 and stands between a buy (2.0) and hold (3.0) recommendation.

The analysts' average target price is $69.94, which represents a 14.4% upside from last Friday's close.

During the fourth quarter of 2016, Ken Fisher (Trades, Portfolio) increased his position by 1.83% in AbbVie. He currently holds 696,569 shares of AbbVie.

Disclosure: I have no positions in AbbVie.

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This article first appeared on GuruFocus.