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Roche/AbbVie's Lymphocytic Leukemia Drug Gets FDA Nod

Roche Holding AG  RHHBY, along with its partner AbbVie Inc. ABBV, announced that the FDA has granted accelerated approval to Venclexta (venetoclax) for the treatment of patients suffering from previously treated chronic lymphocytic leukemia (CLL) with a 17p deletion.

Leukemia will need to be detected by an FDA-approved test. AbbVie will commercialize the drug outside the U.S., while both the countries will commercialize the drug in the U.S.

According to Roche, Venclexta is the first drug to be approved for restoring a process in which cells self-destruct (apoptosis) by selectively blocking the BCL-2 protein.

Accelerated approval allows a conditional approval of a drug that addresses an unmet medical need for a serious condition based on early evidence suggesting clinical benefit. However, continued approval in this indication is contingent upon the verification and description of the drug’s clinical benefit in confirmatory trials.

We remind investors that Venclexta was granted Breakthrough Therapy Designation by the FDA for the same indication. Roche’s Marketing Authorization Application (MAA) for the candidate is currently under review in the EU.   

Meanwhile, Venclexta is currently in phase III studies for the treatment of relapsed, refractory and previously untreated CLL. The candidate is also being evaluated for other types of blood cancers including indolent non-Hodgkin’s lymphoma, diffuse large B-cell lymphoma, acute myeloid leukemia and multiple myeloma.

The approval of Venclexta further strengthens Roche’s hematology portfolio, which already boasts drugs like MabThera/Rituxan (rituximab) and Gazyva. The company also has a deep pipeline comprising an anti-PDL1 antibody (atezolizumab/MPDL3280A), an anti-CD79b antibody drug conjugate (polatuzumab vedotin/RG7596) and a small-molecule antagonist of MDM2 (idasanutlin/RG7388).

Roche has a strong presence in the oncology market. In particular, the company dominates the breast cancer space with strong demand for its HER2 franchise, which includes drugs like Herceptin, Perjeta and Kadcyla.

Approval of new drugs for leukemia will further broaden its oncology portfolio and somewhat offset the loss of revenues resulting from the generic competition for Xeloda, Zelboraf and Pegasys.

Roche currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector include Novo Nordisk A/S NVO and Eli Lilly and Company LLY. Both the stocks carry a Zacks Rank #2 (Buy).

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ROCHE HLDG LTD (RHHBY): Free Stock Analysis Report
LILLY ELI & CO (LLY): Free Stock Analysis Report
NOVO-NORDISK AS (NVO): Free Stock Analysis Report
ABBVIE INC (ABBV): Free Stock Analysis Report
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