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Roche Gets FDA Nod for Venclexta Plus Gazyva to Treat CLL

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Roche Holding AG RHHBY announced that the FDA has approved its supplemental new drug application (sNDA) for Venclexta (venetoclax) in combination with Gazyva (obinutuzumab). The company is a seeking label expansion of the drug for the first-line treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

The nod was based on data from the phase III CLL14 study, which compared Venclexta + Gazyva with Gazyva + chlorambucil. Results from the program showed that Venclexta + Gazyva demonstrated a durable and significant reduction in the risk of disease worsening or death by 67% as compared to Gazyva + chlorambucil, a current standard-of-care.

Roche plans to present the study outcomes at the American Society of Clinical Oncology Annual Meeting to be held in June 2019.

Venclexta is co-developed by AbbVie ABBV and Genetech, a unit of Roche. Both Roche and AbbVie co-commercialize the product in the United States while the latter exclusively commercializes the same in ex-U.S. markets.


The FDA reviewed and approved the sNDA under its Real-Time Oncology Review (RTOR) and Assessment Aid pilot programs. Previously, the regulatory agency had granted Venclexta a Breakthrough Therapy Designation in combination with Gazyva for the treatment of previously untreated CLL with co-existing medical conditions.

Notably, last September, the FDA approved the label expansion of Venclexta in combination with Rituxan to include minimal residual disease (MRD)-negativity data from the phase III MURANO study.

The investigation evaluated the combo regimen for relapse/refractory CLL patients, having received at least one prior therapy as compared to Teva Pharmaceuticals’ TEVA Treanda (bendamustine) plus Rituxan.

These label expansions of the drug will help it gain an access to a broader patient population and should drive sales in the future.

Shares of Roche have increased 4.9% so far this year versus the industry’s decrease of 1.1%.

In a separate press release, Roche announced positive findings from the phase I/II STARTRK-NG probe, which evaluated its investigational medicine, entrectinib, for treating children and adolescents with recurrent or refractory solid tumors with and without neurotrophic tyrosine receptor kinase (NTRK), ROS1 or anaplastic lymphoma kinase (ALK) gene fusions.

Data from this analysis showed that entrectinib shrank tumors in all the 11 patients, who had NTRK, ROS1 or ALK fusion-positive solid tumors including two patients achieving a complete response. The company plans to update the details at the annual meeting of American Society of Clinical Oncology in Chicago come Jun 2, 2019.

Zacks Rank

Roche currently carries a Zacks Rank #2 (Buy). Another top-ranked stock in the same sector is Bristol-Myers Squibb Company BMY, which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Bristol-Myers’ earnings estimates have moved 5.2% north for 2020 over the past 60 days.

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