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Roche leukemia med called breakthrough by FDA

July 29, 2017

Pharma giant Roche (RHHBY) snagged the U.S. Food and Drug Administration’s Breakthrough Therapy Designation for its acute myeloid leukemia drug, Venclexta.

The designation was awarded for the drug in combination with low dose cytarabine (LDAC) to treat elderly patients with previously untreated AML who are ineligible for intensive chemotherapy, the company announced this morning. This is the fourth breakthrough designation awarded to Venclexta (venetoclax). Roche subsidiary Genentech (RHHBY) has teamed up with Illinois-based AbbVie(ABBV) to co-develop and commercialize the drug. AbbVie will be responsible for commercialization outside of the United States.

Venclexta is a small molecule designed to selectively bind and inhibit the B-cell lymphoma 2 (BCL-2) protein. That protein plays an important role in programed cell death, also called apoptosis. The company said it’s believed that blocking the BCL-2 protein may restore the “signaling system” that will tell cells, including cancer cells, it’s time to self-destruct.

In its announcement, Roche said the FDA awarded the Breakthrough Therapy Designation based on data from an ongoing open-label phase Ib study of Venclexta in combination with LDAC to treat the AML patients. Roche added that preliminary data from the study, which was presented at the 22nd European Hematology Association (EHA) Annual Congress last month in Spain, “showed durable efficacy with an acceptable safety profile for Venclexta in combination with LDAC in this patient group.”

Acute myeloid leukemia is an aggressive form of the disease and has one of the lowest survival rates of all types of leukemia. Approximately 20,000 people in the United States and 18,000 in Europe are diagnosed with AML each year, according to Roche’s data.

In April 2016, the FDA approved Venclexta for the treatment of patients with chronic lymphocytic leukemia (CLL) who have a chromosomal abnormality called 17p deletion and who have been treated with at least one prior therapy. Venclexta is the first FDA approved drug to target the BCL-2 protein. Genentech and AbbVie also co-developed the drug for this indication.

In addition to the AML trial and the approval for the rare form of CLL, AbbVie and Roche are collaborating on several Phase III trials studying Venclexta as a treatment for relapsed, refractory and previously untreated chronic lymphocytic leukemia, along with studies in several other cancers.

Shortly after winning approval for Venclexta in CLL, Genentech forged a partnership with California-based Astex Pharmaceuticals to develop a combination treatment for acute myeloid leukemia. The two companies inked a deal to explore the combination of Astex’s next generation hypomethylating agent, guadecitabine (SGI-110), with Genentech’s anti-PD-L1 monoclonal antibody, atezolizumab.

Genentech is also combining atezolizumab with Israel-based BioLine RX Ltd.’s BL-8040, a CXCR4 antagonist, to target AML.

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