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Roche, AbbVie: Venclyxto Receives Positive Opinion From Committee

- By Alberto Abaterusso

Today Roche (RHHBY) reported a positive opinion concerning Venclyxt (venetoclax) from the European Union Committee for Medicinal Products for Human Use (CHMP).

Venclyxto is used as therapy for chronic lymphocytic leukaemia (CLL) patients who show the presence of 17p deletion or are positive for TP53 mutation. These CLL patients cannot be treated with a B-cell receptor pathway inhibitor or didn't have any positive clinical outcome.

This medication is also strongly suggested to those patients who don't show the presence of 17p deletion or are positive for TP53 mutation and didn't have any positive clinical outcome from chemo-immunotherapy and a B-cell receptor pathway inhibitor as a combined therapy.

"Chronic lymphocytic leukemia (CLL) is a type of cancer that starts from cells that become certain white blood cells (called lymphocytes) in the bone marrow. The cancer (leukemia) cells start in the bone marrow but then go into the blood.

In chronic leukemia, the cells can mature partly but not completely. These cells may look fairly normal, but they are not. They generally do not fight infection as well as normal white blood cells do. The leukemia cells survive longer than normal cells, and build up, crowding out normal cells in the bone marrow. Chronic leukemias can take a long time before they cause problems, and most people can live for many years. But chronic leukemias are generally harder to cure than acute leukemias." -cancer.org

Venclyxto is a small molecule that inhibits a protein called B-cell lymphoma-2 (or BCL-2) and is responsible in a process called apoptosis that is the 'programmed cell death'.

Since high percentages of this protein found in chronic CLL patients have been associated with the failure of therapy, it is believed that inhibiting the BCL-2 may restore the signaling system that brings cells suicide and therefore will improve the outcome for patients with chronic lymphocytic leukemia.

This is an important step moving forward to obtain the authorization to commercialize Venclyxto, which the final decision will be made by the European Commission in the coming months.

Venclexta/Venclyxto (the latter in U.S.) has been co-developed by Roche and AbbVie (ABBV), and is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the United States.

Outside of the U.S., the molecule is commercialized by AbbVie.

At the moment, Roche's shares are going up on the stock market $29.76 +0.06 (0.19%). AbbVie is trading at $60.60 per share and is going slightly down, -0.55 (-0.90%).

Disclosure: I have no positions in any stock mentioned in this article.

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