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Roche's Leukemia Drug Approved for Next Step in Europe

- By Alberto Abaterusso

Roche (RHHBY) announced on Dec. 8 that Venclyxto (venetoclax), a drug that is used as therapy in patients chronically affected with lymphocytic leukemia, has been authorized by the European Commission, achieving the "conditional marketing."

The Swiss global healthcare company's announcement specifically refers to the following two groups of chronically patients affected with lymphocytic leukemia:

  1. The first group is composed of patients in whom the highest portion of one of the two chromosomes number 17 is lacking, which is a very small portion and is labelled as p, or whose gene TP53 is altered. On these patients, a previous therapy based on the blockage of the protein B, which is considered to be responsible in a process called apoptosis that is the 'programmed cell death', was either unsuccessful or unfeasible.
  2. The second group is composed of patients who don't show the genetic particularities of the aforementioned group. On these patients, a previous therapy based on the blockage of the protein B and a prior chemotherapy together with immunotherapy, were both unsuccessful.

Venclyxto is an organic combination of low molecular weight that inhibits the B-cell lymphoma-2 (or BCL-2) protein. The researchers correlate this protein with the failure of therapy because it was found in high percentages in chronic CLL patients' blood. Therefore, the researchers believe that blocking the BCL-2, the signalling system that brings cells suicide may be repaired and therefore the outcome for patients with chronic lymphocytic leukemia may be improved.

The European Medicines Agency says that "applicants may be granted a conditional marketing authorisation for such medicines where the benefit of immediate availability outweighs the risk of less comprehensive data than normally required."

Furthermore, patients chronically affected with lymphocytic leukemia and who either show anomalies in one of the two chromosomes number 17 or on whom a previous therapy was unsuccessful, "are in particular need of new treatment options as the disease is more difficult to treat and further options are limited," the company says.

"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

Roche (RHHBY) is advancing Venclyxto in cooperation with AbbVie (ABBV).

Roche Group, through one of its subsidiaries, Genentech, together with AbbVie, markets the medication Venclexta/Venclyxto in the U.S. under the name of Venclexta. AbbVie has also the right to market Venclyxto outside the U.S.

Roche closed at $27.86 Friday, up 79 cents or 2.88% from the previous close. The stock lost 19.18% year to date.

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

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