New Medication Brings Hope for AML Leukemia Patients


Photo: leukemia-cell.org

By THÉRÈSE MARGOLIS   

It is the most common form of acute leukemia in adults, and one of the most aggressive and lethal cancers known to man.

Originating in the bone marrow, acute myeloid leukemia (AML) is a condition in which the body produces too many myeloid white blood cells that flood the bloodstream and block the production and function of other blood cells.

Moreover, the myeloid white blood cells produced in AML patients are usually defective and cannot fight off infections and other diseases.

AML usually occurs in patients over 60, and is slightly more common in men than in women (although doctors do not know exactly why).

Until recently, the prognoses for surviving acute myeloid leukemia were depressingly grim, with less than a quarter of victims still alive six months after their first diagnosis.

Every year in Mexico, about 5,000 people die from AML, according to estimates from the Secretariat of Health (SSA), and while some patients do react favorably to high-dose chemotherapy, the treatment is usually very traumatic and often excruciating for elderly patients, who do not have the same tolerance to the drugs that younger patients do.

But earlier this year, the Chicago-based biopharmaceutical company AbbVie (a corporate spinoff of Abbott Laboratories, best known for its branded generic pharmaceuticals, medical devices, diagnostics and nutrition products) received permission from the Mexican Health Secretariat’s Federal Commission for the Protection against Sanitary Risks (Cofepris) to use Venclexta – a drug already approved for the treatment of chronic lymphocytic leukemia (CLL, another form of leukemia that affects lymphocytic white blood cells instead of myeloid cells) – to treat newly diagnosed AML patients who are not candidates for chemotherapy.

Venclexta (known generically as venetoclax), which received an accelerated approval by the U.S. Food and Drug Administration (FDA) in November of last year for the same alternative use in treating AML patients, is an oral B-cell lymphoma inhibitor, which essentially means that it works by slowing the production of out-of-control immune system lymphocyte cells, which cause CLL.

After initial trials with the drug showed that it could also slow the production of myeloid cells, Venclexta got an FDA fast-track approval for its use in the treatment of AML.

So far, only a few Mexicans have received the new treatment, most under the care of hematologist and oncologist Fernando Pérez Zincer of the Hospital Ángeles Lomas and ABC Medical Center’s Observatorio Campus.

“Right now, my colleagues and I are treating seven AML patients with the drug, and all of them have shown remarkable results,” Pérez Zincer told a group of medical reporters during a press conference organized by AbbVie to announce the new Cofepris approval of Venclexta for the treatment of acute myeloid leukemia.

“In some cases, we have seen what seems to be total remission of the disease.”

Pérez Zincer, who specifically avoided mentioning the drug by name in keeping with Mexican medical standards, said that the normal protocol for AML patients taking Venclexta is for them to be given the oral medication in doses starting at 100 milligrams a day and gradually increasing up to 400 milligrams a day over a six-month period.

He said that, unlike chemotherapy, which can lead to severe side effects ranging from nausea and hair loss to full incapacitation requiring hospitalization, patients receiving Venclexta have very few and minor adverse reactions.

“Some patients do get anemia and are more susceptible to infections, and they may feel weak or have nose or gum bleeds,” Pérez Zincer said.

“But for the most part, they do not require hospitalization, which is a big advantage over chemotherapy.”

Pérez Zincer said that some AML patients are also given low-dose chemotherapy in combination with Venclexta, but do not require the high dosages of chemotherapeutic agents that patients not given Venclexta must endure, which means that the chemo side effects are far less severe.

Venclexta has also been linked to kidney failure in some patients, and there have been reports of low-grade fever, swelling of the limbs, muscle pain and respiratory problems.

Treatment with Venclexta is not cheap: A month’s supply of the drug can run between $8,000 and $9,000.

But Pérez Zincer and AbbVie medical director for Mexico José Luis Cañadas, who also spoke at the conference, both defended the cost, pointing to the high price of chemotherapy and hospitalization, which, they said, is almost always required for normal AML patients.

“The drug is costly, but you cannot put a price on a person’s health,” said Cañadas.

“This is a groundbreaking treatment that can dramatically extend the life expectancy of AML patients.”

Cañadas also said that the treatment is usually covered by most private-sector health insurance plans.

AbbVie is currently in negotiations with the Mexican government to have it included in public health institutions.

“Not all AML patients react favorably to the treatment, but about 60 to 70 percent do,” Pérez Zincer said.

“That is a significant number. Treatment of AML patients with the AbbVie medication is still new, and we have yet to see the long-term results, but based on what we have seen, there is no denying that this is a watershed drug that will no doubt end up being used to treat other types of leukemia, perhaps even childhood leukemia.”

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