FDA approves new treatment for
certain advanced or metastatic breast cancers
O FDA aprovou no dia 28/09/17
o Verzenio (abemaciclib) para tratar pacientes adultos que possuem câncer de
mama avançado ou metastático, que evoluiu após ter sido feita a terapia que
altera hormônios do paciente (terapia endócrina).
Verzenio é aprovado para ser
administrado em combinação com uma terapia endócrina, chamada fulvestrant, após
o câncer ter crescido na terapia endócrina. Também é aprovado para ser
administrado sozinho , se os pacientes foram previamente tratados com terapia
endócrina e quimioterapia após o câncer ter se espalhado.
"O Verzenio oferece uma
nova opção de tratamento dirigido a certos pacientes com câncer de mama que não
tem respondido ao tratamento, e diferente de outros fármacos da classe, pode
ser administrado como um tratamento independente a pacientes que foram tratados
previamente com terapia endócrina e quimioterapia, " disse Richard Pazdur,
diretor do Centro de Excelência e Oncologia do FDA.
O FDA concedeu a aprovação do
Verzenio à Eli Lilly and Company.
Maiores informações no
release, abaixo:
The U.S. Food and Drug
Administration today approved Verzenio (abemaciclib) to treat adult patients
who have hormone receptor (HR)-positive, human epidermal growth factor receptor
2 (HER2)-negative advanced or metastatic breast cancer that has progressed
after taking therapy that alters a patient’s hormones (endocrine therapy).
Verzenio is approved to be given in combination with an endocrine therapy,
called fulvestrant, after the cancer had grown on endocrine therapy. It is also
approved to be given on its own, if patients were previously treated with
endocrine therapy and chemotherapy after the cancer had spread (metastasized).
"Verzenio provides a new
targeted treatment option for certain patients with breast cancer who are not
responding to treatment, and unlike other drugs in the class, it can be given
as a stand-alone treatment to patients who were previously treated with
endocrine therapy and chemotherapy," said Richard Pazdur, M.D., director
of the FDA’s Oncology Center of Excellence and acting director of the Office of
Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and
Research.
Verzenio works by blocking
certain molecules (known as cyclin-dependent kinases 4 and 6), involved in
promoting the growth of cancer cells. There are two other drugs in this class
that are approved for certain patients with breast cancer, palbociclib approved
in February 2015 and ribociclib approved in March 2017.
Breast cancer is the most
common form of cancer in the United States. The National Cancer Institute at
the National Institutes of Health estimates approximately 252,710 women will be
diagnosed with breast cancer this year, and 40,610 will die of the disease.
Approximately 72 percent of patients with breast cancer have tumors that are
HR-positive and HER2-negative.
The safety and efficacy of
Verzenio in combination with fulvestrant were studied in a randomized trial of
669 patients with HR-positive, HER2-negative breast cancer that had progressed
after treatment with endocrine therapy and who had not received chemotherapy
once the cancer had metastasized. The study measured the length of time tumors
did not grow after treatment (progression-free survival). The median
progression-free survival for patients taking Verzenio with fulvestrant was
16.4 months compared to 9.3 months for patients taking a placebo with
fulvestrant.
The safety and efficacy of
Verzenio as a stand-alone treatment were studied in a single-arm trial of 132
patients with HR-positive, HER2-negative breast cancer that had progressed
after treatment with endocrine therapy and chemotherapy after the cancer
metastasized. The study measured the percent of patients whose tumors
completely or partially shrank after treatment (objective response rate). In
the study, 19.7 percent of patients taking Verzenio experienced complete or
partial shrinkage of their tumors for a median 8.6 months.
Common side effects of
Verzenio include diarrhea, low levels of certain white blood cells (neutropenia
and leukopenia), nausea, abdominal pain, infections, fatigue, low levels of red
blood cells (anemia), decreased appetite, vomiting and headache.
Serious side effects of
Verzenio include diarrhea, neutropenia, elevated liver blood tests and blood
clots (deep venous thrombosis/pulmonary embolism). Women who are pregnant
should not take Verzenio because it may cause harm to a developing fetus.
The FDA granted this
application Priority Review and Breakthrough Therapydesignations.
The FDA granted the approval
of Verzenio to Eli Lilly and Company.
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