FDA Approves New Metastatic Breast Cancer Drug
The FDA also advised that women who are pregnant or breastfeeding should not take Tukysa.
The US Food and Drug approved the use of the drug tucatinib or Tukysa for the treatment of advanced HER2-positive breast cancer.
This drug will be given in combination with chemotherapy to patients who have received one or more prior treatments for their cancer, the FDA announced in a press release on Friday, 17 April.
The drug is a kinase inhibitor which means it blocks the enzyme kinase and prevents cancer cells from growing.
Seattle Genetics, Inc got the approval for the breast cancer drug by the FDA. This approval came as part of Project Orbit which is an initiative by the FDA.
“This approval represents an additional targeted treatment option for patients with HER2-positive breast cancer,” said Dr Richard Pazdur, director of the FDA's Oncology Center of Excellence, said the press release.
Dr Pazdur acknowledged that the patients with cancer constitute a vulnerable population at risk of contracting the coronavirus disease.
“In this critical time, we remain steadfast in our commitment to patients with cancer and doing everything we can to expedite oncology product development. Tukysa was approved four months prior to the FDA goal date, providing an example of this commitment and showing how our regular work in reviewing treatments for patients with cancer is moving forward without delay.”Dr Richard Pazdur, Director, FDA’s Oncology Center of Excellence
The approval of this breast cancer drug, Tukysa, was based on the results of a clinical trial enrolling 612 patients with advanced HER2-positive metastatic breast cancer. It was found that adding the drug tucatinib to a chemotherapy treatment consisting of the drugs trastuzumab and capecitabine could improve survival for those patients.
The patients in the study were randomly assigned to wither receive the drug tucatinib or placebo. The primary endpoint was progression-free survival (PFS), or the amount of time when there was no growth of the tumour.
The median PFS in patients who received Tukysa was 7.8 months compared to 5.6 months in those patients who received placebo.
Common side effects that emerged for patients taking tucatinib were diarrhoea, nausea, fatigue, hepatotoxicity (liver damage), vomiting, stomatitis (inflammation of the mouth and lips), decreased appetite, abdominal pain, headache, anaemia and rash.
“Health care professionals should advise patients to notify their health care provider and start antidiarrheals as clinically indicated if diarrhoea occurs. If patients are experiencing severe diarrhoea, Tukysa should be interrupted or the dosage reduced.” The FDA announcement said.
The FDA also advised that women who are pregnant or breastfeeding should not take Tukysa because it may cause harm to a developing fetus or newborn baby.
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