SPRING SILVER, Md., April 17, 2020 / PRNewswire / – Today, as part of Orbis ProjectThe US Food and Drug Administration has approved Tukysa (tucatinib) in combination with chemotherapy (trastuzumab and capecitabine) for the treatment of adult patients with a form of HER2-positive breast cancer that cannot be removed surgically, or has spread to other countries. body parts, including the brain, and who have received one or more previous treatments.

The FDA collaborates with the Australian Therapeutic Goods Administration (TGA), Health Canada, Health Sciences Authority (HSA), Singapore) and Swissmedic (SMC, Switzerland) on this review. This is the first Orbis Project partnership between the FDA, HSA and Swissmedic. While the FDA approved Tukysa today, the application is still under review at other agencies. Collaboration between international regulators can allow patients with cancer to receive prior access to products in other countries where there may be significant delays in shipping regulations, regardless of whether the product has received FDA approval. The initial availability of new therapies and adoption as standard of care throughout the world can have an impact on the increasing number of international cancer clinical trials, which has the potential to accelerate the development of anticancer products. With a framework for concurrent submission and oncology drug review, Project Orbis facilitates collaborative review to identify any regulatory differences between the review teams.

“The Orbis FDA project provides a framework for concurrent submission and review of oncology drug applications among FDA international collaborators. We are pleased to work with us. Singapore and Switzerland colleagues for the first time, and to continue working with our Australian and Canadian colleagues as we facilitate new treatment options for patients – such as the first new molecular entity under the Orbis Project, “said Richard Pazdur, M.D., director of the FDA’s Center for Oncology and managing director of the Office of Oncology at the FDA’s Center for Drug Evaluation and Research. “This agreement is an additional targeted treatment option for patients with HER2-positive breast cancer. Clinical trials that support this agreement register and specifically study patients with active brain metastases in addition to the entire population listed, which also shows benefits in this subgroup.”

HER2-positive breast cancer, which makes up about one-fifth of breast cancer, has too much protein called the human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells. More than 25% of women with HER2-positive metastatic breast cancer will develop brain metastases.

“We are aware that patients with cancer are a vulnerable population who are at risk of contracting coronavirus,” Pazdur said. “In this critical period, we remain steadfast in our commitment to patients with cancer and do everything we can to accelerate the development of oncology products. Tukysa was approved four months before the FDA’s destination date, giving examples of these commitments and showing how regularly we commit. work in reviewing treatments for patients with cancer moving forward without delay. “

Tukysa is a kinase inhibitor which means it inhibits a type of enzyme (kinase) and helps prevent the growth of cancer cells. Tukysa is approved for treatment after patients use one or more HER2-based regimens in the setting of metastases. The FDA approved Tukysa based on the results of clinical trials that enrolled 612 patients with advanced non-resectionable breast cancer or HER2-positive metastases and underwent previous treatment with trastuzumab, pertuzumab and ado-trastuzumab emtansine (T-DM1). Patients with previously treated and stable brain metastases, as well as those with brain metastases that were previously treated and growing or not treated, were eligible for clinical trials, and 48% of patients registered had brain metastases at the start of the trial.

The primary endpoint is development-free survival (PFS), or the amount of time when there is no tumor growth. The median PFS in patients who received Tukysa, trastuzumab, and capecitabine was 7.8 months compared with 5.6 months in patients who received placebo, trastuzumab, and capecitabine. Overall survival and PFS in patients with brain metastases at baseline are key secondary end points. The median overall survival in patients receiving Tukysa, trastuzumab, and capecitabine was 21.9 months compared with 17.4 months in patients who received placebo, trastuzumab, and capecitabine. The median PFS in patients with baseline brain metastases who received Tukysa, trastuzumab and capecitabine was 7.6 months compared with 5.4 months in patients who received placebo, trastuzumab and capecitabine.

Common side effects for patients taking Tukysa are diarrhea, palmar-plantar erythrodysesthesia (discomfort in hands and feet), nausea, fatigue, hepatotoxicity (liver damage), vomiting, stomatitis (inflammation of the mouth and lips), decreased appetite, pain stomach, headache, anemia and rash.

Tukysa can cause serious side effects including severe diarrhea associated with dehydration, acute kidney injury, and death. Health care professionals should advise patients to inform their health care providers and start antidiarrheals as clinically indicated if diarrhea occurs. If the patient has severe diarrhea, Tukysa must be stopped or the dose reduced. Tukysa can also cause severe hepatotoxicity. Health care professionals must monitor liver tests in patients taking Tukysa every three weeks while the patient is being treated or as clinically indicated.

Women who are pregnant or breastfeeding should not use Tukysa because it can cause damage to the developing fetus or newborn baby. The FDA advises health care professionals to tell women about their reproductive potential and men with female partners of reproductive potential to use effective contraception during treatment with Tukysa and for at least one week after the last dose. The FDA also recommends that patients refer to the Complete Prescribing Information of trastuzumab and capecitabine for information on pregnancy and contraception.

In addition to international collaboration with TGA, Health Canada, HSA Singapore and SMC Switzerland, this review uses Pilot Real-Time Oncology Review (RTOR) pilot program, which can streamline data submission before completion and submission of all clinical applications. RTOR, as well Assessment Assistance, discussions facilitated between regulatory bodies and regulatory review.

The FDA provided this application Priority Review and Breakthrough Therapy designation, which accelerates the development and review of drugs intended to treat serious conditions, when preliminary clinical evidence suggests that the drug can show substantial improvement compared to available therapies. Tukysa is also given Fast Track designation, which speeds up the review of drugs to treat serious conditions and meet unmet medical needs. Tukysa accepted Orphan Medicine designation, which provides incentives to help and encourage the development of drugs for rare diseases.

The FDA gave Tukysa approval to Seattle Genetics, Inc.

Additional resources:

Media Contact: Nathan Arnold, (301) 796-6248
Consumer Questions: Email or 888-INFO-FDA

The FDA, a body within the U.S. Department of Health and Human Services, protects public health by ensuring the safety, effectiveness and safety of human and animal medicines, vaccines and other biological products for human use, and medical devices. This agency is also responsible for the safety and security of our country’s food supply, cosmetics, food supplements, products that emit electronic radiation, and for regulating tobacco products.

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