FDA Approves First New Drug Under International Collaboration, A Treatment Option for Patients with HER2-Positive Metastatic Breast Cancer

https://www.fda.gov/news-events/press-announcements/fda-approves-first-new-drug-under-international-collaboration-treatment-option-patients-her2?utm_campaign=FDA%20approves%20new%20treatment%20for%20HER2-positive%20metastatic%20breast%20cancer&utm_medium=email&utm_source=Eloqua


FDA Approves First New Drug Under International Collaboration, A Treatment Option for Patients with HER2-Positive Metastatic Breast Cancer 

Today, as part of Project Orbis, the U.S. Food and Drug Administration approved Tukysa (tucatinib) in combination with chemotherapy (trastuzumab and capecitabine) for the treatment of adult patients with advanced forms of HER2-positive breast cancer that can’t be removed with surgery, or has spread to other parts of the body, including the brain, and who have received one or more prior treatments. The FDA collaborated 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 Project Orbis partnership between the FDA, HSA and Swissmedic. While the FDA approved Tukysa today, the application is still under review at the other agencies. Collaboration among international regulators may allow patients with cancer to receive earlier access to products in other countries where there may be significant delays in regulatory submissions, regardless of whether the product has received FDA approval. Early availability of new therapies and adoption as standard of care around the world may have an impact on the increasingly international conduct of cancer clinical trials, potentially accelerating the development of anticancer products. With a framework for concurrent submission and review of oncology drugs, Project Orbis facilitates a collaborative review to identify any regulatory divergence across review teams. Common side effects for patients taking Tukysa were diarrhea, palmar-plantar erythrodysesthesia (burning or tingling discomfort in the hands and feet), nausea, fatigue, hepatotoxicity (liver damage), vomiting, stomatitis (inflammation of the mouth and lips), decreased appetite, abdominal pain, 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 notify their health care provider and start antidiarrheals as clinically indicated if diarrhea occurs. If patients are experiencing severe diarrhea, Tukysa should be interrupted or the dosage reduced. Tukysa can also cause severe hepatotoxicity. Health care professionals should monitor liver tests in patients taking Tukysa every three weeks while the patient is on treatment or as clinically indicated. Women who are pregnant or breastfeeding should not take Tukysa because it may cause harm to a developing fetus or newborn baby. The FDA advises health care professionals to tell females of reproductive potential and males 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 advises patients refer to the Full Prescribing Information of trastuzumab and capecitabine for pregnancy and contraception information.

Read More