Vandetanib

Audience: Patient, Pharmacy, Health Care Professional September 25, 2025 -- The U.S. Food and Drug Administration today removed the Risk Evaluation and Mitigation Strategies (REMS) program for Caprelsa ( vandetanib ), a thyroid cancer medication manufactured by Genzyme Corporation (now Sanofi). The FDA first approved Caprelsa in 2011 to treat medullary thyroid cancer in patients whose disease has spread or cannot be surgically removed. At the time, a REMS program was required to ensure appropriate heart rhythm monitoring and safe use. After over more than a decade of oversight, REMS assessments reported no cases of Torsades de pointes or unexplained sudden deaths among U.S. patients taking Caprelsa. Clinical data also showed no concerning patterns of heart rhythm problems. “Cancer specialists now have adequate knowledge about managing the heart rhythm related risks of this medication,” said Richard Pazdur, M.D., FDA Oncology Center of Excellence Director . “Health care providers have incorporated proper safety monitoring into their standard practice, making the formal requirements unnecessary. The mandatory monitoring program has achieved its goals.” Caprelsa will remain available with the same prescribing information, but health care providers will no longer need special certification or extra monitoring beyond standard clinical care. A REMS is a safety program that the FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. The safety requirements for Caprelsa included mandatory training for health care providers and monitoring of patients. Contact Information: Health care providers, pharmacies, and patients with questions may contact the FDA at (855) 543-3784 or (301) 796-3400, or by email at druginfo@fda.hhs.gov. Adverse events, medication errors, or quality problems with Caprelsa should be reported to FDA's MedWatch Adverse Event Reporting program. FDA's top priority is patient safety, and the agency will continue to monitor the safety of this medication. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products. Source: FDA

Caprelsa® (vandetanib) is a medicine that is used in adults and children above 5 years of age to treat aggressive and symptomatic medullary thyroid cancer1. This is a new step forward in ESTEVE's international growth journey focused on highly specialized treatments for high unmet medical and patient needs.  BARCELONA, Spain, June 30, 2025 /PRNewswire/ -- ESTEVE has entered into an agreement with Sanofi to acquire Caprelsa® (vandetanib) rights in more than 50 countries, a treatment that is used in adults and children above 5 years of age to treat aggressive and symptomatic medullary thyroid cancer1. Medullary thyroid carcinoma is a type of cancer that starts in the cells in the thyroid gland that produces the hormone calcitonin. This product is a 'protein tyrosine kinase inhibitor' that blocks the activity of enzymes known as tyrosine kinase. Consequently, the medicine reduces the blood supply to the cancer cells, slowing down the cancer's growth1. "Medullary thyroid carcinoma is a rare neuroendocrine tumor that can produce calcitonin from parafollicular cells. The primary treatment is surgery. However, treatments like vandetanib can often slow down or even partially reverse the tumour growth2. We at ESTEVE are proud to join the fighting effort of the patients diagnosed with this carcinoma and their healthcare professionals, with the ambition to continue improving patient's health and lives", confirms José María Giménez-Arnau, Chief Scientific & Medical Officer of ESTEVE.  In April 2024, ESTEVE acquired a business specialized in rare and ultra-rare diseases in the areas of endocrinology and onco-endocrinology, as a step forward towards becoming a highly specialized company. This acquisition added three new medicines to its portfolio addressing endogenous Cushing's syndrome and Adrenocortical Carcinoma.   Furthermore, last month, ESTEVE acquired a license for a biologic product used to treat children and adolescents from 2 to 18 years-old who suffer from severe primary insulin-like growth factor 1 deficiency3. Building on this, the company last month, the company secured an adjuvant therapy considered the standard of care for high-grade, resectable, non-metastatic osteosarcoma in patients between 2 and 30 years of age4. "We are proud to confirm that we are increasing our highly specialized therapies portfolio. Caprelsa® will help us to improve the lives of patients all around the world. This is a step forward in ESTEVE's international journey focused on highly specialized treatments for high unmet medical needs of patients", concludes Jacob Tolstrup, Chief Commercial Officer of ESTEVE. [The completion of the transaction is subject to obtaining customary regulatory clearances]. References Caprelsa | European Medicines Agency (EMA) Medullary Thyroid Cancer | American Thyroid Association Increlex | European Medicines Agency (EMA)   Mepact I European Medicines Agency (EMA) About ESTEVE ESTEVE () is a global pharmaceutical company with a clear purpose: to improve people's lives. Founded in 1929 and headquartered in Barcelona, ESTEVE has a strong international presence with pharmaceutical affiliates in Spain, Portugal, Italy, Germany, France, the UK, and the USA.   ESTEVE is focused on delivering highly specialized treatments that address significant unmet medical needs in several therapeutic areas. In addition, to our innovative pharma business, we offer comprehensive Contract Manufacturing services (CMO), specializing in the production of Active Pharmaceutical Ingredients (APIs) through world-class facilities in Spain, Mexico, and China.  ESTEVE's strong commitment to its core values—people matter, transparency, and accountability—remains at the heart of everything it does.  For more information: Irene Simón, Head of Global External Communications & ESG, ESTEVE Tel.+34 934 466 000 – [email protected] Gemma Mestre, External & Digital Communications Manager, ESTEVE Tel.+34 934 466 000 – [email protected] Logo - SOURCE ESTEVE WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED