-The European Commission grants Conditional Marketing Authorization for Taiho's LYTGOBI® tablets for the treatment of adults with cholangiocarcinoma

LYTGOBI is the first irreversibly binding FGFR inhibitor in the European Union for use in the treatment of patients with cholangiocarcinoma

ZUG, Switzerland, July 4, 2023 /PRNewswire/ -- Taiho Oncology Europe GmbH and Taiho Pharmaceutical Co., Ltd., today announced that the European Commission has granted a conditional marketing authorization for LYTGOBI® (futibatinib) monotherapy for the treatment of adult patients with metastatic or locally advanced cholangiocarcinoma (CCA) with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that has progressed after at least one prior line of systemic therapy.

CCA is an aggressive cancer of the bile ducts of the liver. Although rare (in Europe, approximately 6,000 to 8,000 people are diagnosed with CCA1), this disease is associated with poor outcomes and its prevalence is increasing worldwide,2 underscoring the need for new treatment options.

"Today is an important day for current and future CCA patients, as well as the healthcare providers who treat them," said Peter Foertig, MD, vice president of medical affairs, Taiho Oncology Europe. "LYTGOBI is a molecularly targeted oral medication that may provide clinically meaningful results for patients undergoing treatment for CCA."

John Bridgewater, MD, PhD, investigator and lead author of the pivotal FOENIX*-CCA2 trial recently published in the New England Journal of Medicine added: "FGFR2 fusions/rearrangements are one of the most common actionable alterations in CCA. As an inhibitor of irreversibly bound FGFR, LYTGOBI addresses FGFR in a unique way and offers new hope in a disease that has, for me, been one of the most difficult to treat in my career." Professor Bridgewater is a Clinical Investigator and Medical Oncologist at University College London Cancer Institute and University College London Hospitals NHS Foundation Trust.

The European Commission's conditional marketing authorization for LYTGOBI is based on data from the aforementioned FOENIX-CCA2 trial, a global open-label trial evaluating 103 patients with unresectable, locally advanced, or intrahepatic (within the bile ducts of the liver) CCA. metastatic disease harboring FGFR2 gene rearrangements, including fusions.

In this trial, patients received LYTGOBI orally once daily at a dose of 20 mg until disease progression or unacceptable toxicity. Within Europe, patients from France, Germany, Italy, the Netherlands, Spain, and the United Kingdom were enrolled.

The results of the FOENIX-CCA2 trial showed:

"I believe LYTGOBI may be part of a new era in CCA treatment, one in which the power of personalized medicine can impact patients' lives in ways we haven't seen before with traditional chemotherapy," he said. Helen Morement, CEO of AAMF: The Cholangiocarcinoma Charity and the only UK charity dedicated to this cause.

"We are grateful to the many patients and healthcare professionals who participated in the FOENIX-CCA2 trial," said Atsushi Azuma, CEO of Taiho Pharmaceutical and President of Taiho Oncology Europe. "CCA patients are often diagnosed at an advanced stage when surgery is not an option. We are pleased that LYTGOBI is now a new treatment option for CCA patients."

Conditional marketing authorization in Europe is granted for medicines that fill an unmet medical need to treat serious diseases, and the benefits of having them available sooner outweigh any risks associated with using the medicines while awaiting further evidence. Under the specific obligation to complete post-authorization steps for conditional marketing authorization, Taiho has until October 2027 to provide additional clinical data on LYTGOBI.

EU Summary of Product Characteristics (SmPC)3 Safety Information

LYTGOBI may cause serious adverse reactions. The most common serious adverse reactions were intestinal obstruction and migraine.

The most common adverse reactions were hyperphosphatemia, nail disorders, constipation, alopecia, diarrhea, dry mouth, fatigue, nausea, dry skin, AST increased, abdominal pain, stomatitis, vomiting, palmar-plantar erythrodysesthesia syndrome, arthralgia, and decreased of appetite.

Prolonged hyperphosphatemia can cause soft tissue mineralization, including skin calcification, vascular calcification, and myocardial calcification, anemia, hyperparathyroidism, and hypocalcemia that can cause muscle cramps, QT prolongation, and arrhythmias. Hyperphosphatemia is an expected pharmacodynamic effect with LYTGOBI administration. Recommendations for the management of hyperphosphatemia include dietary phosphate restriction, administration of phosphate-reducing therapy, and dose modification when necessary.

LYTGOBI can cause serous retinal detachment, which may present with symptoms such as blurred vision, floaters, or photopsia. An ophthalmologic examination should be performed prior to initiation of therapy, 6 weeks thereafter, and urgently at any time for visual symptoms. For serous retinal detachment reactions, dose modification guidelines should be followed.

LYTGOBI should not be used during pregnancy unless the clinical condition of the woman requires treatment with LYTGOBI.

About Taiho Oncology Europe Taiho Oncology Europe's mission is to improve the lives of cancer patients, their families and their caregivers. The company specializes in orally administered anticancer agents and has a growing portfolio of targeted anticancer agents. Taiho Oncology Europe GmbH (Zug, Switzerland) is the European subsidiary of Taiho Pharmaceutical Co., Ltd. (Tokyo, Japan). For more information visit www.taihooncology.eu

About Taiho Pharmaceutical Co., Ltd.Taiho Pharmaceutical Co., Ltd., a subsidiary of Otsuka Holdings Co., Ltd., is an R&D-driven specialty pharmaceutical company with a focus on oncology. Taiho Pharmaceutical also has development programs in allergy and immunology, urology, and consumer healthcare products. Our corporate philosophy takes the form of a commitment: "We strive to improve human health and contribute to a society enriched by smiles." For more information about Taiho Pharmaceutical Co., Ltd., please visit: https://www.taiho.co.jp/en/

LYTGOBI is a registered trademark of Taiho Pharmaceutical Co., Ltd.

* The FOENIX-CCA2 trial is a Phase 1/2 study of TAS-120 in patients with advanced solid tumors harboring FGF/FGFR aberrations: FGFR Oral SElective Novel Inhibitor X [across] tumors

Taiho Oncology Europe Media Contact: Judy Kay Moore 1 574-526-2369jumoore@taihooncology.com www.taihooncology.com

Contact para medios de Taiho Pharmaceutical: Junko Onishi 81-3-34293-2878th-koho@taiho.co.jp https://www.taiho.co.jp/en/

References: 1 Kirstein MM, Vogel A. Epidemiology and risk factors of cholangiocarcinoma. Visc Med. 2016;32(6):395-400. Available at: https://pubmed.ncbi.nlm.nih.gov/28229073.... Last accessed: May 2023. 2 Banales JM, Marin JJG., Lamarca A. et al. Cholangiocarcinoma 2020: the next horizon in mechanisms and management. Nat Rev Gastroenterol Hepatol. 2020;17:557–588. Available at : https://www.nature.com/articles/s41575-020-0310-z

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