Regorafenib

Takeda holds the licence for developing, marketing and manufacturing fruquintinib outside of mainland China, Hong Kong and Macau. Credit: Tada Images / Shutterstock. The European Commission (EC) has approved Takeda’s Fruzaqla (fruquintinib) as a monotherapy for adults with metastatic colorectal cancer who have exhausted currently available standard therapies. This approval is for patients who have advanced on or are not tolerant to treatments including trifluridine-tipiracil and regorafenib. In April 2024, the treatment received a positive opinion from the Committee for Medicinal Products for Human Use. The latest development comes after the US Food and Drug Administration (FDA) granted approval for the same indication in November 2023 . The approval is based on data from the Phase III multi-regional FRESCO-2 trial assessing Fruzaqla along with best supportive care (BSC) versus placebo plus BSC. See Also: Johnson & Johnson seeks FDA approval for Tremfya for Crohn’s disease AstraZeneca’s Truqap and Faslodex combo receives approval in EU The trial met all primary and key secondary efficacy endpoints with the treatment demonstrating benefit regardless of patients’ previous therapy types. The oral inhibitor had a manageable safety profile with adverse reactions that led to discontinuation of treatment. Takeda holds the sole global licence for developing, marketing and manufacturing fruquintinib outside mainland China, Hong Kong and Macau. A submission for Fruzaqla was made to the Japan Pharmaceuticals and Medical Devices Agency in September 2023. Fruquintinib is developed and marketed by Hutchmed in China. It was first approved by the China National Medical Products Administration in September 2018 and commercially launched in China in November of the same year under the brand name ELUNATE. Takeda Global oncology business unit president Teresa Bitetti stated: “The approval marks an important moment for the colorectal cancer community in the EU. For the first time in over a decade, patients with previously treated metastatic colorectal cancer have a new targeted treatment option that can be used irrespective of whether their tumours harbour actionable mutations.”

− Approval Based on Results from Positive, Global, Phase 3 FRESCO-2 Trial − FRUZAQLA (fruquintinib) is the First Novel Targeted Therapy in the EU for Metastatic Colorectal Cancer (mCRC) Regardless of Biomarker Status in Over a Decade OSAKA, Japan & CAMBRIDGE, MA, USA I June 21, 2024 I Takeda ( TSE:4502/NYSE:TAK ) today announced that the European Commission (EC) approved FRUZAQLA (fruquintinib) as a monotherapy indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents, and who have progressed on or are intolerant to treatment with either trifluridine-tipiracil or regorafenib. The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on April 25, 2024, and approval by the U.S. Food and Drug Administration (FDA) for adults with mCRC who have been previously treated with oxaliplatin- and irinotecan-based regimens on November 8, 2023. 1,2 “People living with metastatic colorectal cancer face numerous difficulties, stemming both from their illness and the adverse effects of therapies. Given the complex nature of the disease, introducing innovative treatments such as fruquintinib – an oral, chemotherapy-free targeted agent – is essential. I am looking forward to having a new choice for appropriate patients,” said Josep Tabernero, MD, PhD, director of Vall d´Hebron Institute of Oncology (VHIO). The approval is based on results from the Phase 3 multi-regional FRESCO-2 trial. The trial investigated FRUZAQLA plus best supportive care (BSC) versus placebo plus BSC in patients with previously treated mCRC. FRESCO-2 met all its primary and key secondary efficacy endpoints and showed consistent benefit among patients treated with FRUZAQLA, regardless of the prior types of therapies they received. FRUZAQLA demonstrated a manageable safety profile in FRESCO-2. Adverse reactions leading to treatment discontinuation occurred in 20% of patients treated with FRUZAQLA plus BSC versus 21% of those treated with placebo plus BSC. Data from FRESCO-2 were published in The Lancet in June 2023. 3 “Today’s approval marks an important moment for the colorectal cancer community in the EU. For the first time in over a decade, patients with previously treated metastatic colorectal cancer have a new targeted treatment option that can be used irrespective of whether their tumors harbor actionable mutations,” said Teresa Bitetti, president of the Global Oncology Business Unit at Takeda. “We look forward to offering patients a novel treatment option that has a manageable safety profile and can be effective regardless of the prior types of therapies they have received.” About FRUZAQLA (fruquintinib) FRUZAQLAis a selective oral inhibitor of all three VEGF receptors (-1, -2 and -3). VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. FRUZAQLAwas designed to have enhanced selectivity that limits off-target kinase activity, allowing for high drug exposure, sustained target inhibition, and flexibility for potential use as part of combination therapy. Takeda has the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside of mainland China, Hong Kong and Macau. FRUZAQLA was approved by the U.S. Food and Drug Administration (FDA) in November 2023. A submission to the Japan Pharmaceuticals and Medical Devices Agency (PMDA) took place in September 2023. Fruquintinib is developed and marketed in China by HUTCHMED. Fruquintinib was approved for marketing by the China National Medical Products Administration (NMPA) in September 2018 and commercially launched in China in November 2018 under the brand name ELUNATE ® . About CRC CRC is a cancer that starts in either the colon or rectum. According to the International Agency for Research on Cancer, CRC is the third most prevalent cancer worldwide and was associated with more than 1.9 million new cases and 900,000 deaths in 2022. In Europe, CRC was the second most common cancer in 2022, with approximately 538,000 new cases and 248,000 deaths. 4 In the U.S., it is estimated that 153,000 patients will be diagnosed with CRC and 53,000 deaths from the disease will occur in 2024. 5 In Japan, CRC was the most common cancer in 2022, with more than 145,000 new cases and 60,000 deaths. 4 Although early-stage CRC can be surgically resected, metastatic CRC remains an area of high unmet need with poor outcomes and limited treatment options. Some patients with metastatic CRC may benefit from personalized therapeutic strategies based on molecular characteristics; however, most patients have tumors that do not harbor actionable mutations. 6,7,8,9,10 About the Phase 3 FRESCO-2 Trial The FRESCO-2 study is a multi-regional clinical trial conducted in the U.S., Europe, Japan and Australia investigating FRUZAQLA plus BSC vs placebo plus BSC in patients with previously treated mCRC ( NCT04322539 ). The study met all of its primary and key secondary endpoints, demonstrating that treatment with FRUZAQLA resulted in statistically significant and clinically meaningful improvement in OS and PFS. The safety profile of FRUZAQLA in FRESCO-2 was consistent with previously reported fruquintinib monotherapy studies. Results from the study were presented at ESMO in September 2022 and subsequently published in The Lancet in June 2023. 11,3 About Takeda Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. 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References: SOURCE: Takeda Pharmaceutical Co