Fruquintinib에 대한 CHMP의 긍정적인 의견
HUTCHMED Announces Positive CHMP Opinion for Fruquintinib in Previously Treated Metastatic Colorectal Cancer Received by Takeda
- If approved in the European Union, fruquintinib will be the first novel targeted therapy for metastatic colorectal cancer regardless of biomarker status in over a decade -
- Positive opinion based on results from FRESCO‑2 Phase III clinical trial -
홍콩, 상하이 및 뉴저지주 플로햄 공원 - 26년 2024월 XNUMX일 금요일: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) today announces that its partner Takeda (TSE:4502/NYSE:TAK) received notification that the Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency ("EMA") has recommended the approval of fruquintinib for the treatment of adult patients with previously treated metastatic colorectal cancer ("CRC").
The European Commission (EC) will consider the CHMP positive opinion when determining the potential marketing authorization for fruquintinib for metastatic CRC throughout the European Union ("EU"), Norway, Liechtenstein and Iceland. If approved, fruquintinib will be the first and only selective inhibitor of all three vascular endothelial growth factor receptors ("VEGFR") approved in the EU for previously treated metastatic CRC.[1],[2] Takeda has the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside of mainland China, Hong Kong and Macau.
"Through our partnership with HUTCHMED, we have made strides in expanding access to fruquintinib to eligible patients. With this positive CHMP opinion for fruquintinib, we are one step closer to potentially offering patients in the EU an oral, chemotherapy‑free option that can provide a significant survival benefit," said Awny Farajallah, M.D., Chief Medical Officer, Oncology at Takeda. "We look forward to the European Commission's official decision in the near future."
"HUTCHMED has a strong track record of developing innovative oncology medicines for patients in need. People living with metastatic CRC in the EU currently have limited treatment options available to them, which can lead to poor outcomes. We are pleased with our partner Takeda's progress toward redefining the treatment landscape and helping to address a significant unmet need for those affected by metastatic CRC in Europe," said Weiguo Su 박사, HUTCHMED 최고경영자 겸 최고과학책임자. "This novel oncology medicine has had a profound impact for patients in China over the last five years. Since entering our partnership with Takeda we have seen this impact extended with its approval and launch in the U.S. and, pending approval by the European Commission, we look forward to the medicine having a positive effect for patients in Europe too."
The CHMP's positive opinion was primarily based on results from the Phase III multi‑regional FRESCO-2 trial, which supported the Marketing Authorisation Application ("MAA"). The MAA was validated and accepted for review by the EMA in June 2023.
CRC 소개
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, associated with more than 935,000 deaths in 2020. In Europe, CRC was the second most common cancer in 2020, with approximately 520,000 new cases and 245,000 deaths.[3] 미국에서는 153,000년에 53,000명의 환자가 CRC로 진단되고 2024명이 이 질병으로 사망할 것으로 추정됩니다.[4] In Japan, CRC was the most common cancer, with an estimated 148,000 new cases and 60,000 deaths, in 2020.3 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.[5],[6],[7],[8],[9]
About the Phase III FRESCO‑2 Trial
FRESCO‑2 is a multi‑regional clinical trial conducted in the U.S., Europe, Japan and Australia investigating fruquintinib plus best supportive care ("BSC") versus placebo plus BSC in patients with previously treated mCRC (NCT04322539). FRESCO-2 met all of its primary and key secondary endpoints, demonstrating statistically significant and clinically meaningful improvement in overall survival (OS) and progression-free survival (PFS), with consistent benefit among patients treated with fruquintinib, regardless of the prior types of therapies they received. Fruquintinib demonstrated a manageable safety profile in FRESCO‑2, consistent with previously reported fruquintinib studies. Adverse reactions leading to treatment discontinuation occurred in 20% of patients treated with fruquintinib plus BSC versus 21% of those treated with placebo plus BSC. Results from the study were presented at the European Society for Medical Oncology Congress (ESMO) in September 2022 and subsequently published in 랜싯 6월 2023있다.[10],[11]
후루퀸티닙 소개
Fruquintinib is a selective oral inhibitor of VEGFR‑1, ‑2 and ‑3. VEGFR inhibitors play a pivotal role in inhibiting tumor angiogenesis. Fruquintinib was designed to have enhanced selectivity that limits off‑target kinase activity, allowing for high drug exposure, sustained target inhibition, and flexibility for its potential use as part of a combination therapy. Fruquintinib has demonstrated a manageable safety profile and is being investigated in combinations with other anti‑cancer therapies.
About Takeda and FRUZAQLA®
Takeda has the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside of mainland China, Hong Kong and Macau. Fruquintinib received approval in the U.S. in November 2023, where it is marketed by Takeda under the brand name FRUZAQLA®. The U.S. approval was based on data from two large, randomized, controlled Phase III trials, the multi‑regional FRESCO‑2 trial and the FRESCO trial conducted in China, showing consistent benefit among a total of 734 patients treated with fruquintinib. Safety profiles were consistent across trials.
In addition to the submission to the EMA, a submission to the Japan Pharmaceuticals and Medical Devices Agency (PMDA) took place in September 2023.
Fruquintinib 중국 승인 정보
Fruquintinib is approved for marketing in China, where it is co‑marketed by HUTCHMED and Eli Lilly and Company under the brand name ELUNATE®. It was included in the China National Reimbursement Drug List (NRDL) in January 2020. The approval was based on data from the FRESCO study, a Phase III pivotal registration trial of fruquintinib in 416 patients with metastatic colorectal cancer in China, which were published in The Journal of the American Medical Association, JAMA. Since its launch in China and as of mid‑2023, more than 80,000 colorectal cancer patients have been treated with fruquintinib.
HUTCHMED 정보
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial‑stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception it has focused on bringing cancer drug candidates from in‑house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also marketed in the U.S. For more information, please visit: www.hutch‑med.com or follow us on LinkedIn.
미국 중요 안전 정보
경고 및주의 사항
· 고혈압 FRUZAQLA로 치료받은 mCRC 환자 49명 중 911%에서 발생했으며, 그 중 3~4등급 사건은 19%, 고혈압 위기는 0.3명(XNUMX%)에서 발생했습니다. 혈압이 적절하게 조절되지 않는 한 FRUZAQLA를 시작하지 마십시오. 첫 달 동안은 매주 혈압을 모니터링하고 그 이후에는 임상적으로 지시된 대로 최소 한 달에 한 번씩 혈압을 모니터링합니다. 적절하게 항고혈압 치료를 시작하거나 조정합니다. 고혈압의 중증도에 따라 FRUZAQLA를 보류하거나 용량을 줄이거나 영구적으로 중단하십시오.
· 출혈 사건 including serious, fatal events can occur with FRUZAQLA. In 911 patients with mCRC treated with FRUZAQLA, 6% of patients experienced gastrointestinal hemorrhage, including 1% with a Grade ≥3 event and 2 patients with fatal hemorrhages. Permanently discontinue FRUZAQLA in patients with severe or life-threatening hemorrhage. Monitor the International Normalized Ratio (INR) levels in patients receiving anticoagulants.
· 감염. FRUZAQLA는 치명적인 감염을 포함한 감염 위험을 증가시킬 수 있습니다. FRUZAQLA로 치료받은 mCRC 환자 911명에서 가장 흔한 감염은 요로 감염(6.8%), 상기도 감염(3.2%) 및 폐렴(2.5%)이었습니다. 치명적인 감염에는 폐렴(0.4%), 패혈증(0.2%), 세균 감염(0.1%), 하기도 감염(0.1%), 패혈성 쇼크(0.1%)가 포함되었습니다. 3~4등급 감염 또는 모든 등급의 감염이 악화되는 경우 FRUZAQLA를 보류하십시오. 감염이 해결되면 동일한 용량으로 FRUZAQLA를 재개하십시오.
· 위장 천공 occurred in patients treated with FRUZAQLA. In 911 patients with mCRC treated with FRUZAQLA, 1.3% experienced a Grade ≥3 gastrointestinal perforation, including one fatal event. Permanently discontinue FRUZAQLA in patients who develop gastrointestinal perforation or fistula.
· 간독성. FRUZAQLA can cause liver injury. In 911 patients with mCRC treated with FRUZAQLA, 48% experienced increased ALT or AST, including Grade ≥3 events in 5%, and fatal events in 0.2% of patients. Monitor liver function tests (ALT, AST, and bilirubin) before initiation and periodically throughout treatment with FRUZAQLA. Temporarily hold and then reduce or permanently discontinue FRUZAQLA depending on the severity and persistence of hepatotoxicity as manifested by elevated liver function tests.
· 단백뇨. FRUZAQLA는 단백뇨를 유발할 수 있습니다. In 911 patients with mCRC treated with FRUZAQLA, 36% experienced proteinuria and 2.5% of patients experienced Grade ≥3 events. Monitor for proteinuria before initiation and periodically throughout treatment with FRUZAQLA. For proteinuria ≥2g/24 hours, withhold FRUZAQLA until improvement to ≤Grade 1 proteinuria and resume FRUZAQLA at a reduced dose. Discontinue FRUZAQLA in patients who develop nephrotic syndrome.
· 손바닥-발바닥 적혈구감각이상(PPE) FRUZAQLA로 치료받은 환자 35명 중 911%(8등급 사건 3% 포함)에서 발생했습니다. PPE의 중증도에 따라 FRUZAQLA를 중단한 후 동일하거나 감소된 용량으로 재개하십시오.
· 후방 가역성 뇌병증 증후군(PRES), MRI의 특징적 소견으로 진단된 피질하 혈관성 부종 증후군이 FRUZAQLA로 치료받은 환자 911명 중 XNUMX명에서 발생했습니다. 발작, 두통, 시각 장애, 혼란 또는 정신 기능 변화를 보이는 환자의 경우 PRES에 대한 평가를 수행하십시오. PRES가 발생한 환자의 경우 FRUZAQLA를 중단하십시오.
· 손상된 상처 치유. FRUZAQLA로 치료받은 mCRC 환자 911명 중 1명의 환자가 2등급 상처 열개를 경험했습니다. 대수술 전 최소 2주 동안 FRUZAQLA를 투여하지 마십시오. 대수술 후 최소 2주 동안 그리고 상처가 적절하게 치유될 때까지 FRUZAQLA를 투여하지 마십시오. 상처 치유 합병증이 해소된 후 FRUZAQLA 재개에 대한 안전성은 확립되지 않았습니다.
· 동맥 혈전색전증 사건. FRUZAQLA로 치료받은 mCRC 환자 911명 중 0.8%의 환자가 동맥 혈전색전증을 경험했습니다. 최근 혈전색전증 병력이 있는 환자의 경우 FRUZAQLA의 시작을 신중하게 고려해야 합니다. 동맥 혈전색전증이 발생한 환자의 경우 FRUZAQLA를 중단하십시오.
· FD&C Yellow No. 5(Tartrazine) 및 No. 6(Sunset Yellow FCF)에 대한 알레르기 반응. FRUZAQLA 1 mg 캡슐에는 FD&C 황색 5호(타르트라진)가 포함되어 있으며, 이는 민감한 특정 사람에게 알레르기 유형 반응(기관지 천식 포함)을 일으킬 수 있습니다. FRUZAQLA 1 mg에는 알레르기 반응을 일으킬 수 있는 FD&C Yellow No. 6(일몰 노란색 FCF)이 포함되어 있습니다.
· 배아-태아 독성. 동물 연구 결과와 그 작용 메커니즘에 따르면, FRUZAQLA는 임산부에게 투여 시 태아에 해를 끼칠 수 있습니다. 임산부에게 태아에 대한 잠재적 위험에 대해 조언하십시오. 가임기 여성과 가임기 여성 파트너가 있는 남성에게 FRUZAQLA 치료 기간과 마지막 투여 후 2주 동안 효과적인 피임법을 사용하도록 조언하십시오.
이상 반응
The most common adverse reactions (incidence ≥20%) following treatment with FRUZAQLA included hypertension, palmar-plantar erythrodysesthesia (hand-foot skin reactions), proteinuria, dysphonia, abdominal pain, diarrhea, and asthenia.
약물 상호작용: 강력하거나 중간 정도의 CYP3A 유도제와 FRUZAQLA의 병용 투여를 피하십시오.
특정 인구에 사용
· 젖 분비: 여성에게 FRUZAQLA 치료 기간과 마지막 투여 후 2주 동안 모유 수유를 하지 않도록 조언하십시오.
의심되는 이상 반응을 보고하려면 Takeda Pharmaceuticals(1-844-662-8532) 또는 FDA(1-800-FDA-1088)에 문의하십시오. www.fda.gov/medwatch.
Please see FRUZAQLA (fruquintinib) full 처방 정보.
미래 예측 진술
This announcement contains forward‑looking statements within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward‑looking statements reflect HUTCHMED's current expectations regarding future events, including its expectations regarding the review of a MAA for fruquintinib for the treatment of patients with CRC with the EMA and the timing of such review, the therapeutic potential of fruquintinib for the treatment of such patients with CRC and the further clinical development of fruquintinib in this and other indications. Forward‑looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the sufficiency of clinical data to support MAA approval of fruquintinib for the treatment of patients with CRC or other indications in the EU or other jurisdictions such as Japan, its potential to gain approvals from regulatory authorities, the safety profile of fruquintinib, HUTCHMED's ability to fund, implement and complete its further clinical development and commercialization plans for fruquintinib, the timing of these events, each party's ability to satisfy the terms and conditions under the license agreement; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials or the regulatory pathway for fruquintinib; and Takeda's ability to successfully develop and commercialize fruquintinib. In addition, as certain studies rely on the use of other drug products as combination therapeutics with fruquintinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of these therapeutics. Existing and prospective investors are cautioned not to place undue reliance on these forward‑looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED's filings with the U.S. Securities and Exchange Commission, on AIM and on The Stock Exchange of Hong Kong Limited. HUTCHMED undertakes no obligation to update or revise the information contained in this announcement, whether as a result of new information, future events or circumstances or otherwise.
의학 정보
본 발표에는 일부 국가에서 판매되지 않거나, 다른 상표, 다른 적응증, 다른 복용량 또는 다른 강도로 제공될 수 있는 제품에 대한 정보가 포함되어 있습니다. 여기에 포함된 어떠한 내용도 개발 중인 약물을 포함하여 처방약에 대한 권유, 판촉 또는 광고로 간주되어서는 안 됩니다.
내부 정보
이 발표에는 규정(EU) No 7/596의 2014조 목적을 위한 내부 정보가 포함되어 있습니다(유럽 연합(철회) 법 2018에 정의된 유지 EU 법률의 일부를 구성함).
연락처
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