AbbVie的Temab-A获FDA两项突破性疗法认定，覆盖CRC与NSCLC
AbbVie's Telisotuzumab Adizutecan (Temab-A) Receives Two Breakthrough Therapy Designations From the U.S. FDA for CRC and NSCLC
AbbVie宣布FDA授予telisotuzumab adizutecan（Temab-A；ABBV-400）两项突破性疗法认定：联合bevacizumab用于经治难治性转移性结直肠癌，单药用于经治EGFR野生型、c-Met表达的晚期非鳞状非小细胞肺癌。认定主要基于首次人体研究M21-404（NCT05029882），该药尚未获批。
可跟踪Temab-A在CRC与NSCLC的注册推进节奏及M21-404数据读出。
AbbVie's Telisotuzumab Adizutecan (Temab-A) Receives Two Breakthrough Therapy Designations From the U.S. FDA for CRC and NSCLC
- Temab-A is an investigational, next-generation, c-Met-directed antibody-drug conjugate (ADC) with a novel topoisomerase 1 inhibitor (Top1i) being studied in advanced solid tumors including colorectal cancer (CRC) and non-small cell lung cancer (NSCLC)
- These designations represent the first Breakthrough Therapy Designations (BTDs) for Temab-A and further underscore the strength of AbbVie's ADC portfolio, which now includes four BTDs
, /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has granted two Breakthrough Therapy Designations (BTDs) for telisotuzumab adizutecan (Temab-A; ABBV-400) in colorectal cancer (CRC) and non-small cell lung cancer (NSCLC).
Temab-A has received two BTDs: one in combination with bevacizumab for adults with refractory, metastatic CRC who have been previously treated with fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF monoclonal antibody (mAb), and if indicated, anti-EGFR mAb therapy. The second designation is for Temab-A as a monotherapy for adults with locally advanced or metastatic EGFR wild-type, c-Met protein-expressing, non-squamous NSCLC who have previously received treatment with platinum-based chemotherapy and an anti-PD-(L)1 antibody therapy. These designations were primarily based on results from the first-in-human study M21-404 (NCT05029882).
"These Breakthrough Therapy Designations reflect the growing clinical evidence supporting c-Met as a meaningful therapeutic target across multiple solid tumors," said Eleni Lagkadinou, M.D., Ph.D., vice president, oncology early development, AbbVie. "As one of the most advanced assets in our next-generation ADC portfolio, Temab-A has demonstrated potential across multiple tumor types, both as a monotherapy and in combinations. We believe these designations further support our strategy of advancing biomarker-driven therapies and underscore our commitment to developing transformative medicines for patients with difficult-to-treat cancers."
Colorectal and lung cancer together affect more than four million people worldwide each year and remain among the leading causes of cancer-related mortality.1,2 Despite advances in treatment, many patients with CRC and advanced NSCLC continue to experience disease progression, underscoring the need for new therapeutic approaches. The FDA's BTD program is intended to expedite the development and review of investigational medicines with clinical evidence that may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.
Temab-A is an investigational asset and has not been approved for use by global regulatory authorities.
补充资料（4 节）药物、疾病与研究背景 · 公司与合作方信息 · 法律与声明
药物、疾病与研究背景
About Telisotuzumab Adizutecan (Temab-A)
Telisotuzumab adizutecan (Temab-A) is a next-generation, c-Met protein-targeting antibody-drug conjugate (ADC) with a topoisomerase 1 inhibitor (Top1i) payload being investigated in advanced solid tumors including colorectal cancer (CRC) and non-small cell lung cancer (NSCLC). The c-Met protein (also known as MET protein), with increased expression in many solid tumors, may contribute to disease progression and treatment resistance, reinforcing its potential as a promising therapeutic target.
Developed using AbbVie's adizutecan platform, Temab-A combines a validated, humanized bivalent IgG1 monoclonal antibody that binds with high affinity to the c-Met protein with the Top1i payload through a cleavable valine-alanine linker and stable bromoacetamide attachment. This design is intended to support targeted delivery while minimizing systemic payload release.
In addition to CRC and NSCLC, Temab-A is being evaluated across other multiple advanced solid tumors, including head and neck squamous cell carcinoma (HNSCC), gastroesophageal adenocarcinoma (GEA), pancreatic ductal adenocarcinoma (PDAC), and ovarian cancer (OC). The clinical development program includes multiple Phase 3 and Phase 2/3 studies evaluating Temab-A as both a monotherapy and in combination with other therapies across a range of treatment settings. Additional information about ongoing Temab-A clinical trials can be found on clinicaltrials.gov.
公司与合作方信息
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
About AbbVie in Oncology
AbbVie is committed to elevating standards of care and bringing transformative therapies to patients worldwide living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various, targeted treatment modalities and biology interventions, including small molecule therapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based therapeutics, multispecific antibodies and novel CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines.
Today, our expansive oncology portfolio comprises approved and investigational treatments for a wide range of blood cancers and solid tumors. We are evaluating more than 35 investigational medicines in multiple clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit http://www.abbvie.com/oncology.
法律与声明
Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
Global Media: Mabel Martinez
| Investors: Liz Shea |
1 International Agency for Research on Cancer. Lung Cancer Awareness Month 2024. https://www.iarc.who.int/featured-news/lung-cancer-awareness-month-2024/. Accessed October 2026. | ||
2 World Health Organization. Colorectal cancer. https://www.who.int/news-room/fact-sheets/detail/colorectal-cancer. Accessed October 2026. | ||
SOURCE AbbVie
来源：AbbVie｜艾伯维 · news.abbvie.com