（来源：药研网） 2026年2月23日，诺诚健华官媒宣布，其自主研发的新型BCL2抑制剂mesutoclax（ICP-248） 联合BTK 抑制剂奥布替尼一线治疗慢性淋巴细胞白血病/小淋巴细胞淋巴瘤（CLL/SLL）的注册性III期临床试验 已经完成患者入组。 Mesutoclax是一款新型、口服、高选择性 BCL2抑制剂，BCL2是细胞凋亡通路的重要调控蛋白，其表达 异常与多种恶性血液肿瘤的发生发展相关。Mesutoclax通过选择性抑制BCL2蛋白，恢复肿瘤细胞凋 亡，从而抑制肿瘤生长和扩散。 Mesutoclax与奥布替尼固定疗程联合使用，将为一线CLL/SLL患者提供更深层次的缓解，并避免产生耐 药突变，为一线CLL/SLL患者带来临床治愈希望，成为一种潜力巨大的治疗方案。 去年12月，诺诚健华在ASH年会上公布了mesutoclax多项研究数据。其单药治疗或联合奥布替尼治疗 CLL/SLL显示出良好的疗效和安全性。无论在初治CLL/SLL还是复发/难治性 CLL/SLL（含既往BTK抑 制剂治疗失败）患者中，125毫克mesutoclax剂量组的ORR均为100%。联合奥布替尼治疗36周时，外周 血 ...

AbbVie Inc. (NYSE:ABBV) is one of the best value stocks to buy now. On February 20, the US FDA approved the combination of VENCLEXTA (venetoclax) and acalabrutinib as a first-line treatment for adults with chronic lymphocytic leukemia/CLL. This establishes the first and only all-oral, fixed-duration regimen for previously untreated patients, providing a new alternative to traditional chemoimmunotherapy. By combining two classes of oral medications, the treatment offers patients the potential for periods ...

AbbVie Inc. (NYSE:ABBV) is included among the 14 Best Low Volatility Dividend Stocks to Invest in. Barclays Initiates AbbVie (ABBV) with Overweight Rating on Growth Potential On February 20, Barclays began coverage of AbbVie Inc. (NYSE:ABBV) with an Overweight rating. It set a price target of $275 on the stock. The firm said current consensus estimates do not fully reflect AbbVie’s operating leverage potential. In its note, Barclays added that positive results from any of the company’s proof-of-concept s ...

Core Insights - The FDA has approved the combination treatment of VENCLEXTA® (venetoclax) and acalabrutinib for previously untreated adult patients with chronic lymphocytic leukemia (CLL), marking a significant advancement in treatment options [1][2] Group 1: FDA Approval and Treatment Significance - The approval is based on data from the Phase 3 AMPLIFY trial, establishing this regimen as the first all-oral, fixed-duration treatment for previously untreated CLL patients [1] - This combination offers patients the potential for time off treatment, enhancing long-term disease management [1][3] - The approval expands treatment choices for patients and healthcare providers, facilitating more targeted treatment decisions in CLL [1][3] Group 2: AMPLIFY Study Details - The AMPLIFY trial evaluated VENCLEXTA plus acalabrutinib against chemoimmunotherapy in previously untreated CLL patients without del(17p) or TP53 mutation [1] - Results indicated that the combination regimen reduced the risk of disease progression or death by 35% compared to chemoimmunotherapy (HR 0.65; 95% CI: 0.49-0.87; p=0.0038) [1] - Median progression-free survival (PFS) was not reached for the combination regimen, while it was 47.6 months for chemoimmunotherapy [1] Group 3: Safety Profile - The safety profile of the combination regimen aligns with the known safety profiles of each individual therapy [1] - Common adverse reactions (20%) include neutropenia, headache, diarrhea, musculoskeletal pain, and COVID-19 [1] - Serious adverse reactions (2%) include COVID-19 pneumonia (9%), second primary malignancies (2.7%), and neutropenia (2.1%) [1]

Core Viewpoint - The FDA has approved the combination of Venclexta® (venetoclax) and acalabrutinib for treating previously untreated adults with chronic lymphocytic leukemia (CLL), marking a significant advancement for newly diagnosed patients [1] Company Summary - Genentech, part of the Roche Group, announced the FDA approval based on the Phase III AMPLIFY study results [1]

Core Viewpoint - AbbVie has submitted a supplemental New Drug Application (sNDA) to the FDA for a fixed-duration, all-oral combination regimen of VENCLEXTA® (venetoclax) and acalabrutinib for previously untreated patients with chronic lymphocytic leukemia (CLL), potentially offering a new treatment option with time-limited therapy [1][2]. Group 1: Clinical Trial Results - The submission is based on positive results from the Phase 3 AMPLIFY trial, which demonstrated that the combination of VENCLEXTA and acalabrutinib improved progression-free survival (PFS) compared to standard chemoimmunotherapy in previously untreated CLL patients [2][3]. - The AMPLIFY trial showed a 35% reduction in the risk of disease progression or death with the fixed-duration combination regimen compared to chemoimmunotherapy (HR 0.65; 95% CI: 0.49-0.87; p=0.004) [3]. Group 2: Safety Profile - The safety profile of the VENCLEXTA and acalabrutinib combination is consistent with the known safety profiles of each therapy alone, with common adverse events including neutropenia, hemorrhage, and COVID-19 [3]. - Neutropenia was the most frequent Grade 3 or higher adverse event, occurring in 26.8% of patients, while low rates of tumor lysis syndrome were observed at 0.3% for the combination compared to 3.1% for chemoimmunotherapy [3]. Group 3: Product Information - VENCLEXTA (venetoclax) is a first-in-class medication that selectively inhibits the B-cell lymphoma-2 (BCL-2) protein, which is involved in preventing cancer cell apoptosis [4]. - VENCLEXTA is developed by AbbVie and Roche, and is approved in over 80 countries, including the U.S., with ongoing research into its use across various blood cancers [5]. Group 4: Company Commitment - AbbVie is dedicated to transforming cancer care through a dynamic pipeline of investigational therapies targeting various cancer types, focusing on creating targeted medicines to impede cancer cell reproduction or enable their elimination [23][25].