Venetoclax

STEERLife Unveils Solvent-Free Melt Fusion Technology for Potent Drug Development

8 days ago

• STEERLife has introduced a groundbreaking solvent-free melt fusion technology that eliminates harmful organic solvents in pharmaceutical manufacturing, enhancing safety and efficiency. • The company has initiated development of generic versions of several high-potency drugs including Apalutamide, Enzalutamide, Venetoclax, and Olaparib, with market releases planned from 2026. • Through strategic partnerships, STEERLife aims to serve pharmaceutical markets across multiple regions including the United States, Europe, Latin America, and Asia.

Balancing Efficacy and Cost Sustainability in Modern CLL Treatment: Insights from Dr. Pierluigi Porcu

a month ago

• Clinicians treating chronic lymphocytic leukemia (CLL) face growing challenges in balancing clinical efficacy with long-term cost sustainability, requiring a holistic approach to patient care. • Dr. Pierluigi Porcu emphasizes that effective CLL management requires understanding disease risk, patient comorbidities, and practice environment constraints including payer considerations. • Despite its importance, value-based care adoption remains insufficient in oncology, with challenges in defining and measuring value across patient outcomes, quality of life, and treatment costs.

Omeros Forms Elite Clinical Steering Committee to Advance Novel AML Therapeutic Program

a month ago

• Omeros Corporation has established an Oncology Clinical Steering Committee comprising eight distinguished leukemia experts from leading cancer centers to guide its OncotoX-AML program development. • The OncotoX-AML therapeutic has demonstrated superior efficacy to current standard treatments in preclinical studies, effectively targeting 90% of common AML mutations while showing excellent tolerability at high doses. • The novel engineered molecules, approximately half the size of antibodies, selectively kill dividing cancer cells including treatment-resistant leukemia stem cells, addressing a significant unmet need in AML treatment.

Ryvu Therapeutics Advances Synthetic Lethality Pipeline with Promising Preclinical Data at AACR 2025

2 months ago

• Ryvu's RVU305, a brain-permeable MTA-cooperative PRMT5 inhibitor, demonstrates significant tumor growth inhibition in MTAP-deleted cancer models and enhances responses when combined with anti-PD-1 antibodies. • The company's proprietary ONCO Prime platform has identified novel synthetic lethal targets for KRAS-driven colorectal cancer, potentially offering new personalized treatment options for patients based on their tumor's genetic profile. • Ryvu is advancing multiple preclinical programs simultaneously, including next-generation ADC payloads that will be presented at the upcoming ADC Payload Summit in Boston, with IND/CTA-enabling studies for RVU305 on track for completion in H2 2025.

Over 220 Pipeline Therapies in Development for Non-Hodgkin's Lymphoma, Reports DelveInsight

2 months ago

• DelveInsight's 2025 pipeline report reveals more than 200 companies developing 220+ therapies for Non-Hodgkin's Lymphoma, demonstrating robust research activity in this therapeutic area. • Key investigational therapies include Mosunetuzumab (Roche), Tisagenlecleucel (Novartis), Capivasertib (AstraZeneca), BI-1206 (BioInvent), and HMPL-760 (Hutchmed), each employing distinct mechanisms of action. • Novel approaches include T-cell bispecific antibodies, CAR-T cell therapies, AKT inhibitors, and next-generation BTK inhibitors, addressing treatment resistance and improving outcomes for relapsed/refractory patients.

AbbVie Diversifies Portfolio with FDA Priority Review for Upadacitinib as Humira Faces Biosimilar Competition

3 months ago

• AbbVie's JAK1-selective inhibitor upadacitinib has received FDA Priority Review for moderate to severe rheumatoid arthritis, with potential annual sales projected to reach $3 billion. • The company is strategically expanding its portfolio as its blockbuster Humira faces biosimilar competition in Europe, with international sales already declining 15% despite continued growth in the US market. • Beyond upadacitinib, AbbVie's diversification strategy includes promising candidates like risankizumab for psoriasis and established cancer drugs Imbruvica and Venclexta, alongside recently approved Orilissa for endometriosis.

FDA Grants Orphan Drug Designation to Bexmarilimab for Myelodysplastic Syndrome Treatment

3 months ago

• Faron Pharmaceuticals' lead candidate bexmarilimab receives FDA Orphan Drug Designation for myelodysplastic syndromes treatment, offering development incentives and seven-year marketing exclusivity upon approval. • The novel immunotherapy targets the Clever-1 receptor on macrophages, reprogramming them from immunosuppressive to immunostimulatory states to enhance anti-tumor immune responses. • Top-line efficacy results for bexmarilimab in both frontline and HMA-failed MDS patients are expected to be reported in April 2025.

Emavusertib Shows Promise in FLT3-Mutated AML Patients Resistant to Prior Therapies

3 months ago

• Phase 1/2 TakeAim Leukemia trial demonstrates significant efficacy of emavusertib in relapsed/refractory AML patients, with 6 complete remissions observed among 19 evaluable FLT3-mutated patients. • The IRAK4 inhibitor showed effectiveness in patients previously treated with FLT3 inhibitors like midostaurin and gilteritinib, suggesting potential to overcome existing resistance mechanisms. • Clinical responses were also observed in patients with spliceosome factor mutations, including those heavily pretreated with hypomethylating agents plus venetoclax.

Brukinsa Demonstrates Superior Safety Profile Compared to Imbruvica in CLL Treatment Study

3 months ago

• A new study comparing BTK inhibitors in chronic lymphocytic leukemia treatment shows Brukinsa (zanubrutinib) had fewer severe side effects than Imbruvica (ibrutinib), with 4% versus 9% incidence respectively. • Notable findings include complete absence of neutropenia in the Brukinsa group compared to 3% in the Imbruvica group, suggesting particular benefits for older or immunocompromised patients. • Treatment discontinuation and dose reductions were less frequent with Brukinsa, though researchers emphasize the importance of personalized treatment decisions based on individual patient characteristics.

Tambiciclib-Zanubrutinib Combo Shows 67% Response Rate in Relapsed/Refractory DLBCL Trial

3 months ago

• Phase 2a trial demonstrates promising 67% overall response rate for tambiciclib plus zanubrutinib combination in relapsed/refractory DLBCL patients, including one complete response. • The combination therapy showed particularly strong efficacy in ABC DLBCL subtype patients, achieving an 83% disease control rate with 4 responses and 1 stable disease out of 6 patients. • Safety profile reveals grade 3 or higher adverse effects in 55.6% of patients, while genetic analysis indicates efficacy independent of MYD88 or CD79B mutations.

Novel Approaches Reshape Lymphoma Treatment Landscape: Bispecific Antibodies and MRD-Guided Therapy Show Promise

4 months ago

• Bispecific antibodies demonstrate remarkable response rates in both diffuse large B-cell and follicular lymphoma, with promising durability in frontline treatment settings. • Groundbreaking ECOG-ACRIN trial reveals MRD-negative mantle cell lymphoma patients may not require stem cell transplantation, potentially changing decades of standard practice. • Research initiatives are expanding to include older lymphoma patients and focus on quality-of-life outcomes, with new trial designs better reflecting real-world patient populations.

Ascentage Pharma's IPO Funds Global Expansion of Cancer Therapies

4 months ago

• Ascentage Pharma raised $126.4 million in a U.S. IPO to support late-stage clinical development of olverembatinib and lisaftoclax, aimed at treating CML and CLL, respectively. • Olverembatinib, already approved in China for CML, is undergoing Phase 3 trials in the U.S., Canada, Australia, and China, with plans for an FDA submission in 2026. • Lisaftoclax, a Bcl-2 inhibitor, is under regulatory review in China for advanced CLL/SLL, with potential to compete with AbbVie and Genentech's Venclexta. • Takeda Pharmaceuticals holds an option to license olverembatinib outside of Greater China and Russia, potentially bringing Ascentage up to $1.2 billion in milestone payments.

Survey Reveals Challenges in Venetoclax Adoption for CLL Treatment in Community Settings

4 months ago

• A recent survey of 103 oncologist-hematologists shows tumor lysis syndrome management and clinical logistics are primary concerns in venetoclax initiation for CLL treatment. • Only one-third of community physicians regularly prescribe fixed-duration venetoclax therapy, despite its potential cost advantages over indefinite BTK inhibitor treatment. • The AMPLIFY study investigating fixed-duration acalabrutinib-venetoclax combination shows promise as a potential new all-oral treatment option for frontline CLL therapy.

Acalabrutinib Receives FDA Approval for Previously Untreated Mantle Cell Lymphoma

4 months ago

• The FDA has granted traditional approval to acalabrutinib in combination with bendamustine and rituximab for untreated MCL patients ineligible for stem cell transplant. • The approval was based on the ECHO trial, which showed a 27% reduction in disease progression or death compared to chemoimmunotherapy alone. • Median progression-free survival was 66.4 months with acalabrutinib versus 49.6 months with chemoimmunotherapy, demonstrating a clinically significant improvement. • Acalabrutinib is now the first and only BTK inhibitor approved for first-line MCL treatment, offering a new option for this rare and aggressive cancer.

Oryzon's Iadademstat Enters Phase I Trial for Myelodysplastic Syndrome

4 months ago

• Oryzon Genomics has announced the dosing of the first patient in a Phase I trial of iadademstat for myelodysplastic syndrome (MDS). • The trial, led by the Medical College of Wisconsin, will assess the safety, tolerability, and optimal dose of iadademstat with azacitidine. • Iadademstat, a selective LSD1 inhibitor, aims to address the differentiation block in hematopoietic progenitor cells characteristic of MDS. • The study hopes to improve outcomes for MDS patients, where current treatments have limited efficacy, especially in higher-risk cases.

Aptose's Tuspetinib-Based Triple Therapy Shows Promise in Newly Diagnosed AML Patients

4 months ago

• Aptose Biosciences' TUSCANY trial evaluates tuspetinib (TUS) with venetoclax (VEN) and azacitidine (AZA) for newly diagnosed AML patients. • Early data from the trial's first cohort show complete remissions in patients with TP53 mutations and FLT3-wildtype AML. • The triplet therapy demonstrates a favorable safety profile, with no dose-limiting toxicities or prolonged myelosuppression observed. • The Cohort Safety Review Committee (CSRC) has approved dose escalation to 80 mg of tuspetinib based on the encouraging safety data.

Blinatumomab Approved for Consolidation Therapy in CD19-Positive B-ALL, Regardless of MRD Status

5 months ago

• The FDA approved blinatumomab in June 2024 for CD19-positive, Philadelphia chromosome-negative B-ALL consolidation, expanding its use in both adult and pediatric patients. • ECOG-ACRIN E1910 trial data supported the approval, showing superior overall survival with blinatumomab plus chemotherapy compared to chemotherapy alone. • Blinatumomab is now a standard component of consolidation therapy, irrespective of a patient's minimal residual disease (MRD) status or backbone chemotherapy. • Research continues to refine blinatumomab's role, exploring optimal patient selection, treatment sequencing, and the necessity of allogeneic stem cell transplant.

AbbVie's Telisotuzumab Vedotin Shows Promise in c-Met Overexpressing NSCLC

5 months ago

• AbbVie's telisotuzumab vedotin (Teliso-V) demonstrated a 35% overall response rate in patients with high c-Met expression in the LUMINOSITY trial. • The FDA granted breakthrough therapy designation to Teliso-V, highlighting its potential to significantly improve outcomes in NSCLC patients. • A phase 3 trial (TeliMET-NSCLC-01) is underway, comparing Teliso-V to docetaxel in c-Met-positive, non-squamous NSCLC patients. • Teliso-V targets c-Met, a protein involved in cancer progression and resistance to therapies like EGFR inhibitors, offering a novel approach.

Non-ABL1 Mutations Impact Outcomes in Chronic Myeloid Leukemia

5 months ago

• Analysis of CML patients reveals that non-ABL1 mutations, such as ASXL1 and RUNX1, can influence disease progression and treatment response. • The study used next-generation sequencing to assess the impact of these mutations on overall survival, event-free survival, and failure-free survival in CML patients. • Findings suggest that identifying non-ABL1 mutations could help personalize treatment strategies and improve long-term outcomes for CML patients. • The research highlights the importance of continuous monitoring and understanding of factors affecting treatment outcomes in CML.

Novel Regimens Show Promise in CLL/SLL Treatment, Offering Durable Remissions and Improved Outcomes

5 months ago

• Fixed-duration ibrutinib and venetoclax demonstrate durable progression-free survival in CLL/SLL, even in high-risk patients, offering an easy-to-administer, all-oral option. • Zanubrutinib and venetoclax combination shows high efficacy in relapsed/refractory CLL, including those with prior BTK or BCL2 inhibitor exposure, with manageable tolerability. • Zanubrutinib monotherapy demonstrates superior progression-free survival compared to bendamustine/rituximab in treatment-naive CLL/SLL patients without del(17p) after 5-year follow-up. • Time-limited zanubrutinib/rituximab therapy induces durable remissions in treatment-naive CLL, suggesting a potential alternative to long-term BTK inhibitor monotherapy.

Drug Development Updates