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FDA Approves Foresee's CAMCEVI ETM 21mg for Advanced Prostate Cancer Treatment

Drug ApprovalOncology
  • The FDA has approved CAMCEVI ETM (leuprolide mesylate 21 mg), a ready-to-use long-acting injectable formulation administered every 3 months for advanced prostate cancer treatment.
  • The approval was based on a successful Phase 3 clinical study with 144 advanced prostate cancer patients, demonstrating 97.9% of subjects achieved the primary efficacy endpoint.
  • CAMCEVI ETM is exclusively licensed to Accord BioPharma for U.S. commercialization, with commercial launch expected after obtaining a J-code.
  • This represents Foresee Pharmaceuticals' second FDA-approved prostate cancer treatment, following CAMCEVI 42 mg which launched in April 2022.

A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)

NCT05118789RecruitingPhase 1
Nuvalent Inc.
Posted 1/4/2022

Study of RP-6306 With Gemcitabine in Advanced Solid Tumors

NCT05147272TerminatedPhase 1
Repare Therapeutics
Posted 12/16/2021

A Study of Osimertinib With or Without Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer (FLAURA2)

NCT04035486Active, Not RecruitingPhase 3
AstraZeneca
Posted 7/2/2019

Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer

NCT03155997Active, Not RecruitingPhase 3
Eli Lilly and Company
Posted 7/12/2017

Study of PDS0101 and Pembrolizumab Combination I/O in Subjects With HPV16 + Recurrent and/or Metastatic HNSCC

NCT04260126CompletedPhase 2
PDS Biotechnology Corp.
Posted 3/29/2021

Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate (LMIS 25 mg) in Subjects With Prostate Cancer

NCT03261999CompletedPhase 3
Foresee Pharmaceuticals Co., Ltd.
Posted 9/26/2017

Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

NCT05280470Active, Not RecruitingPhase 2
Daiichi Sankyo
Posted 3/9/2022

Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)

NCT05501886RecruitingPhase 3
Celcuity Inc
Posted 12/8/2022

Gastric Cancer Pipeline Shows Robust Growth with 220+ Therapies in Development Across 200+ Companies

Monoclonal AntibodyOncology
  • DelveInsight's 2025 pipeline report reveals over 200 companies developing 220+ therapeutic candidates for gastric cancer treatment across all clinical stages.
  • Recent clinical developments include Bold Therapeutics' Phase 1b/2a study of BOLD-100 with FOLFOX chemotherapy and Jazz Pharmaceuticals' zanidatamab combination trials.
  • Leading pipeline candidates include tislelizumab (BeiGene), catumaxomab (Linton Pharm), and tivumecirnon (RAPT Therapeutics) targeting various mechanisms from PD-1 inhibition to regulatory T cell migration.
  • The pipeline encompasses diverse therapeutic approaches including monoclonal antibodies, small molecules, and combination therapies targeting novel mechanisms like Claudin 18.2 and DKK1 signaling.

Exelixis Closes Pennsylvania Facility, Cuts 130 Jobs in Strategic Consolidation

Oncology
  • Exelixis will close its King of Prussia, Pennsylvania facility and lay off 130 employees, representing an 11% workforce reduction as the company consolidates operations in California.
  • The closure eliminates Exelixis' entire presence in the Philadelphia region less than three years after expanding eastward, reflecting broader biotech industry cost-cutting trends.
  • The restructuring comes as Exelixis focuses resources on advancing zanzalintinib, which showed positive Phase III results when combined with Tecentriq for metastatic colorectal cancer.
  • The move highlights pipeline pressures as Exelixis faces looming patent expirations for its blockbuster drug Cabometyx, which generated $1.81 billion of the company's $2.17 billion revenue in 2024.

Celltrion Expands Biosimilar Portfolio in Vietnam's $7.3 Billion Biopharmaceutical Market

Oncology
  • Celltrion launched two biosimilars in Vietnam in 2024, including Remsima for autoimmune diseases and Herzuma for breast and stomach cancer.
  • The company aims to obtain Vietnamese approval for two additional biosimilars later this year: Remsima SC and Truxima for blood cancer treatment.
  • Vietnam's biopharmaceutical market reached $7.3 billion in 2023 with over 7% annual growth, driving increased demand for biosimilar therapies.
  • Celltrion plans to commercialize 22 biosimilars by 2030 and achieve 5 trillion won in annual sales by 2025.

Lilly's Verzenio Demonstrates Significant Overall Survival Benefit in High-Risk Early Breast Cancer

Oncology
  • Eli Lilly's Verzenio plus endocrine therapy demonstrated statistically significant and clinically meaningful improvement in overall survival compared to endocrine therapy alone in patients with HR+, HER2-, node-positive, high-risk early breast cancer.
  • The seven-year landmark analysis of the monarchE trial also showed sustained benefit in invasive disease-free survival and distant relapse-free survival, reinforcing the consistency and durability of treatment effects.
  • These results validate Verzenio as the standard-of-care for patients with node-positive, high-risk disease and represent a major milestone for CDK4/6 inhibitor therapy in the adjuvant setting.
  • The monarchE study enrolled 5,637 adults across more than 600 sites in 38 countries, making it the only adjuvant study designed specifically to investigate a CDK4/6 inhibitor in a node-positive, high-risk early breast cancer population.

Wugen Secures $115 Million to Advance First-in-Class Off-the-Shelf CAR-T Therapy for T-Cell Malignancies

CAR-TOncology
  • Wugen raised $115 million in financing led by Fidelity Management & Research to advance its pivotal T-RRex trial of WU-CART-007, an off-the-shelf CAR-T therapy for relapsed/refractory T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma.
  • WU-CART-007 demonstrated exceptional efficacy in Phase 1/2 trials with a 91% overall response rate and 73% complete remission rate, substantially outperforming current standard-of-care therapies for these aggressive malignancies.
  • The company aims to file a Biologics License Application in 2027, positioning WU-CART-007 as the potential first approved allogeneic CAR-T therapy for T-cell malignancies.
  • The therapy uses CRISPR gene editing technology and donor-derived cells to create an accessible, scalable treatment that eliminates the need for patient-specific cell extraction and manipulation.

A Phase 1 Study of of Anti-CD7 Allogeneic CAR-T Cell Therapy (WU-CART-007) in Patients With Relapsed or Refractory T-ALL/LBL

NCT04984356CompletedPhase 1
Wugen, Inc.
Posted 1/14/2022

A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy in T-Cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma (T-RRex)

NCT06514794RecruitingPhase 2
Wugen, Inc.
Posted 1/31/2025

Starpharma Advances Dendrimer Drug Delivery Platform with Genentech Partnership and Clinical Progress

Oncology
  • Starpharma's DEP platform has treated over 350 patients in clinical trials, with DEP SN38 receiving positive FDA feedback for potential Fast Track designation in platinum-resistant ovarian cancer.
  • The company secured an $8.3 million upfront payment from Genentech in a collaboration worth up to $855 million in milestone payments for developing dendrimer drug conjugates.
  • Commercial products VivaGel BV and Viraleze continue expanding globally, with VivaGel now registered in over 40 countries and Viraleze achieving 40% online sales growth.
  • Despite revenue declining to $5.9 million from $9.8 million year-over-year, the company maintains $15.4 million in cash reserves while advancing radiotheranostics programs toward 2026 clinical trials.

Er-Kim Secures Exclusive Distribution Rights for CNX Therapeutics' Oncology Portfolio in Central & Eastern Europe and Turkey

Oncology
  • Er-Kim, an international pharmaceutical company with 40+ years of experience in emerging EMEA markets, has signed an exclusive distribution agreement with CNX Therapeutics for oncology products across Central & Eastern Europe and Turkey.
  • The partnership will expand access to CNX's established oncology portfolio, including Cardioxane (dexrazoxane) and Savene (dexrazoxane), across all CEE markets through Er-Kim's extensive regional distribution network.
  • This strategic collaboration leverages Er-Kim's proven track record of distributing 68+ products to 50+ countries with revenues exceeding EUR 305M, positioning both companies to enhance cancer patient access in underserved regions.

Charles River Laboratories Joins EU-Backed EASYGEN Consortium to Accelerate Bedside CAR-T Manufacturing

CAR-TOncology
  • Charles River Laboratories has joined the EASYGEN Consortium, a European Union-backed initiative aimed at developing fully automated, hospital-based CAR-T cell therapy manufacturing within 24 hours.
  • The company will leverage its 3D screening technologies and patient-derived xenograft bank to create an ex vivo platform for rapid safety and efficacy screening of CAR-T cell candidates.
  • Currently, fewer than 20 percent of eligible patients receive CAR-T therapy due to complex, time-intensive manufacturing processes and limited capacity at specialized facilities.
  • The five-year research project involves 18 academic, research, industry and clinical partners across eight countries, targeting reduced costs and expanded patient access to personalized cell therapies.

EMA Grants First-Ever Orphan Drug Designation for Radiation Maculopathy Treatment

Rare DiseaseOncology
  • The European Medicines Agency has granted orphan drug designation to Roca Therapeutics' RCT002, marking the first formal recognition of radiation maculopathy as a distinct medical indication.
  • RCT002 is a first-in-class eye drop therapy designed to address resistant neovascularization, inflammation, fibrosis, and oxidative stress in patients experiencing vision loss after radiotherapy.
  • The designation opens pathways for accelerated regulatory support and targeted therapeutic development for a condition that currently has no approved treatment options.
  • Roca Therapeutics plans to initiate first-in-human clinical trials for RCT002 in 2026 while currently fundraising to support the program.

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