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Sandoz Receives FDA Approval for First Denosumab Biosimilars in US and Canada

Monoclonal AntibodyDrug ApprovalOncology
  • Sandoz received FDA approval for Jubbonti and Wyost, the first and only denosumab biosimilars approved in the United States and Canada, marking a significant milestone in biosimilar development.
  • The biosimilars are approved as interchangeable with Amgen's reference medicines Prolia and Xgeva for all indications, including osteoporosis treatment and prevention of cancer-related bone complications.
  • More than 10 million US adults aged 50 and over live with osteoporosis, with half of all women over 50 experiencing an osteoporotic fracture during their lifetime.
  • The approvals are based on robust phase I and phase III clinical studies demonstrating no clinically meaningful differences from the reference medicines.

Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis

NCT03974100CompletedPhase 3
Sandoz
Posted 7/2/2019

Pharmaceutical Industry Leadership Shuffle: Major Executive Appointments Signal Strategic Shifts Across Biotech and Pharma

CAR-TOncologyFDA Approval
  • AbbVie promoted long-time COO Robert Michael to CEO, marking the end of an extensive leadership search with an internal succession plan.
  • Multiple European biotechs appointed new CEOs, including OneChain Immunotherapeutics, Maxion Therapeutics, and StromaCare, reflecting strategic pivots in cancer immunotherapy development.
  • Astellas created its first chief digital and transformation officer role, signaling the pharmaceutical industry's increasing focus on digital transformation initiatives.
  • Acumen Pharmaceuticals strengthened its Alzheimer's drug development capabilities by appointing James Doherty, a neuroscience veteran with two FDA approvals under his belt.

Biovica Signs Master Service Agreement to Support Next-Generation CDK4/6 Inhibitor Development for Breast Cancer

Oncology
• Biovica International has secured a master service agreement with a biopharmaceutical company to provide TKa testing services for evaluating cell proliferation in drug development studies, with an initial work order valued at 1.2 MSEK.
• The agreement enables Biovica to contribute to the development of first-in-class next-generation CDK4/6 inhibitor therapeutics for breast cancer, potentially leading to a Companion Diagnostic product.
• This partnership adds to Biovica's existing portfolio of 13 master service agreements with pharmaceutical and biotech companies, highlighting growing industry demand for their blood-based cancer monitoring technology.

Promontory Therapeutics Completes Enrollment in Phase 2 Trial of PT-112 for Late-Stage Metastatic Prostate Cancer

Oncology
  • Promontory Therapeutics has completed enrollment of 109 patients in its Phase 2 trial of PT-112 for metastatic castration-resistant prostate cancer (mCRPC) across 32 clinical sites in the US and France.
  • PT-112, the first small-molecule conjugate of pyrophosphate in clinical oncology development, works by inhibiting ribosomal biogenesis to induce immunogenic cell death in "immune-cold" prostate cancer.
  • The study targets heavily pre-treated patients who have received at least three prior therapies, with topline safety and efficacy results expected in late 2024 following planned FDA meetings.

A Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-112 Injection in Subjects With Advanced Solid Tumors and Subsequent Dose Expansion Cohorts

NCT02266745Active, Not RecruitingPhase 2
Promontory Therapeutics Inc.
Posted 7/1/2014

India's Indigenous CAR T-Cell Therapy Revolutionizes Cancer Treatment at One-Tenth Global Cost

CAR-TOncologyDrug Approval
  • India has successfully developed NexCAR19, its first indigenous CAR T-cell therapy for blood cancers, priced at approximately Rs 40 lakh ($50,000) compared to $400,000 in the United States.
  • Clinical trials involving 64 patients with advanced lymphoma or leukemia showed promising results, with 67% experiencing significant cancer reduction and about half achieving complete remission.
  • Unlike U.S. approved therapies that use mouse-derived antibody fragments, India's "humanized" CAR T-cells caused fewer severe side effects, with no reported neurologic complications and only 5% experiencing severe cytokine release syndrome.

FDA Grants Orphan Drug Designation to Tigilanol Tiglate for Soft Tissue Sarcoma Treatment

Rare DiseaseOncology
  • The FDA has awarded orphan drug designation to tigilanol tiglate (Stelfonta), an intratumoral injection, for treating soft tissue sarcoma, a rare cancer affecting both adults and children.
  • The designation provides QBiotics with important regulatory incentives including tax credits, user fee exemptions, and potential seven years of market exclusivity following approval.
  • Tigilanol tiglate is currently being evaluated in a phase 2 trial at Memorial Sloan Kettering Cancer Center, with preliminary phase 1 data showing responses in 6 of 22 patients.
  • Soft tissue sarcomas comprise more than 80 subtypes with unfavorable prognosis in advanced stages, highlighting the urgent need for new treatment options in this rare disease area.

A Clinical Study to Investigate the Efficacy of Intratumoral Tigilanol Tiglate in Soft Tissue Sarcoma

NCT05755113RecruitingPhase 2
QBiotics Group Limited
Posted 4/13/2023

Bispecific Antibodies: Promising Advances Amid Adoption Challenges in Cancer Treatment

Drug ApprovalOncologyCAR-TMonoclonal Antibody
  • Bispecific antibodies represent a significant advancement in cancer immunotherapy, targeting both tumor antigens and immune cells to enhance cytotoxicity without requiring patient-derived cells like CAR-T therapy.
  • Despite clinical promise with nine FDA-approved bispecific antibodies, adoption faces challenges including transition between inpatient/outpatient settings, insurance coverage, adverse event management, and financial barriers in community settings.
  • Recent approvals of Mosunetuzumab, Glofitamab, and Epcoritamab have shown impressive response rates in relapsed/refractory indolent B-cell lymphomas, with manageable toxicity profiles when using step-up dosing strategies.

Mosunetuzumab With or Without Polatuzumab Vedotin and Obinutuzumab for the Treatment of Untreated Indolent B-Cell Non-Hodgkin Lymphoma

NCT05169658CompletedPhase 2
University of Washington
Posted 3/23/2022

A Study Evaluating the Efficacy and Safety of Mosunetuzumab in Combination With Lenalidomide in Comparison to Rituximab in Combination With Lenalidomide With a US Extension of Mosunetuzumab in Combination With Lenalidomide in Participants With Follicular Lymphoma

NCT04712097Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 10/27/2021

Signatures of Response and Resistance to Mosunetuzomab in Follicular Lymphomas (FL)

NCT05529524Completed
The Lymphoma Academic Research Organisation
Posted 11/7/2022

Glofit and Obin in Follicular Lymphoma and Marginal Zone Lymphoma

NCT05783596RecruitingPhase 2
Reid Merryman, MD
Posted 7/18/2023

Mosunetuzumab-Lenalidomide Versus Investigator Choices in Patients With Relapsed or Refractory Marginal Zone Lymphoma

NCT06006117RecruitingPhase 3
The Lymphoma Academic Research Organisation
Posted 9/5/2023

Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma

NCT05409066Active, Not RecruitingPhase 3
Genmab
Posted 9/20/2022

CAR-T Followed by Bispecific Antibodies

NCT04889716RecruitingPhase 2
Abramson Cancer Center at Penn Medicine
Posted 11/5/2021

Tazemetostat and Mosunetuzumab in Untreated Follicular Lymphoma

NCT05994235RecruitingPhase 2
Weill Medical College of Cornell University
Posted 11/1/2023

Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)

NCT04663347Active, Not RecruitingPhase 1
Genmab
Posted 11/3/2020

Clarity's 64Cu-SAR-bisPSMA Shows Promise in Detecting Prostate Cancer Recurrence in COBRA Trial

Oncology
  • Initial results from Clarity Pharmaceuticals' Phase 1/2 COBRA trial demonstrate that 64Cu-SAR-bisPSMA safely and effectively detects prostate cancer lesions in patients with biochemical recurrence who had negative standard-of-care imaging.
  • The novel radiopharmaceutical identified lesions in up to 80% of patients on next-day imaging, with the number of detected lesions almost doubling compared to same-day imaging, highlighting a unique benefit of copper-64's longer half-life.
  • Clinicians reported they would change treatment plans for approximately 50% of patients based on 64Cu-SAR-bisPSMA scan results, with two-thirds of these patients subsequently receiving focal or systemic therapy.

64Cu-SAR-bisPSMA for Identification of Participants With Recurrence of Prostate Cancer (COBRA)

NCT05249127CompletedPhase 1
Clarity Pharmaceuticals Ltd
Posted 4/11/2022

64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants With Biochemical Recurrence of Prostate Cancer

NCT06970847RecruitingPhase 3
Clarity Pharmaceuticals Ltd
Posted 5/16/2025

Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy

NCT06056830RecruitingPhase 3
Clarity Pharmaceuticals Ltd
Posted 12/21/2023

Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer

NCT03732820Active, Not RecruitingPhase 3
AstraZeneca
Posted 10/31/2018

Positron Emission Tomography (PET) Imaging of Participants With Confirmed Prostate Cancer Using 64Cu-SAR-bisPSMA (PROPELLER)

NCT04839367CompletedPhase 1
Clarity Pharmaceuticals Ltd
Posted 7/13/2021

Kisqali Shows Enhanced Efficacy in Younger Breast Cancer Patients with 33% Risk Reduction

Oncology
  • Novartis' NATALEE trial subgroup analysis reveals Kisqali plus endocrine therapy reduced invasive disease risk by 33% in pre-menopausal early breast cancer patients at 44.2 months median follow-up.
  • Pre-menopausal and younger patients experienced greater risk reductions and fewer treatment discontinuations due to adverse events compared to post-menopausal patients.
  • A separate real-world analysis highlighted significant treatment disparities, showing Black patients with early breast cancer had worse outcomes despite meeting NATALEE eligibility criteria.
  • The findings underscore the importance of CDK4/6 inhibitor therapy for vulnerable populations, including younger and Black patients who face more aggressive disease characteristics.

A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer

NCT03701334Active, Not RecruitingPhase 3
Novartis Pharmaceuticals
Posted 12/7/2018

Dostarlimab Shows Superior Survival Outcomes Across Multiple Endometrial Cancer Molecular Subgroups in Phase 3 RUBY Trial

Oncology
  • The phase 3 RUBY trial demonstrated that dostarlimab combined with carboplatin and paclitaxel significantly improved progression-free survival and overall survival in patients with advanced or recurrent endometrial cancer across multiple molecular subgroups.
  • Patients with dMMR/MSI-H tumors showed the most dramatic benefit, with progression-free survival rates of 57.0% versus 10.2% in the placebo arm and overall survival rates of 83.3% versus 58.7%.
  • The TP53 mutation subgroup also demonstrated significant clinical benefit, with progression-free survival rates of 32.4% versus 17.8% and overall survival rates of 70.8% versus 33.2% in the placebo arm.
  • These findings support dostarlimab plus carboplatin/paclitaxel as a new standard of care for patients with newly diagnosed primary advanced or recurrent endometrial cancer.

Study of TSR-042, an Anti-programmed Cell Death-1 Receptor (PD-1) Monoclonal Antibody, in Participants With Advanced Solid Tumors

NCT02715284RecruitingPhase 1
Tesaro, Inc.
Posted 3/7/2016

A Study to Evaluate Dostarlimab Plus Carboplatin-paclitaxel Versus Placebo Plus Carboplatin-paclitaxel in Participants With Recurrent or Primary Advanced Endometrial Cancer

NCT03981796Active, Not RecruitingPhase 3
Tesaro, Inc.
Posted 7/15/2019

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