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Clinical Trial News

FDA Approves BridgeBio's Attruby (acoramidis) for ATTR-CM Treatment

• The FDA has approved BridgeBio Pharma's Attruby (acoramidis) for treating transthyretin amyloid cardiomyopathy (ATTR-CM) in adults, marking a significant advancement in cardiac care. • Attruby, an oral transthyretin (TTR) stabilizer, is the first approved product with a label specifying near-complete TTR stabilization, reducing cardiovascular deaths and hospitalizations. • The approval was based on the Phase III ATTRibute-CM trial, which demonstrated a win ratio of 1.8 and significant improvements in the six-minute walk test and NT-proBNP levels. • BridgeBio plans to pursue global approvals and provide Attruby free for life to US trial participants, with Bayer holding exclusive commercialization rights in Europe.

FDA Accepts GSK's Blenrep Combination Therapy for Relapsed/Refractory Multiple Myeloma

  • The FDA has accepted GSK's biologics license application for Blenrep in combination with BorDex and PomDex.
  • This combination therapy targets patients with relapsed or refractory multiple myeloma who have undergone at least one prior line of therapy.
  • The FDA's decision is expected by July 23, with the application based on positive results from the DREAMM-7 and DREAMM-8 phase III trials.
  • Multiple myeloma is the third most common type of blood cancer, with a need for new therapies due to resistance to available treatments.

Care Bundles Improve Enteral Nutrition Management in Stroke Patients: A Multi-Center Trial

  • A multi-center, stepped-wedge, cluster-based randomized controlled trial is underway to evaluate care bundles for enteral nutrition in stroke patients.
  • The primary hypothesis is that these care bundles will reduce feeding intolerance, a common and serious complication in stroke patients requiring nutritional support.
  • Secondary hypotheses include reduced complications, improved nutritional status, and better overall recovery for stroke patients receiving the intervention.
  • The trial involves eight hospitals in China, with a target sample size of 1224 patients, aiming to demonstrate the effectiveness of standardized enteral nutrition protocols.

FDA to Review Belantamab Mafodotin and Linvoseltamab Combinations for Multiple Myeloma

  • The FDA has accepted a BLA for belantamab mafodotin combinations with bortezomib plus dexamethasone and pomalidomide plus dexamethasone for multiple myeloma treatment.
  • Regeneron's linvoseltamab BLA resubmission has been accepted by the FDA, with a decision expected by July 10, 2025, for relapsed/refractory multiple myeloma.
  • Clinical trials DREAMM-7 and DREAMM-8 support the belantamab mafodotin BLA, while LINKER-MM1 supports the linvoseltamab BLA, showcasing improved progression-free survival.
  • Both belantamab mafodotin and linvoseltamab are under review by other regulatory authorities, potentially expanding treatment options for multiple myeloma patients.

Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

NCT04246047Active, Not RecruitingPhase 3
GlaxoSmithKline
Posted 5/7/2020

Study to Investigate the Safety and Tolerability of Odronextamab in Patients With CD20+ B-Cell Malignancies

NCT02290951Active, Not RecruitingPhase 1
Regeneron Pharmaceuticals
Posted 1/9/2015

Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma

NCT04484623Active, Not RecruitingPhase 3
GlaxoSmithKline
Posted 10/1/2020

A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Patients With Multiple Myeloma That is Resistant to Current Standard of Care Treatments

NCT05137054RecruitingPhase 1
Regeneron Pharmaceuticals
Posted 8/17/2022

Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

NCT04501666CompletedPhase 3
Galderma R&D
Posted 9/11/2020

A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Adult Patients With B-cell Non-Hodgkin Lymphoma Who Have Been Previously Treated With Other Cancer Therapies

NCT03888105RecruitingPhase 2
Regeneron Pharmaceuticals
Posted 11/13/2019

A Trial to Learn if Odronextamab Combined With Chemotherapy is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Chemotherapy for Adult Participants With Follicular Lymphoma

NCT06097364RecruitingPhase 3
Regeneron Pharmaceuticals
Posted 11/14/2023

A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Participants With Follicular Lymphoma

NCT06091254RecruitingPhase 3
Regeneron Pharmaceuticals
Posted 12/12/2023

A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma

NCT05730036RecruitingPhase 3
Regeneron Pharmaceuticals
Posted 9/18/2023

Phase 1/2 Study of REGN5458 in Adult Patients With Relapsed or Refractory Multiple Myeloma

NCT03761108RecruitingPhase 1
Regeneron Pharmaceuticals
Posted 1/23/2019

Injectable Oxygen Microbubbles Show Promise in Treating Hypoxemia and Preventing Organ Damage

  • Researchers have developed injectable oxygen microbubbles for rapid oxygen delivery during critical moments of cardiac or respiratory arrest, addressing the limitations of traditional methods.
  • In preclinical testing, pH-sensitive microbubbles delivered precise amounts of oxygen, significantly improving survival and preventing catastrophic organ damage in hypoxemic conditions.
  • The microbubbles are engineered with a solid-like polymer shell that dissolves into tiny soluble molecules when triggered by blood pH, ensuring rapid dissolution and preventing blood-flow obstruction.
  • This innovative approach represents a potential platform technology for delivering various gases in focused amounts, opening possibilities for treating other medical conditions beyond hypoxemia.

Novartis' Scemblix Shows Promising 96-Week Data in First-Line CML Treatment

• Scemblix (asciminib) demonstrates favorable safety and tolerability compared to investigator-selected TKIs in newly diagnosed CML-CP patients. • The ASC4FIRST Phase III study's 96-week results support Scemblix as a potential first-line treatment option for chronic myeloid leukemia. • Novartis is presenting over 65 abstracts at ASH and SABCS, highlighting their commitment to cancer and blood disorder research.

FDA Approves Roche's PATHWAY HER2 Test as Companion Diagnostic for HER2-Positive Biliary Tract Cancer

• The FDA has approved Roche's PATHWAY HER2 (4B5) test to identify biliary tract cancer (BTC) patients eligible for ZIIHERA, a HER2-targeted therapy. • This marks the first FDA-approved companion diagnostic for HER2 status assessment in BTC, addressing a critical gap in personalized medicine for this cancer. • Biliary tract cancer has a poor prognosis due to late diagnosis and limited treatment options, making this approval a significant step forward. • The PATHWAY HER2 test expands its clinical utility, previously used for breast cancer, to now guide HER2-targeted therapy in BTC patients.

FDA Approves BridgeBio's Attruby, Setting Up Competition with Pfizer's Vyndamax in ATTR-CM Market

• The FDA has approved BridgeBio Pharma's Attruby (acoramidis) for transthyretin amyloidosis cardiomyopathy (ATTR-CM), a heart condition leading to heart failure and death. • Attruby demonstrated a 42% reduction in composite all-cause mortality and recurrent cardiovascular-related hospitalizations compared to placebo in the ATTRibute-CM trial. • BridgeBio is launching Attruby at a list price of $18,759 for a 28-day supply, positioning it to compete with Pfizer's Vyndamax, which dominates the ATTR-CM market. • Several other companies, including Alnylam and AstraZeneca/Ionis, are also developing therapies for ATTR, potentially disrupting the current treatment landscape.

Decitabine Plus CHAG Regimen Shows Promise in Relapsed/Refractory AML

  • A study shows that combining decitabine with the CHAG priming regimen yields a high complete remission rate (74.2%) in relapsed/refractory AML patients.
  • The overall response rate was 82.2%, with manageable side effects and no treatment-related deaths, suggesting a potential new treatment strategy.
  • The median relapse-free survival was 4.3 months, and the median overall survival was 7.75 months, warranting further investigation with larger studies.
  • Decitabine combined with CHAG may offer deeper remissions, with a significant number of patients achieving MRD-negative status after treatment.

AstraZeneca's Prostate Cancer Drug Demonstrates Promising Phase III Results

  • AstraZeneca's prostate cancer drug has shown promising Phase III results, indicating a potential advancement in treatment.
  • The drug's efficacy could significantly impact the management of prostate cancer, offering new hope for patients.
  • Further details on the specific outcomes and benefits are anticipated to be released, pending comprehensive data analysis.
  • The positive results may lead to changes in treatment protocols and improved patient outcomes in the future.

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