Clinical Trial News
FDA Issues Safety Alert on Unapproved Robot-Assisted Mastectomy Procedures
• The FDA has released a safety communication warning against the use of robot-assisted surgical devices for mastectomy procedures, citing lack of established safety and efficacy data.
• Clinical trials using robotic surgery for breast cancer prevention and treatment are being conducted without proper FDA oversight and required investigational device exemptions.
• While robot-assisted surgery offers benefits like smaller incisions and faster recovery, the FDA demands rigorous long-term outcome data for cancer-related procedures, including survival and recurrence rates.
Ponatinib Dose-Ranging Study Shows Efficacy in Chronic-Phase CML Patients
A phase 2 trial evaluating ponatinib in chronic-phase chronic myeloid leukemia (CP-CML) patients resistant to prior tyrosine kinase inhibitors (TKIs) demonstrated significant efficacy across three starting doses. The study highlighted a novel, response-based dose-reduction strategy, with the 45 mg starting dose showing optimal benefit/risk outcomes when reduced to 15 mg upon achieving a response.
Highlighted Clinical Trials:
Cardio-Oncology: Balancing Breast Cancer Treatment with Heart Health
• Breast cancer treatments like doxorubicin and trastuzumab can impair heart function, leading to complications like heart failure, necessitating careful cardiovascular monitoring.
• Shared risk factors between breast cancer and heart disease, including age, obesity, and lifestyle, highlight the importance of preventative measures for both conditions.
• Cardio-oncology emerges as a specialty to integrate cardiac care with cancer treatment, emphasizing multidisciplinary approaches to minimize cardiac risks during cancer therapy.
• Research indicates that lifestyle interventions, such as regular exercise, and medications like statins may protect heart health during breast cancer treatment, improving overall outcomes.
UCB Announces U.S. FDA Approvals for BIMZELX® (bimekizumab-bkzx) for the Treatment of Psoriatic Arthritis, Non-Radiographic Axial Spondyloarthritis, and Ankylosing Spondylitis
UCB has received U.S. FDA approval for BIMZELX® (bimekizumab-bkzx) to treat adults with active psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA), and ankylosing spondylitis (AS). BIMZELX is the first IL-17A and IL-17F inhibitor approved in the U.S. for these conditions, supported by Phase 3 studies showing significant improvements in symptoms.
Seagen Secures $2.6B Deal with RemeGen for Novel HER2-Targeting Cancer Drug
• Seagen has acquired ex-Asian rights to RemeGen's disitamab vedotin for $200 million upfront, with potential payments of $2.4 billion, targeting HER2-positive cancers including breast, bladder, and gastric tumors.
• The antibody-drug conjugate has already received conditional approval in China for HER2-positive gastric cancer and breakthrough designation from FDA for bladder cancer.
• The deal positions Seagen to compete with established HER2-targeting ADCs like AstraZeneca/Daiichi Sankyo's Enhertu and Roche's Kadcyla, while focusing initially on distinct market segments.
Triple Immunotherapy Eradicates Pancreatic Tumors in Mice, Clinical Trials Expected
• A novel triple-drug immunotherapy combination has demonstrated the ability to eliminate pancreatic tumors in mice, offering a promising new approach for this deadly disease.
• The therapy combines inhibitors of PD-1 and TIGIT with a CD40 agonist antibody to rejuvenate exhausted T cells and stimulate an immune attack on tumor cells.
• Analysis of human pancreatic tumors revealed high expression of CD155, which activates the TIGIT receptor on T cells, leading to T cell exhaustion and suppressed immune response.
• Clinical trials are expected to begin later this year to evaluate the triple combination in pancreatic cancer patients, potentially offering a new treatment option.
Watchdog to Review FDA's Approval Process for Biogen's Alzheimer's Drug
The Department of Health and Human Services' Office of Inspector General will review the FDA's accelerated approval process for Biogen's Alzheimer's drug, Aduhelm, following controversy over regulatory standards and the drug's efficacy.
Luye Pharma's Next-Generation VMAT2 Inhibitor LY03015 to Begin Clinical Trials in the U.S.
Luye Pharma Group has announced the submission of an investigational new drug application for its next-generation VMAT2 inhibitor, LY03015, in the U.S., with Phase I clinical trials expected to start soon. LY03015 is designed for treating tardive dyskinesia (TD) and Huntington's disease (HD), offering potential improvements over current treatments in terms of efficacy, safety, and pharmacokinetic properties.
FDA Grants First-Ever Breakthrough Device Status to Digital Therapeutic for Heart Failure Management
• Biofourmis' BiovitalsHF becomes the first digital therapeutic to receive FDA breakthrough device designation, marking a significant milestone in digital health innovation for heart failure treatment.
• The prescription digital therapeutic uses wearable sensors and algorithms to optimize guideline-directed medical therapy for patients with heart failure with reduced ejection fraction (HFrEF).
• Clinical data demonstrates BiovitalsHF improves medication adherence and health outcomes, addressing a critical need as less than 1% of heart failure patients currently receive optimal drug dosing.
Ascentage Pharma Announces Milestone Payment from UNITY Biotechnology for Senolytic Drug Candidate UBX1325
Ascentage Pharma has announced a milestone payment from UNITY Biotechnology following encouraging Phase I clinical study results for UBX1325, a senolytic drug candidate targeting advanced vascular eye diseases. The drug, developed from Ascentage Pharma's licensed compound BM-962, has shown rapid improvement in patients with diabetic macular edema or wet age-related macular degeneration, leading to the initiation of a Phase IIa clinical study.