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Study Reveals Most Cancer Drugs with Accelerated FDA Approval Fail to Demonstrate Clinical Benefit After Five Years

Drug ApprovalOncology
  • A new study found that only 43% of cancer drugs granted FDA accelerated approval between 2013-2017 demonstrated clinical benefit in confirmatory trials after more than five years of follow-up.
  • Despite limited evidence of clinical benefit, 63% of these accelerated approval drugs were converted to regular approval, raising concerns about regulatory standards and patient communication.
  • The research highlights the need for better validation of surrogate endpoints and more robust evidence requirements before converting accelerated approvals to regular approvals.
  • Researchers emphasize the importance of clearer communication between physicians and patients about the uncertainty surrounding drugs approved on preliminary measures.

A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia

NCT02130557CompletedPhase 3
Pfizer
Posted 7/15/2014

Open Label Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL

NCT02399085CompletedPhase 2
MorphoSys AG
Posted 3/29/2016

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

FDA Clears Sequel's twiist AID System, First Insulin Pump to Directly Measure Every Micro-Dose

Drug Approval
  • The FDA granted 510(k) clearance to Sequel Med Tech's twiist automated insulin delivery system for type 1 diabetes patients aged 6 years and older on March 18, 2024.
  • The twiist system represents the first drug delivery device capable of directly measuring the volume and flow of insulin delivered with every micro-dose, powered by Tidepool Loop technology.
  • Developed by Dean Kamen, inventor of the first insulin pump, the system aims to provide more precise insulin delivery and expanded patient choice in diabetes management.
  • The device leverages Tidepool Loop algorithm to automatically adjust insulin delivery based on continuous glucose monitor readings and predicted glucose values.

Nivolumab Shows Consistent Benefit in Resectable NSCLC Regardless of Neoadjuvant Treatment Duration

Drug Approval
  • An exploratory analysis of the CheckMate 77T trial demonstrates that perioperative nivolumab plus chemotherapy improves pathological complete response rates in resectable NSCLC patients, regardless of whether they complete the full 4-cycle neoadjuvant regimen.
  • Patients receiving nivolumab achieved significantly higher pathological complete response rates compared to placebo, with benefits observed even in those who received fewer than 4 neoadjuvant treatment cycles due to toxicity or other factors.
  • The FDA has accepted a supplemental biologics license application for perioperative nivolumab in resectable stage IIA to IIIB NSCLC, based on the trial's primary endpoint showing improved event-free survival.
  • Safety data indicate that most patients who received adjuvant nivolumab completed the full one-year treatment course with a manageable adverse event profile.

A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer

NCT04025879Active, Not RecruitingPhase 3
Bristol-Myers Squibb
Posted 11/5/2019

Chugai's Vabysmo Receives Japanese Approval for Retinal Vein Occlusion Treatment

Drug Approval
  • Chugai Pharmaceutical has received approval from Japan's Ministry of Health for Vabysmo (faricimab) to treat macular edema associated with retinal vein occlusion, making it the first bispecific antibody approved for this condition in Japan.
  • The approval is based on positive results from the global Phase III BALATON and COMINO studies, which demonstrated Vabysmo's ability to rapidly improve vision and reduce retinal fluid in RVO patients.
  • Retinal vein occlusion affects an estimated 28 million adults globally and 1.66 million in Japan, representing the second most common cause of vision loss due to retinal vascular diseases.

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.

Bayer's High-Dose Eylea 8mg (Aflibercept) Accepted for Review by China's NMPA Following UK Approval

Drug Approval
• China's National Medical Products Administration (NMPA) has accepted Bayer's application for Eylea 8mg (aflibercept) to treat neovascular age-related macular degeneration for regulatory review.
• The UK's Medicines and Healthcare products Regulatory Agency (MHRA) recently approved Eylea 8mg for both wet AMD and diabetic macular edema, adding to existing approvals in the US, EU, and Japan.
• Phase III PULSAR trial results demonstrated that aflibercept 8mg maintained non-inferior visual acuity compared to the standard 2mg dose, while allowing most patients to extend treatment intervals to 12 or 16 weeks.

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.

Glofit and Obin in Follicular Lymphoma and Marginal Zone Lymphoma

NCT05783596Active, Not RecruitingPhase 2
Reid Merryman, MD
Posted 7/18/2023

CAR-T Followed by Bispecific Antibodies

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

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

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

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

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

Tazemetostat and Mosunetuzumab in Untreated Follicular Lymphoma

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

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

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

Innovent's Mazdutide Achieves Phase 3 Success in Chinese Obesity Trial, Paving Way for First GLP-1R/GCGR Dual Agonist Approval

Drug Approval
  • Innovent Biologics announced that mazdutide, a novel GLP-1R/GCGR dual agonist, successfully met all primary and key secondary endpoints in the GLORY-1 Phase 3 trial for weight management in Chinese adults with overweight or obesity.
  • The 48-week study of 610 participants demonstrated superior weight loss efficacy compared to placebo, with both 4 mg and 6 mg doses showing significant improvements in body weight reduction and cardiometabolic parameters.
  • Mazdutide represents the first GLP-1R/GCGR dual agonist to succeed in Phase 3 trials, with Innovent planning to submit a new drug application to China's NMPA in the near term.
  • The trial results address a critical unmet medical need in China, which has the world's highest number of obese individuals, with obesity-related deaths accounting for 11.1% of chronic disease mortality in 2019.

A Study of IBI362 in Participants With Obesity or Overweight

NCT05607680CompletedPhase 3
Innovent Biologics (Suzhou) Co. Ltd.
Posted 11/14/2022

Talquetamab Dose Reductions Maintain Efficacy While Reducing Toxicities in Relapsed/Refractory Multiple Myeloma

Drug Approval
  • Dose modifications of talquetamab effectively reduced GPRC5D-related adverse events while maintaining high response rates in patients with relapsed/refractory multiple myeloma.
  • Prospective data showed a 79.2% objective response rate with dose-reduced talquetamab, comparing favorably to the original registrational cohort.
  • Following dose reduction, new-onset oral toxicity dropped from 84.2% to 22.2%, and skin toxicity declined from 73.7% to 5.6%.
  • The findings support flexible dosing strategies to improve patient experience while preserving therapeutic efficacy in responding patients.

A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma

NCT04634552RecruitingPhase 2
Janssen Research & Development, LLC
Posted 2/1/2021

Dose Escalation Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma

NCT03399799Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 12/16/2017

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