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Vorasidenib Demonstrates Sustained Long-Term Efficacy in IDH-Mutant Grade 2 Glioma

Targeted TherapyDrug Approval
  • Extended follow-up data from the phase 3 INDIGO trial confirms vorasidenib's durable treatment benefit, with median progression-free survival not estimable versus 11.4 months for placebo.
  • The targeted therapy significantly reduced tumor growth rate and seizure frequency compared to placebo, with only 32% of vorasidenib patients experiencing disease progression versus 64% on placebo.
  • Safety profile remained manageable with fewer than 5% of patients discontinuing treatment due to adverse events and no treatment-related deaths reported.
  • These results strengthen the clinical evidence supporting vorasidenib as the first FDA-approved targeted therapy for grade 2 IDH-mutant glioma following surgical resection.

Vorasidenib Maintenance for IDH Mutant Astrocytoma

NCT06809322Not Yet RecruitingPhase 3
European Organisation for Research and Treatment of Cancer - EORTC
Posted 12/5/2025

Study of Vorasidenib and Pembrolizumab Combination in Recurrent or Progressive IDH-1 Mutant Glioma

NCT05484622RecruitingPhase 1
Institut de Recherches Internationales Servier
Posted 1/20/2023

Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)

NCT04164901Active, Not RecruitingPhase 3
Institut de Recherches Internationales Servier
Posted 1/5/2020

Study of Orally Administered AG-881 in Patients With Advanced Solid Tumors, Including Gliomas, With an IDH1 and/or IDH2 Mutation

NCT02481154CompletedPhase 1
Institut de Recherches Internationales Servier
Posted 6/1/2015

Vorasidenib in Combination With Temozolomide (TMZ) in IDH-mutant Glioma

NCT06478212RecruitingPhase 1
Institut de Recherches Internationales Servier
Posted 1/22/2025

FDA Drug Center Chief George Tidmarsh Resigns Amid Ethics Probe and Industry Lawsuit

Drug Approval
  • Dr. George Tidmarsh, head of the FDA's drug center, abruptly resigned Sunday after federal officials began reviewing "serious concerns about his personal conduct."
  • Aurinia Pharmaceuticals filed a lawsuit alleging Tidmarsh used his FDA position to pursue a "longstanding personal vendetta" against the company's board chair Kevin Tang.
  • The company claims Tidmarsh's LinkedIn post criticizing their kidney drug caused a 20% stock drop, wiping out over $350 million in shareholder value.
  • Tidmarsh's departure adds to ongoing leadership turmoil at the FDA, which has lost over 1,000 drug center staffers in the past year.

NICE Reverses Course on Abiraterone, Recommends Generic Version for Metastatic Prostate Cancer

Drug Approval
  • NICE has published final draft guidance recommending generic abiraterone in combination with androgen deprivation therapy for adults with newly diagnosed high-risk hormone-sensitive metastatic prostate cancer.
  • The decision reverses NICE's 2021 guidance that rejected abiraterone due to cost concerns, with the availability of lower-cost generic versions prompting this re-evaluation.
  • Up to 4,000 patients could benefit from this expanded access, while the NHS could potentially save millions annually compared to using alternative treatments like enzalutamide and apalutamide.
  • The recommendation demonstrates NICE's new whole life-cycle approach to guidance development, allowing more responsive updates when circumstances change regarding evidence, pricing, or clinical practice.

Amneal Receives FDA Tentative Approval for Generic Asthma Inhaler, Targeting $329M Market

Drug Approval
  • Amneal Pharmaceuticals received FDA tentative approval for beclomethasone dipropionate HFA inhalation aerosol, a generic version of Teva's QVAR asthma treatment.
  • The corticosteroid inhaler is indicated for maintenance treatment of asthma in patients five years and older, representing Amneal's first metered-dose inhaler product.
  • The generic targets a significant market opportunity, with annual U.S. sales of approximately $329 million for the 12 months ended August 2025.
  • This milestone establishes a new growth vector for Amneal's Affordable Medicines segment and marks expansion into complex respiratory therapies.

FDA Proposes Streamlined Biosimilar Approval Process to Reduce Drug Costs by 50%

Drug Approval
  • The FDA announced new draft guidance to simplify biosimilar approval by reducing clinical testing requirements and shortening development timelines.
  • Biosimilars typically cost 50% less than brand-name biologics and drive down original drug prices by an additional 25% through market competition.
  • The streamlined process aims to accelerate access to affordable treatments for cancer, autoimmune diseases, and rare disorders affecting millions of Americans.
  • FDA Commissioner Marty Makary stated the final guidance will be released within three to six months as part of broader Trump administration drug pricing initiatives.

FDA Proposes Streamlined Approval Pathway to Accelerate Biosimilar Drug Development

Drug Approval
  • The U.S. FDA released draft guidance proposing to reduce human clinical study requirements for certain biosimilar drugs and treat them more like generic medications to accelerate market availability.
  • HHS Secretary Robert F. Kennedy Jr. stated that companies may not always need to conduct large, expensive human trials when advanced testing can prove biosimilars work as effectively and safely as original drugs.
  • The initiative aims to address multiple barriers facing biosimilars including physician hesitancy, reimbursement policies, and complex patent litigation that have limited uptake of these cost-saving alternatives.
  • FDA Commissioner Marty Makary emphasized the agency's commitment to promoting interchangeability, with final guidance expected within three to six months.

Alembic Pharmaceuticals Receives FDA Approval for Generic Ticagrelor 60mg Tablets for Acute Coronary Syndrome

Drug Approval
  • Alembic Pharmaceuticals Limited received final FDA approval for its generic ticagrelor tablets 60mg, therapeutically equivalent to AstraZeneca's Brilinta.
  • The medication is indicated to reduce cardiovascular death, myocardial infarction, and stroke risk in patients with acute coronary syndrome or history of MI.
  • The approved generic has an estimated market size of $236 million for the twelve months ending June 2025 according to IQVIA data.
  • This approval adds to Alembic's portfolio of 227 total ANDA approvals from the FDA, including a previously approved 90mg strength of ticagrelor.

UCB Presents New Clinical Data for Two Myasthenia Gravis Therapies at Major Medical Conferences

Monoclonal AntibodyDrug ApprovalRare Disease
  • UCB will present 18 abstracts at the 2025 AANEM Annual Meeting and MGFA Scientific Session, showcasing new data on rozanolixizumab (RYSTIGGO) and zilucoplan (ZILBRYSQ) for generalized myasthenia gravis treatment.
  • Key presentations include post hoc analyses on corticosteroid dose tapering with rozanolixizumab from the Phase 3 MycarinG study and quality of life improvements with zilucoplan from the RAISE-XT trial.
  • The data encompasses long-term safety profiles, treatment effectiveness, and real-world insights from patient management applications, reinforcing UCB's commitment to advancing gMG care.

Sunshine Biopharma Secures Health Canada Approval for Domperidone to Treat Cancer-Related Nausea

Drug Approval
  • Sunshine Biopharma's subsidiary Nora Pharma received Health Canada approval to commercialize domperidone, a prescription medication for chemotherapy-induced nausea and vomiting.
  • The approval provides access to a significant market opportunity, with North American domperidone sales reaching $533 million in 2025 and projected to grow to $781 million by 2033.
  • Domperidone works by blocking dopamine receptors in the gut and is particularly valuable for cancer patients who cannot tolerate other antiemetics due to side effects.
  • This regulatory milestone expands Sunshine Biopharma's generic drug portfolio, which currently includes 76 prescription medications available in Canada.

South Africa Approves Groundbreaking Twice-Yearly HIV Prevention Injection Lenacapavir

Drug Approval
  • South Africa becomes the first African nation to approve lenacapavir, a revolutionary HIV prevention injection that provides six months of protection per dose, marking a significant advancement in HIV prevention strategies.
  • The South African Health Products Regulatory Authority (SAHPRA) approved the drug in just eight months through collaboration with the European Medicines Agency, representing an unusually fast regulatory process.
  • A limited public sector rollout is planned for April 2026 across 360 high-performing clinics in 23 high-incidence districts, targeting high-risk populations including pregnant women, adolescent girls, and key populations.
  • Generic versions expected from 2027 at $40 per person per year will make the treatment more affordable than current daily prevention pills, potentially transforming HIV prevention accessibility in South Africa.

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