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FDA Issues Second Complete Response Letter for Odronextamab in Relapsed/Refractory Follicular Lymphoma

Drug Approval
  • The FDA has issued a second complete response letter (CRL) for odronextamab's biologics license application, this time related to observations from an FDA site inspection at Catalent Indiana, LLC manufacturing facility.
  • Updated ELM-2 trial data with 28.3 months median follow-up demonstrate sustained efficacy with 80.5% overall response rate and 74.2% complete response rate in heavily pretreated follicular lymphoma patients.
  • The bispecific antibody received European Union approval in August 2024 for relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma after at least 2 prior therapies.
  • Safety profile remains consistent with previous reports, dominated by manageable cytokine release syndrome and infection-related adverse events requiring careful patient monitoring and prophylaxis.

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

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

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

Supernus Pharmaceuticals Acquires Sage Therapeutics for $795 Million, Strengthening Neuropsychiatry Portfolio

Drug Approval
  • Supernus Pharmaceuticals announced a definitive agreement to acquire Sage Therapeutics for $8.50 per share upfront plus contingent payments up to $3.50 per share, totaling up to $795 million.
  • The acquisition adds ZURZUVAE (zuranolone), the first and only FDA-approved oral treatment for postpartum depression, to Supernus' neuropsychiatry portfolio.
  • The deal is expected to be significantly accretive in 2026 with potential cost synergies of up to $200 million annually and strengthen Supernus' CNS discovery platforms.
  • ZURZUVAE generated $36.1 million in collaboration revenue for 2024, with Supernus receiving 50% of net revenue recorded by partner Biogen in the U.S.

Supernus Pharmaceuticals Acquires Sage Therapeutics for Up to $795 Million, Securing Postpartum Depression Drug Zurzuvae

Drug Approval
  • Supernus Pharmaceuticals agreed to acquire Sage Therapeutics for up to $795 million, offering $8.50 per share in cash plus contingent value rights worth $3.50 per share based on sales milestones.
  • The deal significantly exceeds Biogen's rejected $469 million unsolicited offer from January 2025, providing Sage shareholders with a 36% premium over previous trading levels.
  • Supernus gains exclusive U.S. rights to Zurzuvae, the only FDA-approved oral treatment for postpartum depression, which generated $36.1 million in 2024 sales and $13.8 million in Q1 2025.
  • The acquisition allows Supernus to diversify its CNS portfolio beyond its existing Parkinson's disease and ADHD treatments, while positioning the company for significant growth if Zurzuvae reaches projected sales milestones.

Biologic Therapies Transform Respiratory Care as Clinicians Embrace Earlier, Precision-Based Treatment Strategies

Precision MedicineDrug Approval
  • Biologic therapies including dupilumab, benralizumab, and tezepelumab have revolutionized asthma management by enabling biomarker-driven treatment strategies beyond traditional allergen or eosinophil-based models.
  • Dupilumab's 2024 FDA approval for eosinophilic COPD represents the first biologic therapy for this condition, marking a significant milestone in a field where treatment had previously stagnated.
  • Clinicians are increasingly adopting earlier biologic intervention strategies to minimize steroid exposure and prevent long-term adverse outcomes, with pulmonologists now managing biologics more independently.
  • The recognition of asthma and COPD as heterogeneous diseases with overlapping inflammatory pathways is driving a shift toward personalized medicine approaches guided by biomarkers like eosinophils and FeNO.

FDA Delays KalVista's Sebetralstat Approval Decision Due to Resource Constraints

Drug Approval
  • The FDA has extended its review of KalVista's sebetralstat for hereditary angioedema by four weeks past the June 17 deadline due to heavy workload and limited resources.
  • Sebetralstat would become the first on-demand oral treatment for hereditary angioedema if approved, offering a convenient alternative to injectable therapies.
  • The delay represents the first instance directly attributed to FDA resource constraints following agency restructuring under the Trump administration.
  • KalVista maintains confidence in near-term approval as the FDA has not requested additional data or raised safety concerns.

FDA Delays Sebetralstat Approval Decision for Hereditary Angioedema Treatment Due to Resource Constraints

Drug ApprovalRare Disease
  • The FDA will not meet the June 17, 2025 PDUFA goal date for KalVista's sebetralstat NDA due to heavy workload and limited resources, with a decision expected within four weeks.
  • Sebetralstat represents a potential breakthrough as the first oral on-demand treatment for hereditary angioedema attacks in patients aged 12 and older.
  • The FDA has not requested additional data or raised safety concerns, with only labeling finalization remaining under review according to KalVista.
  • The delay affects patients with hereditary angioedema who currently rely on intravenous or subcutaneous treatments for managing painful and potentially life-threatening attacks.

Ponatinib Shows Superior Survival Outcomes in Ph+ ALL Patients with Persistent MRD After Induction

Drug Approval
  • Post hoc analysis of the PhALLCON trial demonstrates that ponatinib achieved higher rates of deep molecular responses compared to imatinib in newly diagnosed Ph+ ALL patients who remained MRD-positive after induction therapy.
  • Patients with persistent MRD who continued ponatinib beyond cycle 3 showed significantly improved event-free survival with a median not reached versus 24.8 months for imatinib (HR 0.198, P = 0.0004).
  • The analysis supports continuing ponatinib treatment in Ph+ ALL patients who fail to achieve MRD negativity after initial induction, though researchers caution about the small patient numbers and potential selection bias.

A Study of Ponatinib Versus Imatinib in Adults With Acute Lymphoblastic Leukemia

NCT03589326Active, Not RecruitingPhase 3
Takeda
Posted 10/4/2018

EMA Recommends First EU Vaccine Against Swine Dysentery, Targeting Disease with 30-50% Mortality Rate

Drug Approval
  • The European Medicines Agency has issued a positive opinion for Biobhyo, the first vaccine authorized in the EU to protect pigs against swine dysentery disease.
  • Swine dysentery affects up to 90% of pigs in infected herds with a mortality rate of 30-50%, caused by the bacterium Brachyspira hyodysenteriae.
  • Clinical studies demonstrated vaccine efficacy when administered at five and eight weeks of age, showing reduced incidence of dysenteric diarrhea in commercial farm settings.
  • The Committee for Medicinal Products for Veterinary Use opinion will now proceed to the European Commission for final EU-wide marketing authorization.

Citius Pharmaceuticals Closes $15.8M Direct Offering to Fund LYMPHIR Commercial Launch

Drug ApprovalOncology
  • Citius Pharmaceuticals completed a $15.8 million registered direct offering with $6 million raised upfront and potential additional $9.8 million from warrant exercises.
  • The company plans to use proceeds to support the commercial launch of LYMPHIR, an FDA-approved targeted immunotherapy for cutaneous T-cell lymphoma.
  • The offering included 4.92 million shares at $1.22 per share with accompanying warrants exercisable at $1.00 per share over 24 months.
  • Citius maintains a late-stage pipeline including Mino-Lok for catheter-related infections and CITI-002 for hemorrhoid treatment, both having completed pivotal trials.

FDA Approves First-in-Human Trial for Novel CAR-T Therapy Targeting Neuroblastoma

CAR-TDrug Approval
  • The FDA has approved Myrio Therapeutics' IND application for PHOX2B PC-CAR T, marking the first human trial for a therapy targeting the PHOX2B protein in neuroblastoma cells.
  • The novel CAR-T therapy breaks HLA restriction by recognizing peptides across multiple HLA allotypes, potentially expanding treatment to a broader patient population.
  • Neuroblastoma affects approximately 800 children annually in the US and accounts for 15% of pediatric cancer deaths, with current high-risk treatments showing low response rates.
  • The Phase 1 trial will be led by Prof. John Maris at a leading Philadelphia children's hospital, with first patient enrollment anticipated for mid-2025.

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