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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.

NHS Becomes First Health System Globally to Approve 'Trojan Horse' Cancer Therapy for Multiple Myeloma

Drug ApprovalTargeted TherapyOncology
  • The NHS in England has become the first health system worldwide to approve belantamab mafodotin (Blenrep), a novel antibody-drug conjugate therapy for multiple myeloma patients.
  • Clinical trials demonstrated the treatment delayed disease progression by an average of three years compared to just over one year with standard daratumumab therapy.
  • Approximately 1,500 patients annually with relapsed or refractory multiple myeloma will be eligible for this targeted therapy through the NHS Cancer Drugs Fund.
  • The "Trojan horse" mechanism allows the drug to infiltrate cancer cells and release lethal molecules from within, representing a significant advancement in myeloma treatment.

Elanco's Zenrelia Receives Positive EU Regulatory Opinion for Canine Allergic Dermatitis Treatment

Drug ApprovalDrug Approval
  • Elanco Animal Health's Zenrelia (ilunocitinib) received a positive opinion from the European Medicines Agency's Committee for Veterinary Medicinal Products, paving the way for EU marketing authorization within 60 days.
  • The regulatory committee recommended approval based on demonstrated efficacy in treating pruritus associated with allergic dermatitis and clinical manifestations of atopic dermatitis in dogs.
  • Zenrelia represents Elanco's fastest globalized veterinary product with eight major regulatory approvals expected within 18 months, already available in Brazil, Canada, Japan, and the United States.
  • The company expects to launch the product in the EU market before the end of the third quarter, with additional approvals anticipated in Australia and the United Kingdom in 2025.

FDA Approves Roche-AbbVie's Venclexta Plus Gazyva as First-Line Chemotherapy-Free Treatment for CLL

Drug Approval
  • The FDA has approved Venclexta (venetoclax) in combination with Gazyva (obinutuzumab) for previously untreated chronic lymphocytic leukemia and small lymphocytic lymphoma patients.
  • The approval is based on phase 3 CLL14 trial results showing significant reduction in disease progression risk compared to standard Gazyva plus chemotherapy treatment.
  • This represents the first chemotherapy-free, fixed-duration treatment option for first-line CLL therapy, potentially expanding the patient population by approximately 20,000 in the US.
  • Venclexta generated $344 million in worldwide sales last year, with AbbVie projecting sales to reach $725 million this year following the expanded indication.

Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL

NCT03836261Active, Not RecruitingPhase 3
Acerta Pharma BV
Posted 2/25/2019

FDA Approves First Non-Surgical Treatment for Non-Muscle Invasive Bladder Cancer

Drug ApprovalOncology
  • The FDA approved UroGen Pharma's Zusduri as the first drug to treat non-muscle invasive bladder cancer that hasn't spread beyond the inner layers of the organ.
  • In a late-stage trial with 223 patients, 78% showed complete response with all signs of cancer disappearing after treatment.
  • The gel-based formulation offers a non-surgical alternative to traditional procedures, administered as a simple drug instillation in a doctor's office.
  • The approval addresses a significant unmet need for approximately 82,000 Americans affected by this type of bladder cancer annually, with 59,000 experiencing recurrence.

Amneal Secures FDA Approval for Generic Prednisolone Acetate Eye Drops, Targeting $201 Million Market

Drug Approval
  • Amneal Pharmaceuticals received FDA approval for prednisolone acetate ophthalmic suspension 1%, a generic version of Allergan's Pred Forte for treating steroid-responsive ocular inflammation.
  • The complex generic product will launch in Q3 2025, entering a market with approximately $201 million in annual U.S. sales according to IQVIA data.
  • The approval represents a key milestone for Amneal's Affordable Medicines segment, demonstrating the company's R&D capabilities in developing complex ophthalmic formulations.
  • Common adverse reactions include elevated intraocular pressure with potential glaucoma development, optic nerve damage, cataract formation, and delayed wound healing.

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