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Lupin Receives FDA Approval for Generic Bromfenac Ophthalmic Solution for Post-Cataract Surgery Treatment

Drug Approval
  • Lupin Limited received FDA approval for its abbreviated new drug application (ANDA) for bromfenac ophthalmic solution 0.09%, a generic equivalent of Bausch + Lomb's Bromday ophthalmic solution.
  • The topical NSAID is indicated for treating postoperative inflammation and reducing ocular pain following cataract surgery, with a dosing regimen of one drop daily starting one day before surgery through 14 days post-surgery.
  • The generic product will be manufactured at Lupin's Pithampur facility in India and targets an estimated annual US market worth $11 million according to IQVIA data.
  • The approval enables Lupin to market a lower-cost alternative to the brand-name drug without requiring costly clinical trials, as the generic demonstrated bioequivalence to the original formulation.

European Regulators Recommend Cabometyx for Radioactive Iodine-Refractory Thyroid Cancer Based on 78% Reduction in Disease Progression

Drug Approval
  • The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Cabometyx (cabozantinib) for treating radioactive iodine-refractory differentiated thyroid cancer patients who have progressed after prior systemic therapy.
  • The recommendation is based on the COSMIC-311 Phase III trial, which demonstrated a 78% reduction in risk of disease progression or death versus placebo (HR: 0.22; 96% CI: 0.13-0.36; p<0.0001) with a median progression-free survival of 11.0 versus 1.9 months.
  • This positive opinion addresses a critical unmet medical need, as there are currently no standard-of-care treatment options for patients with radioactive iodine-refractory differentiated thyroid cancer who progress after first-line therapy.
  • The CHMP recommendation follows the FDA's approval of Cabometyx in September 2021 for the same indication in adult and pediatric patients 12 years and older.

First Veteran Receives FDA-Approved Qalsody for SOD1-ALS at Houston VA Medical Center

NeurologyRare DiseaseDrug ApprovalFDA Approval
  • Roy Swearingen, a 65-year-old Marine Corps veteran from Texas, became the first veteran in the United States to receive Qalsody, an FDA-approved medication for SOD1-mutated ALS.
  • Qalsody represents the first approved treatment targeting a genetic cause of ALS, specifically for patients with mutations in the superoxide dismutase 1 (SOD1) gene, affecting 1-2% of ALS patients.
  • The Houston VA ALS Center's rapid implementation of this cutting-edge therapy demonstrates the VA's commitment to providing veterans with timely access to innovative treatments.
  • Veterans face higher ALS risk compared to the general population, making early detection and specialized care crucial for optimal quality of life management.

U.S. Tuberous Sclerosis Drug Market Projected to Reach $1.25 Billion by 2030, Growing at 23.1% CAGR

Drug ApprovalNeurologyRare Disease
  • The U.S. tuberous sclerosis drug market is expected to grow from $237.2 million in 2022 to $1.25 billion by 2030, driven by FDA approvals of new treatments and increasing disease prevalence.
  • FDA-approved treatments include Afinitor (everolimus) for patients aged 2 and above, approved in 2018, and Epidiolex (cannabidiol) for patients aged 1 and above, approved in 2020.
  • mTOR inhibitors are gaining significant traction in treatment protocols, showing effectiveness for internal tumors and skin lesions, with FDA approval for treating lung complications like Lymphangioleiomyomatosis (LAM) in 2015.

USDA Approves First Therapeutic Treatment for Canine Parvovirus Using Monoclonal Antibody Technology

Monoclonal AntibodyDrug Approval
  • The USDA has granted conditional license for Elanco's Canine Parvovirus Monoclonal Antibody, marking the first approved therapeutic solution to treat canine parvovirus.
  • In efficacy studies, all 28 treated puppies survived with significantly faster recovery times for vomiting, inappetence, and lethargy compared to traditional supportive care.
  • The single intravenous dose treatment could reduce hospitalization costs and make parvovirus treatment more accessible to pet owners who previously couldn't afford intensive care.
  • This breakthrough represents the first monoclonal antibody treatment for Elanco and addresses a critical unmet need in veterinary medicine for a disease with over 90% fatality rate if untreated.

Novel BCMA-Targeted Therapies and Emerging Agents Transform Treatment Landscape for Relapsed/Refractory Multiple Myeloma

CAR-TDrug Approval
  • BCMA-directed therapies including CAR T-cell products ide-cel and cilta-cel, along with bispecific T-cell engager teclistamab, have demonstrated unprecedented efficacy in heavily pretreated patients with relapsed/refractory multiple myeloma.
  • Emerging bispecific antibodies elranatamab and talquetamab show promising response rates of 61-74% in triple-class refractory patients, offering new treatment options for those who have exhausted conventional therapies.
  • Novel agents including mezigdomide (a CELMoD), purinostat mesylate (HDAC inhibitor), and bispecific CS1-BCMA CAR T cells are expanding therapeutic options with manageable safety profiles.
  • The treatment paradigm is shifting toward earlier use of BCMA-targeted therapies and novel combinations, as patients increasingly become refractory to multiple drug classes including immunomodulators, proteasome inhibitors, and anti-CD38 antibodies.

Isatuximab, Pomalidomide, Elotuzumab and Dexamethasone in Relapsed And/or Refractory Multiple Myeloma

NCT04835129RecruitingPhase 2
Medical College of Wisconsin
Posted 1/10/2022

Selinexor and Backbone Treatments of Multiple Myeloma Patients

NCT02343042Active, Not RecruitingPhase 1
Karyopharm Therapeutics Inc
Posted 10/1/2015

Trastuzumab Deruxtecan Gains Regulatory Approvals in China and Europe for HER2-Positive Cancers

Drug ApprovalMonoclonal Antibody
  • China's National Medical Products Administration approved trastuzumab deruxtecan for HER2-positive breast cancer patients who received prior anti-HER2 therapies, based on DESTINY-Breast03 trial showing 72% reduction in disease progression risk.
  • The European Commission approved trastuzumab deruxtecan as second-line treatment for HER2-positive advanced gastric cancer, marking the first antibody-drug conjugate approved in Europe for this indication.
  • DESTINY-Breast03 demonstrated superior efficacy with median progression-free survival not reached for trastuzumab deruxtecan versus 6.8 months for trastuzumab emtansine.
  • The approvals expand treatment options for patients with HER2-positive cancers who face poor outcomes after initial therapy progression.

Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]

NCT03734029Active, Not RecruitingPhase 3
Daiichi Sankyo
Posted 12/27/2018

FDA Approves Elacestrant as First Oral SERD for Advanced ER+/HER2- Breast Cancer

Drug Approval
  • The FDA has approved elacestrant (Orserdu), marking the first oral selective estrogen receptor degrader (SERD) to demonstrate improved efficacy over standard of care treatments in advanced breast cancer.
  • In the phase 3 EMERALD trial, elacestrant reduced the risk of progression or death by 30% in all patients and by 45% in patients with ESR1 mutations compared to standard endocrine therapy.
  • The approval provides a new oral treatment option for patients with estrogen receptor-positive/HER2-negative advanced or metastatic breast cancer following prior endocrine therapy including CDK4/6 inhibitors.
  • Elacestrant showed manageable safety profile with nausea being the most common adverse event, occurring in 35% of patients in the treatment arm.

A Study Evaluating the Efficacy and Safety of Giredestrant Compared With Physician's Choice of Endocrine Monotherapy in Participants With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (acelERA Breast Cancer)

NCT04576455Active, Not RecruitingPhase 2
Hoffmann-La Roche
Posted 11/27/2020

ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study

NCT05596409Active, Not RecruitingPhase 2
Stemline Therapeutics, Inc.
Posted 5/19/2023

Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer

NCT05563220RecruitingPhase 1
Stemline Therapeutics, Inc.
Posted 1/24/2023

Study of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to ER+/HER-2- Breast Cancer

NCT05386108RecruitingPhase 1
Stemline Therapeutics, Inc.
Posted 8/31/2022

Phase 3 Trial of Elacestrant vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer

NCT03778931CompletedPhase 3
Stemline Therapeutics, Inc.
Posted 5/10/2019

A Study to Investigate Efficacy and Safety With Oral AZD9833 Compared With Intramuscular Fulvestrant in Post-menopausal Women at Least 18 Years of Age With Advanced ER-positive HER2 Negative Breast Cancer

NCT04214288Active, Not RecruitingPhase 2
AstraZeneca
Posted 4/22/2020

A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer

NCT04975308Active, Not RecruitingPhase 3
Eli Lilly and Company
Posted 10/4/2021

Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer

NCT04059484TerminatedPhase 2
Sanofi
Posted 10/22/2019

Study of Efficacy of Ribociclib After Progression on CDK4/6 Inhibition in Patients With HR+ HER2- Advanced Breast Cancer

NCT02632045CompletedPhase 2
Melissa K Accordino
Posted 3/1/2016

FDA Authorizes Novavax's Protein-Based COVID-19 Vaccine for US Adults

Drug Approval
• The US Food and Drug Administration has authorized Novavax's protein-based COVID-19 vaccine for adults, making it the fourth COVID-19 shot available in the United States.
• Novavax's vaccine uses traditional protein-based technology that has been employed for decades against diseases like hepatitis B and influenza, potentially appealing to the 27 million unvaccinated American adults skeptical of mRNA platforms.
• The US government has secured 3.2 million Novavax doses to be released after quality testing, though European uptake has been limited with only about 242,000 doses administered since its December launch.

Eagle Pharmaceuticals Submits NDA for Landiolol, Ultra-Short-Acting Beta Blocker for Critical Care Tachycardia

Drug Approval
  • Eagle Pharmaceuticals announced that AOP Orphan Pharmaceuticals submitted a new drug application to the FDA for landiolol, seeking approval for short-term reduction of ventricular rate in patients with supraventricular tachycardia.
  • Landiolol is an ultra-short-acting, cardio-selective beta-1 adrenergic blocker with a β1:β2 ratio of 255:1, making it the most cardioselective beta blocker available.
  • The drug is already commercially available in Japan and several European markets, with multiple clinical studies demonstrating its safety and efficacy for rapid short-term control of tachyarrhythmias.
  • If approved, Eagle expects five years of new chemical entity exclusivity and anticipates approval by mid-year 2023 based on FDA feedback from a Type C meeting.

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