Zolbetuximab

Vyloy Leads Claudin 18.2 Targeted Therapy Revolution with 60+ Drug Candidates in Pipeline

10 hours ago

• Vyloy (zolbetuximab) has emerged as the first approved Claudin 18.2-targeted therapy for HER2-negative gastric and gastroesophageal junction adenocarcinoma, marking a significant milestone in precision oncology. • The global Claudin 18.2 therapy market is rapidly expanding with over 60 drug candidates in clinical trials, including monoclonal antibodies, bispecific antibodies, CAR-T cell therapies, and antibody-drug conjugates. • China has become a major innovation hub for Claudin 18.2-targeted therapies, with companies like Innovent, MabWorks, and Biotheus leading development efforts as research expands beyond gastric cancers to other solid tumors.

Astellas to Present New Long-Term Survival Data for Cancer Therapies at ASCO 2025

3 days ago

• Astellas will showcase 16 abstracts at the 2025 ASCO Annual Meeting, including two oral presentations highlighting long-term survival data for its oncology portfolio. • New post-hoc analyses will feature five-year overall survival data for XTANDI (enzalutamide) in metastatic hormone-sensitive prostate cancer and exploratory analyses for PADCEV (enfortumab vedotin) in urothelial cancer. • The presentations underscore Astellas' commitment to delivering meaningful clinical outcomes for patients with advanced prostate and bladder cancers through innovative treatment approaches.

CDMO Market Report: Key Regulatory Approvals and Clinical Advances in March-April 2025

a month ago

• Multiple CDMOs secured significant contract manufacturing opportunities as regulatory bodies approved new indications for established drugs, particularly in oncology and rare diseases. • AstraZeneca's portfolio saw substantial growth with expanded approvals for Imfinzi, Tagrisso, and Lynparza, strengthening partnerships with contract manufacturers including Lonza, Dottikon, and Samsung Biologics. • Contract manufacturers supporting treatments for autoimmune conditions showed strong performance, with Argenx's Vyvgart Hytrulo receiving expanded indications for myasthenia gravis and CIDP.

Global Pharma Launch Trends 2024: APAC Markets Gain Ground as Innovation Hubs

3 months ago

• Analysis of 33 innovative drugs launched in 2024 reveals shifting market dynamics, with South Korea and Japan emerging as early-launch destinations alongside traditional markets like the US. • Oncology dominated new drug launches with 47% market share, followed by neurological disorders, while orphan drugs represented 53% of new launches, suggesting potential peak in rare disease investment. • Healthcare reforms in South Korea and Japan, including improved pricing policies and reimbursement systems, have enhanced their attractiveness for pharmaceutical launches.

Vyloy (Zolbetuximab) Approved for Gastric and GEJ Cancer Treatment

5 months ago

Vyloy, a new cancer medication targeting Claudin 18.2 on cancer cells, has been FDA-approved for treating gastric and gastroesophageal junction (GEJ) cancer. It is used in combination with chemotherapy to slow tumor growth and improve survival rates.

FDA Grants Priority Review to Astellas' Zolbetuximab for Gastric and GEJ Adenocarcinoma

5 months ago

• The FDA has granted Priority Review to Astellas' Biologics License Application (BLA) for zolbetuximab, a Claudin 18.2-targeted monoclonal antibody. • Zolbetuximab is intended as a first-line treatment for locally advanced or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. • The BLA is supported by positive results from the Phase 3 SPOTLIGHT and GLOW trials, evaluating zolbetuximab in combination with chemotherapy regimens. • The FDA's target action date is set for January 12, 2024, potentially making zolbetuximab the first Claudin 18.2-targeted therapy available in the US.

China NMPA Approves Astellas' Zolbetuximab for Advanced Gastric and GEJ Adenocarcinoma

5 months ago

• China's NMPA has approved zolbetuximab (VYLOY™) for first-line treatment of HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. • Zolbetuximab is the first monoclonal antibody approved in China that targets the CLDN18.2 biomarker expressed in gastric tumor cells. • Approval was based on Phase 3 GLOW and SPOTLIGHT trials, showing statistically significant improvements in progression-free and overall survival. • Approximately 35% of Chinese patients with advanced gastric and GEJ cancers have tumors expressing the CLDN18.2 biomarker.

Elevation Oncology: Promising Cancer Therapies Earn Analyst Praise

5 months ago

William Blair analyst Andy Hsieh praises Elevation Oncology for its promising cancer therapies, particularly its antibody-drug conjugate expertise targeting Claudin 18.2 and HER3, highlighting a favorable risk-to-reward ratio and significant market potential.

Biomarker-Guided Therapies Transform Treatment Landscape Across Multiple Cancers

5 months ago

• Recent advances in targeted therapies including KRAS, BRAF, and CLDN18.2 inhibitors are revolutionizing treatment approaches for pancreatic, colorectal, lung and gastric cancers through molecular profiling-guided precision medicine. • Zolbetuximab plus chemotherapy demonstrated significant survival benefits in CLDN18.2-positive gastric cancer, while KRAS inhibitors showed promising response rates of 20-45% in pancreatic cancer patients with specific mutations. • Multiple biomarker-targeted approaches including HER2, PD-L1, and FGFR2 are expanding treatment options across gastrointestinal cancers, though optimal sequencing strategies are still being determined.

FDA Wraps Up 2024 with Key Approvals for Drugs Targeting Various Conditions

6 months ago

• The FDA approved Vertex's Alyftrek for cystic fibrosis, offering improved dosing and potential market exclusivity. • Novo Nordisk's Alhemo was approved for hemophilia A and B, providing a new option for patients with inhibitors. • Bristol Myers Squibb's Opdivo Qvantig gained approval as a subcutaneous formulation, offering faster administration for various solid tumors. • Eli Lilly's Zepbound secured approval for obstructive sleep apnea in obese adults, marking the first prescription medicine for this condition.

FDA Approves Tevimbra Plus Chemotherapy for First-Line Treatment of Gastric and GEJ Adenocarcinoma

6 months ago

• The FDA has approved Tevimbra (tislelizumab-jsgr) in combination with chemotherapy for first-line treatment of HER2-negative gastric or gastroesophageal junction adenocarcinoma with PD-L1 expression. • The approval was based on the RATIONALE-305 trial, which showed a median overall survival of 15.0 months with Tevimbra plus chemotherapy compared to 12.9 months with chemotherapy alone. • Common side effects of Tevimbra in combination with chemotherapy include decreased blood cell counts, fatigue, and gastrointestinal issues, but the combination offers a manageable safety profile. • This approval marks the second for Tevimbra in 2024, highlighting its potential to address critical needs in oncology and providing a valuable new treatment option.

FDA Approves Zolbetuximab for CLDN18.2-Positive Gastric and GEJ Adenocarcinoma

6 months ago

• The FDA approved zolbetuximab in combination with chemotherapy for HER2-negative, CLDN18.2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma on October 18, 2024. • Approval was based on the SPOTLIGHT and GLOW phase 3 trials, which demonstrated improved progression-free and overall survival with zolbetuximab plus chemotherapy. • Zolbetuximab targets CLDN18.2, a protein overexpressed in 50-80% of gastric cancers, offering a new targeted therapy option for previously non-targetable disease. • Routine CLDN18.2 testing is now crucial to identify patients who can benefit from zolbetuximab, establishing it as a standard of care in the first-line setting.

Claudin 18.2-Targeted Therapies Show Promise in Gastric and Other Cancers

6 months ago

• Claudin 18.2 (CLDN18.2) is a highly selective biomarker abnormally expressed in gastric, gastroesophageal junction, ovarian cancers, and some solid tumors, making it a target for cancer therapies. • Vyloy (zolbetuximab) gained approval in major markets like the US, EU, and Japan, as a first-line treatment with chemotherapy for HER2-negative G/GEJ adenocarcinoma expressing Claudin18.2. • Over 60 Claudin 18.2-targeting drugs are in clinical trials, including monoclonal antibodies, bispecific antibodies, CAR-T cell therapies, and antibody-drug conjugates, showing promise in various cancers. • Companion diagnostics, such as Roche's Ventana CLDN18 (43-14A) RxDx Assay, are crucial for identifying patients most likely to benefit from Claudin18.2-targeted therapies, improving treatment outcomes.

Vyloy Approval in Korea Faces Reimbursement Hurdles Despite Clinical Promise

6 months ago

• Vyloy (zolbetuximab), the first Claudin 18.2-targeted gastric cancer drug, has been approved in Korea for advanced gastric cancer treatment. • Concerns arise that Korea's reimbursement system may impede patient access to Vyloy, despite its potential to significantly improve survival rates. • The Health Insurance Review and Assessment Service (HIRA) is reviewing the companion diagnostic device (CDx) for Claudin 18.2, potentially delaying Vyloy's launch. • Experts advocate for policy improvements to support the synchronized introduction of targeted drugs and their companion diagnostics in Korea.

FDA Approves Zolbetuximab for CLDN18.2-Positive Gastric and GEJ Adenocarcinoma

6 months ago

• The FDA approved zolbetuximab in combination with chemotherapy for first-line treatment of locally advanced, unresectable, or metastatic HER2-negative gastric or GEJ adenocarcinoma. • Approval was based on the SPOTLIGHT and GLOW trials, which demonstrated improved survival with the addition of zolbetuximab to standard chemotherapy regimens. • Zolbetuximab targets CLDN 18.2, a protein involved in cell adhesion, offering a novel approach for managing this challenging cancer type. • Biomarker testing for CLDN 18.2 is now crucial for guiding treatment strategies and improving outcomes in gastric and GEJ adenocarcinoma.

FDA Approves Zolbetuximab for CLDN18.2-Positive Gastric and GEJ Adenocarcinoma

6 months ago

• The FDA approved zolbetuximab (Vylov) in combination with chemotherapy for first-line treatment of CLDN18.2-positive, HER2-negative gastric or GEJ adenocarcinoma. • The approval was based on the SPOTLIGHT and GLOW trials, which demonstrated improved progression-free survival with zolbetuximab plus chemotherapy. • Zolbetuximab targets Claudin 18.2 (CLDN18.2), a protein expressed in gastric cancer, offering a new targeted therapy option. • Clinicians should test for CLDN18.2 expression to identify patients who may benefit from zolbetuximab treatment.

FDA's Manufacturing Concerns Delay Access to Promising Drugs

6 months ago

• The FDA has recently rejected drugs for acromegaly and gastric cancer due to manufacturing facility deficiencies, despite evidence of their safety and efficacy. • This risk-averse approach delays patient access to potentially life-improving medications, such as CAM2029 for acromegaly and zolbetuximab for gastric cancer. • Experts suggest the FDA should prioritize recalls for faulty batches over rejecting entire medications, especially when drugs meet safety and efficacy standards. • Calls are growing for legislative reform to prevent manufacturing issues from being the sole basis for drug rejections, advocating for a more flexible approach.

Zolbetuximab Plus Chemotherapy Improves Survival in CLDN18.2-Positive Gastric and GEJ Adenocarcinoma

6 months ago

• Zolbetuximab combined with chemotherapy significantly improves progression-free survival (PFS) and overall survival (OS) in patients with HER2-negative, CLDN18.2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. • Pooled analysis of the SPOTLIGHT and GLOW trials demonstrated a median PFS of 9.2 months with zolbetuximab plus chemotherapy compared to 8.2 months with placebo plus chemotherapy. • The combination therapy also showed a median OS of 16.4 months versus 13.7 months in the placebo arm, with manageable gastrointestinal toxicities. • Zolbetuximab has received approval in Japan and Europe for CLDN18.2-positive gastric cancer and is awaiting approval in other regions.

Cobenfy: A Novel Schizophrenia Treatment Approved by FDA

6 months ago

• The FDA approved Cobenfy (xanomeline and trospium chloride) as a first-in-class treatment for schizophrenia, offering a new mechanism of action. • Cobenfy targets cholinergic receptors, unlike traditional dopamine receptor-targeting drugs, potentially reducing adverse side effects. • Clinical trials demonstrated significant improvements in schizophrenia symptoms with Cobenfy, including positive, negative, and cognitive aspects. • While promising, further research is needed to assess long-term tolerability and comparative effectiveness, with cost being a consideration.

FDA Weighs Removal of Oral Phenylephrine; Approves Drugs for CML, Gastric Cancer, and UTIs

6 months ago

• The FDA is considering removing oral phenylephrine from its OTC Monograph due to a lack of efficacy as a nasal decongestant, potentially impacting numerous cold and allergy products. • Novartis' Scemblix expands its FDA-approved uses to include the treatment of newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ PML). • Astellas Pharma's Vyloy (zolbetuximab) receives FDA approval as the first treatment targeting the CLDN18.2 protein for gastric or gastroesophageal junction adenocarcinoma. • Iterum Therapeutics' Orlynvah (sulopenem) gains FDA approval for treating uncomplicated urinary tract infections in women with limited oral antibacterial treatment options.

Drug Development Updates