Healthark Insights’ Post

Zolbetuximab, an investigational first-in-class monoclonal antibody treatment for patients with CLDN18.2-positive is in review under the FDA’s Real-Time Oncology Review (RTOR) program. If approved by the FDA, zolbetuximab would be the first therapy for these patients in the United States. Download the report to explore its competitive landscape, regulatory and safety concerns, here: https://lnkd.in/eKrkmVVU #Oncology #CancerResearch #Regulatory #FDA

FDA approved #osimertinib (Tagrisso, AstraZeneca Pharmaceuticals) for adult patients with locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. https://lnkd.in/gQSHea7U

Emerging Biopharma has become more increasingly invaluable to the development of cancer therapies over the last decade, up from 33% to 60% of trial starts over the span. Large pharma has conversely fell from 59% to just 28% over the decade. Interestingly, while large pharma oncology trials fell by 20% over the last 2 years, emerging biopharma trials remained stable - showing their resilience through economic turmoil. Read more about the state of oncology trials in IQVIA "Institute's Global Oncology Trends 2024" report: https://lnkd.in/eJsmZPSf #clinicaltrials #oncology

#China’s #CanSino Biologics' PD-1/VEGF New Drug Eboxizumab Sparks Revolution in Lung Cancer. It is currently approved in China for use in combination with pemetrexed and carboplatin for the treatment of EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC patients. https://lnkd.in/g_JHQ8un

🚀 Exciting Developments in Antibody Drug Conjugates! 🔬 🔔 Follow our page for interesting ADC updates! 🌟 Explore the latest edition of ADC Digest for this week of November 2024, featuring groundbreaking advancements in the field of Antibody Drug Conjugates. 💊VelaVigo Announces Exclusive Option Agreement with Avenzo to License a Potential First-in-Class Nectin4/TROP2 Bispecific Antibody-Drug Conjugate 💊LigaChem Biosciences receives near-term milestone payment for ‘LCB97’ from Japan’s Ono Pharmaceutical 💊Daiichi Sankyo and AstraZeneca’s Enhertu snubbed by UK’s NICE for third time 💊 FDA Fast Tracks ALE.P02 for CLDN1-Poisitive Solid Cancers 💊Pyxis Oncology Announces Favorable Preliminary PYX-201 Clinical Phase 1 Part 1 Data 💊AbbVie’s ELAHERE Receives EU Approval for Treating Platinum-Resistant Ovarian Cancer #ADC #MedicalInnovations #Innovation #ADCnews #CIScientists #Antibodydrugconjugate #cancer #competitiveintelligence

🧬 Monte Rosa Therapeutics makes strides in MYC-driven tumor research, advancing oncology innovation. Know complete story: https://lnkd.in/dbdrGHNQ ✅ FDA supports the continued progress of Theriva Biologics, Inc.'s VCN-01 trial, promising hope in targeted cancer therapies. Know complete story: https://lnkd.in/dUqpviHn 💉 Techne Injection set to launch in 2025, revolutionizing delivery systems in healthcare solutions. Know complete story: https://lnkd.in/dfJFJRdK 🌟 Imfinzi by AstraZeneca earns approval for LS-SCLC, expanding treatment options for small-cell lung cancer patients. Know complete story: https://lnkd.in/dPM9MR6E #PharmaNews #OncologyResearch #ClinicalTrials #HealthcareInnovation #FDAApproval #PharmaceuticalIndustry

Zai Lab's partners Pfizer and Genmab jointly announced that the US FDA has approved their supplementary Biologics License Application (sBLA) for TIVDAK(®). This sets the stage for its use in the treatment of patients who are suffering from recurrent or metastatic cervical cancer, whose condition has progressed during or after chemotherapy. There's a considerable unmet need for cervical cancer treatment. The disease - recurrent and/or metastatic cervical cancer - is extremely destructive and often incurable; statistics show that up to 15% of adult cervical cancer patients experience metastasis at diagnosis, and for those diagnosed early and treated, as many as 61%(v) suffer recurrences. #QMportfolio #QMhealthcare #ZaiLab #Pfizer #Genmab #FDA #TIVDAKApproval #CervicalCancerTreatment

Zolbetuximab, an investigational first-in-class monoclonal antibody treatment for patients with CLDN18.2-positive, HER2-negative, metastatic gastric (mG) or gastroesophageal junction (GEJ) adenocarcinoma is in review under the FDA’s Real-Time Oncology Review (RTOR) program. If approved by the FDA, zolbetuximab would be the first therapy for these patients in the United States. Download the report to explore its competitive landscape, regulatory and safety concerns, here: https://lnkd.in/eKrkmVVU #Oncology #CancerResearch #Regulatory #FDA

📣 More news releases in advance of the forthcoming #ASCO meeting in Chicago!! Results from Merck's TROP2-targeting ADC sacituzumab tirumotecan PIII OptiTROP-Breast01 trial were released ahead of #2024ASCO: ⤵ Showing "reduced the risk of disease progression or death by 69% versus chemotherapy in patients with unresectable locally advanced, recurrent or metastatic triple-negative breast cancer (TNBC) who have failed at least two prior therapies." Merck has also moved this asset into NSCLC. 🌎 Other global manufacturers with treatments in this TROP2 ADC space (BC and/or LC) include Gilead Sciences and AstraZeneca/Daiichi Sankyo US #Merck #Oncology #ADC #BreastCancer #TNBC #ASCO #AstraZeneca #AZ #Gilead #DaiichiSankyo #MedicalAffairs #Pharma #Healthcare

Mabwell (688062.SH), an innovative-driven biopharmaceutical company with entire industry chain, presented the clinical study data of the 9MW2821 for patients with cervical cancer as focused plenary oral presentation at the Society of Gynecologic Oncology (SGO) annual meeting on March 16, 2024. The data showed good efficacy and safety of 9MW2821 in patients with cervical cancer, which is expected to bring new breakthroughs for the treatment of recurrent or metastatic cervical cancer, meeting a large number of unmet clinical needs. 9MW2821 is the first drug to report clinical data for the indication of cervical cancer among the drugs with the same target in the world. Read more at: https://lnkd.in/eR4PTfBs #ADC #SGO