๐๐๐ฒ๐๐ซ ๐๐ง๐ง๐จ๐ฎ๐ง๐๐๐ฌ ๐๐จ๐ฌ๐ข๐ญ๐ข๐ฏ๐ ๐๐๐ฌ๐ฎ๐ฅ๐ญ๐ฌ ๐๐จ๐ซ ๐๐๐๐๐๐ยฎ ๐ข๐ง ๐๐ก๐๐ฌ๐ ๐๐๐ ๐๐๐๐๐๐๐ ๐๐ซ๐ข๐๐ฅ ๐๐จ๐ซ ๐๐๐ญ๐๐ฌ๐ญ๐๐ญ๐ข๐ ๐๐จ๐ซ๐ฆ๐จ๐ง๐-๐๐๐ง๐ฌ๐ข๐ญ๐ข๐ฏ๐ ๐๐ซ๐จ๐ฌ๐ญ๐๐ญ๐ ๐๐๐ง๐๐๐ซ Bayer Bayer reports that the Phase III ARANOTE trial of NUBEQAยฎ (darolutamide) plus androgen deprivation therapy (ADT) met its primary endpoint of radiological progression-free survival (rPFS) in metastatic hormone-sensitive prostate cancer (mHSPC). NUBEQA plus ADT significantly increased rPFS compared to placebo plus ADT, with no new safety signals observed. Christian Rommel, Ph.D. Christian Rommel, Head of Research and Development at Bayerโs Pharmaceuticals Division, stated, "Today's results build on the established efficacy and tolerability profile of NUBEQA. We look forward to sharing detailed results at an upcoming scientific congress and discussing regulatory approval with the FDA." The ARANOTE trial (NCT04736199) involved 669 patients and assessed the efficacy and safety of NUBEQA plus ADT in mHSPC patients. NUBEQA is already indicated in the U.S. for mHSPC in combination with docetaxel and for non-metastatic castration-resistant prostate cancer (nmCRPC). #Bayer #NUBEQA #ProstateCancer #ClinicalTrials #Oncology #PharmaNews #FDA #MedicalResearch
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Market Research Analyst | Healthcare Expert | Delivering Data-Driven Insights to Drive Business Success
๐ ๐ฌ๐๐๐๐๐๐๐ ๐ต๐๐๐ ๐๐ ๐ถ๐๐๐๐๐๐๐! ๐ Merck (MSD) has achieved FDA approval for ๐๐๐ฅ๐ข๐ซ๐๐ (๐๐๐ฅ๐ณ๐ฎ๐ญ๐ข๐๐๐ง), a breakthrough in treating ๐๐๐ฏ๐๐ง๐๐๐ ๐ซ๐๐ง๐๐ฅ ๐๐๐ฅ๐ฅ ๐๐๐ซ๐๐ข๐ง๐จ๐ฆ๐ (๐๐๐). This oral drug offers hope to patients unresponsive to PD-1/PD-L1 inhibitors and VEGF-TKI, demonstrating superior results in the LITESPARK-005 trial. ๐ฌ Welireg, acquired through the Peloton Therapeutics purchase, has shown impressive progression-free survival (PFS) at 12 and 18 months, surpassing Novartis' Afinitor. With an objective response rate (ORR) difference of 22%, Welireg stands out as a game-changer in RCC treatment. ๐ While interim results raised questions about overall survival (OS) at ESMO Congress, a final analysis is underway. Nonetheless, this HIF-2ฮฑ inhibitor marks a significant stride in targeting tumor development in kidney cells. ๐ Renal cell carcinoma affects 81,800 adults in the US annually. Welireg, despite its potential risks, introduces a vital treatment avenue, reducing the risk of disease progression or death compared to everolimus. ๐ฉโ๏ธ Dr. Toni Choueiri, LITESPARK-005 study chair, emphasizes the significance: "Belzutifan introduces a meaningful new treatment option for certain patients, addressing the gap in options for those progressing post PD-1/PD-L1 and TKI therapy." --------------------------------------------------------------------------------- ๐คWhat are your views on this FDA Approved ? --------------------------------------------------------------------------------- #fdaapproval #oncology #oncologytrials #carcinoma #marketresearcher #competitiveintelligence #clinicaltrial
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In the latest FDA Roundup,ย Dr. Richard Pazdur, director of FDAโs Oncology Center of Excellence (OCE), expresses his excitement forย the approval ofย LOQTORZIโขย (toripalimab-tpzi):ย โTodayโs approval of Loqtorzi is the first approval in the United States of a drug to treat nasopharyngeal carcinoma. When combined with chemotherapy this drug has demonstrated an improvement in overall survival as well as delaying the progression of disease in patients with metastatic or recurrent, locally advanced disease who had not received prior chemotherapy.โ An anti-PD-1 monoclonal antibody developed by Shanghai Junshi Biosciences Co Ltd and TopAlliance Biosciences Inc,ย LOQTORZIโข has been approved by the FDA for treating all lines of nasopharyngeal carcinoma (NPC). For NPC patients in the US, LOQTORZIโข offers renewed hope as it addresses a previously unmet medical need in the absence of NPC-specific treatments. FDA Roundup:ย https://lnkd.in/eU-bkith #FDAapproval #FDA #monoclonalantibody #pd1 #nasopharyngealcarcinoma #npc #medicalinnovation #loqtorzi #toripalimab #coherus #junshi #topalliance
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Our global partner Compass Therapeutics published a trial in progress paper on ABL001 (CTX-009) in the international journal โFuture Oncologyโ. This paper contains information on the research methodology, including study goals, clinical design and primary endpoints of COMPANION-002, a Phase 2/3 Randomized, Controlled Study of CTX-009 in Combination With Paclitaxel Versus Paclitaxel Alone in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers Who Have Received One Prior Systemic Chemotherapy Regimen. If you want to get more information about COMPANION-002, please see this paper: https://lnkd.in/exMdsUpQ
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#PaperSpotlight: On February 7, 2024, researcher Richard E. Kast from IIAIGC Study Center published a new research perspective in Oncoscience (Volume 11), entitled, โIPIAD- an augmentation regimen added to standard treatment of pancreatic ductal adenocarcinoma using already-marketed repurposed drugs irbesartan, pyrimethamine, itraconazole, azithromycin, and dapsone.โ โThis paper presents the rationale for adding five already approved and marketed generic drugs from general medical practice to the current standard current first line chemotherapy for pancreatic ductal adenocarcinoma (PDAC).โ #PressRelease: https://lnkd.in/gbuqptYJ #cancerresearch #pancreaticcancer #PDAC #oncology #openaccess #openscience #peerreviewed #meded #publishing #publication
Oncoscience | IPIAD: An Augmentation to Standard Treatment of PDAC Using Five Repurposed Drugs
oncoscience.us
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Back to 1992, when being approved as the first immunotherapy and used for treatment of metastatic renal cancer, IL-2 hasย long been seen as a shining beacon forย drugย developers.ย However, various failure in the past yearsย haveย led many toย questionย whether it is merely anย elusiveย andย unattainable unicorn. But failure sometimes could alsoย present opportunity. Inย drug development, we never lack courageous and tirelesslyย venturing warriors. Hanmi Pharmaceuticals, bringing their lead molecule, HM16390, is definitely one of them. As their novel IL-2 analog liked with human IgG4,ย Hanmi Pharmaceuticals has two posters introducing it in the Late-Breaking Research Poster session at the upcoming AACR 2024 conference (April 5-10) in San Diego.ย Based on the theirย public preclinical result, HM16390, by tuning its affinity toย IL-2Rฮฑย andย IL-2Rฮฒย respectively, shows effective anti-tumor efficacy while possessing good safety profile. Checkย link for moreย detail:ย https://www.aacr.org https://lnkd.in/g9wfHzGj Additionally, the 2024 Annual Conference of our society, featuring numerous novel modalities of biologics, will convene in Cambridge, MA, USA on Saturday, May 11, 2024. Registration for the conference is now open via the following link. https://lnkd.in/ecmFPA4v #antibodydiscoveryย #immunotherapy #oncologyย #annualmeetingย #annualconferenceย #aacr #cancer
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In the latest FDA Roundup,ย Dr. Richard Pazdur, director of FDAโs Oncology Center of Excellence (OCE), expresses his excitement forย the approval ofย LOQTORZIโขย (toripalimab-tpzi):ย โTodayโs approval of Loqtorzi is the first approval in the United States of a drug to treat nasopharyngeal carcinoma. When combined with chemotherapy this drug has demonstrated an improvement in overall survival as well as delaying the progression of disease in patients with metastatic or recurrent, locally advanced disease who had not received prior chemotherapy.โ An anti-PD-1 monoclonal antibody developed by Shanghai Junshi Biosciences Co Ltd and TopAlliance Biosciences Inc,ย LOQTORZIโข has been approved by the FDA for treating all lines of nasopharyngeal carcinoma (NPC). For NPC patients in the US, LOQTORZIโข offers renewed hope as it addresses a previously unmet medical need in the absence of NPC-specific treatments. FDA Roundup:ย https://lnkd.in/eU-bkith #FDAapproval #FDA #monoclonalantibody #pd1 #nasopharyngealcarcinoma #npc #medicalinnovation #loqtorzi #toripalimab #coherus #junshi #topalliance
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๐ Save the Date: Join LifeSci Events and Cidara Therapeutics for a virtual research and development day on September 21st at 12:00 PM EDT! Reserve your seat: https://lnkd.in/ePs2dP7J ๐ Featured Speakers: โ Jorge Villacian, MD & Penny Heaton, MD from Janssen Pharmaceuticals will present Phase 2a data on CD388 (JNJ-0953), a promising drug candidate aimed at the universal prevention of seasonal flu. โ Stephen Schoenberger, PhD of La Jolla Institute for Immunology will shed light on the unmet needs in cancer immunotherapy. โ Ezra Cohen, MD, CMO at Tempus, will discuss the emerging significance of drug-Fc conjugates (DFCs) in precision oncology. The leadership team from Cidara will also share exciting updates on its Cloudbreakยฎ pipeline focusing on oncology DFCs, and offer insights into clinical development considerations for DFCs targeting solid tumors. ๐ค Live Q&A: Stay tuned for a live Q&A session where you can get your questions answered by these industry leaders! #InfluenzaPrevention #CancerImmunotherapy #DrugDevelopment #Pharmaceuticals #InfectiousDiseases #Oncology #PrecisionMedicine #LifeSciEvent #LifeSciences
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2seventy bio and Bristol Myers Squibb "are expanding their Abecma treatment site footprint to help more patients access the treatment, 2seventy said. Part of that push will include renewed physician educationโespecially on treatment sequencing and the emerging data supporting the use of BCMA-directed CAR-Ts before other BCMA-targeted therapies. Further, 2seventy wants to help doctors recognize the significance of Abecmaโs real-world safety and efficacy." The former is anticipating FDA's decision for Abecma which could potentially move it to 3L use, as it is currently approved as 5L therapy. 2Seventy will also pass along their R&D assets to Regeneron #2SeventyBio #Biotech #Pharma #BMS #BristolMyersSquibb #CART #CellTherapy #AdvancedTherapeutics #Abecma #Innovation #Cancer #Oncology #Healthcare
Amid strategic pivot, 2seventy bio plots comeback for BMS-partnered CAR-T Abecma
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Didnโt get a chance to talk to us at #ASH2023? Read the first part of our latest blog series โOld biomarkers, new tricksโ which discusses our insights from the December meeting! Leila Luheshi, VP Pharma Partnering, describes the potential of menin inhibitors for acute leukemia, including the use of IVDR approved FISH probes in clinical trials. Read Part 1 of this series here: https://lnkd.in/gCxMefme
OGTโs insights from ASH 2023: Part 1 | OGT blog
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https://lnkd.in/gZ-4nBx7 Key Insights: โข MARIPOSA marks the third RYBREVANTยฎ Phase 3 study to readout this year following PAPILLON and MARIPOSA-2 โข It received accelerated approval from the USFDA in May 2021 for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has specific EGFR exon 20 insertion mutations, as determined by an FDA-approved test Visit MedicoInsights to explore key insights #NSCLCย #cancerย #knowledgeย #lymphomaย #HealthTrendsย #Insightsย #HealthIndustryย #HealthInnovationย #latestnewsย #HealthcareAnalyticsย #NewsUpdateย #HealthcareNetworkingย #pharmaย #pharmaceuticalsย #pharmanewsย #pharmaindustryย #pharmainnovationย #updateย #medicoinsightsย #newsย #pharmaย #healthย #dailynews
Landmark Phase 3 MARIPOSA Study Meets Primary Endpoint Resulting in Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival for RYBREVANTยฎ (amivantamab-vmjw) plus Lazertinib Versus Osimertinib in Patients with EGFR-Mutated NSCLC | MedicoInsights
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