KMK Consulting Inc.’s Post

Urothelial Cancer Treatments PADCEV® and KEYTRUDA® Were Validated Type II Variation Applications by EMA EMA has validated a Type II variation application for PADCEV® (enfortumab vedotin) in combination with KEYTRUDA® (pembrolizumab) as a first-line therapy for urothelial cancer. This combination therapy offers an alternative to platinum-containing chemotherapy and has shown significant improvements in overall survival and progression-free survival. The next steps involve review by the EMA's CHMP and EC. This therapy has already been approved by the FDA in the United States. The validation represents a promising step toward offering bladder cancer patients in Europe a new treatment option. For more details please click the link! https://lnkd.in/d-YV7rFS #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical

FDA Grants Approval to Augtyro™ (Repotrectinib) for ROS1-Positive Lung Cancer Bristol Myers Squibb has received FDA approval for Augtyro, a next-generation Tyrosine Kinase Inhibitor (TKI), as a treatment for ROS1-positive non-small cell lung cancer. Augtyro demonstrated high response rates and durable responses in clinical trials. The drug targets ROS1 oncogenic fusions and offers hope for patients with this rare form of lung cancer. The FDA approval is based on the successful results of the TRIDENT-1 trial. Augtyro comes with certain warnings and precautions, and is expected to be available to patients in the US in mid-December 2023. This approval is significant for precision medicine in lung cancer and provides hope for patients with ROS1-positive NSCLC. For more details please click the link! https://lnkd.in/gXdm6xdh #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical

Breaking News! 🎉 OBI Pharma's OBI-992 has received Orphan Drug Designation from the US FDA for treating gastric cancer, including gastroesophageal junction cancer. This designation encourages innovation for rare diseases, and we're thrilled to advance OBI-992 in our clinical trials. #OBIPharma #OrphanDrug #CancerResearch #Oncology #Biotech #Innovation https://lnkd.in/gmJyucen

Breaking News! 🎉 OBI Pharma's OBI-992 has received Orphan Drug Designation from the US FDA for treating gastric cancer, including gastroesophageal junction cancer. This designation encourages innovation for rare diseases, and we're thrilled to advance OBI-992 in our clinical trials. #OBIPharma #OrphanDrug #CancerResearch #Oncology #Biotech #Innovation https://lnkd.in/gmJyucen

#Melanoma_Cancer_Diagnostics Market Share Expected Huge Growth during 2022-2030 https://lnkd.in/dE8CtT8X The market for #melanoma cancer diagnostics is predicted to grow as the prevalence of melanoma skin #cancer rises. Increased exposure to ultraviolet radiation in factories, the sun, and other places eventually leads to increased melanoma skin cancer instances, propelling the melanoma cancer #diagnostic market forward. Inhalation Sciences Sweden AB Incyte Merck Group Novartis Pierre Fabre Group Amgen Amgen Deutschland AstraZeneca Bristol Myers Squibb Bristol Myers Squibb UK & Ireland Daiichi Sankyo, Inc.

As the 2024 American Society of Clinical Oncology (ASCO) annual meeting nears, anticipation mounts for the latest breakthroughs in cancer treatment. From May 31 to June 4, key figures in the industry will reveal new findings on various therapies. Major pharmaceutical players such as AbbVie, Gilead Sciences, Johnson & Johnson, Bristol Myers Squibb, Dizal Pharmaceutical, AstraZeneca, and others are poised to showcase highly anticipated results as ASCO 2024 approaches its conclusion, seizing the opportunity to showcase their advancements in lung cancer treatment. The event will feature a wealth of significant data on non-small cell lung cancer (NSCLC). The 2024 ASCO annual meeting is set to be a pivotal gathering for progress in managing lung cancer, with a multitude of studies expected to shape and revolutionize clinical approaches. Stay tuned with DelveInsight Business Research LLP for detailed ASCO 2024 coverage @ https://lnkd.in/gfN2QhBW #ASCO2024 #CancerResearch #LungCancer #OncologyAdvancements #PharmaceuticalInnovations #MedicalConference #ClinicalTrials #NSCLC #CancerTreatment #HealthcareUpdates

Should we consider them 2nd generation PARP inhibitors or a completely NEW class of drugs? - Vivek Subbiah, MD https://lnkd.in/gGfFz7G8 #oncodaily #oncology #cancer #PARP1 #PARPinhibitors #AACR24 #drugdevelopment #precisionmedicine #cancerresearch #biotechnology

A Milestone in Treating Ovarian Cancer: FDA Grants Full Approval to Elahere The FDA has granted full approval to Elahere, an antibody-drug conjugate (ADC), for the treatment of FRα-positive, platinum-resistant ovarian cancer. Elahere is the first and only ADC approved for this indication in the United States. The approval is seen as a significant breakthrough in the field of oncology and offers new hope for patients with this challenging malignancy. The SORAYA trial demonstrated Elahere's anti-tumor activity and tolerability, with 31.7% of patients achieving a confirmed objective response rate. The MIRASOL trial further supported Elahere's efficacy, showing superiority in overall survival and progression-free survival compared to chemotherapy. This approval marks a milestone in the treatment landscape for ovarian cancer and highlights the importance of targeted therapies in addressing unmet medical needs. For more details please click the link! https://lnkd.in/dm_-PYut #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical

Day One Biopharmaceuticals has secured an exclusive license for DAY301 through a significant $1.2B deal with MabCare Therapeutics. This strategic partnership, fueled by a substantial $55M upfront investment, aims to transform the landscape of cancer therapy for individuals, both adults and children, challenged by solid tumors. 💊 DAY301 is an advanced antibody-drug conjugate (ADC) that targets PTK7 and has displayed potential as a first-in-class treatment for multiple cancer types, including esophageal, ovarian, lung, endometrial cancers, and pediatric cancers such as neuroblastoma. Having achieved FDA investigational approval, Day One is swiftly advancing towards phase 1 clinical trials.🩺 This collaboration represents a key step in expanding Day One's therapeutic portfolio and underscores our commitment to research that directly benefits those affected by cancer. #CancerResearch #Biotechnology #HealthcareInnovation

Great news from Abbisko Therapeutics! The company has disclosed the preliminary first-in-human results of its next-generation highly selective FGFR2/3 inhibitor, ABSK061, during the 2024 European Society for Medical Oncology Targeted Anticancer Therapies Congress (ESMO TAT) held in Paris recently. As the world's first selective FGFR2/3 inhibitor undergoing human clinical trials, ABSK061 has exhibited impressive preliminary anti-tumor efficacy. Compared to previous pan-FGFR inhibitors, it has shown lower hyperphosphatemia and other side effects. Notably, multiple FGFR2/3-altered patients, including those diagnosed with lung, gastric, and other types of cancer, have responded positively to ABSK061 treatment. This progress paves the way for future applications of ABSK061 in treating not only cancer but also achondroplasia and other disorders. #QMportfolio #QMhealthcare #ESMOTAT #clinicalstudies #abbisko #ABSK061