Market Access Today’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

The Phase Ib study (NCT04894825) of FutureGen Laboratories’s FG-M108 combined with chemotherapy in advanced pancreatic cancer shows promise. With 46 patients treated, the 300 mg/m³ dose had a 33.3% ORR and the 600 mg/m³ dose had a 30% ORR, both achieving a 100% DCR. Despite all patients experiencing TEAEs, the safety profile is favorable. Further evaluation of PFS and OS will determine long-term benefits. Unlock In-Depth Expert Insights and Analysis with DelveInsight Business Research LLP's Exclusive American Society of Clinical Oncology (ASCO) 2024 Reporting: https://lnkd.in/gWptYZp2 #ASCO24 #CancerTreatment #ASCO2024 #LungCancer #NSCLC #mCRPC #PharmaInnovation #MedicalResearch #OncologyAdvancements #ClinicalOncology #Pharmaceuticals #HealthcareConference #CancerResearch #ClinicalPractice #MedicalBreakthroughs #CancerCare #PharmaLeaders

Breakthrough in Pancreatic Cancer: FDA Endorses Ipsen’s Onivyde as First-Line Treatment Onivyde, a treatment for pancreatic cancer, has been approved by the FDA for first-line treatment, potentially changing the way metastatic pancreatic adenocarcinoma is managed. The drug, also known as pegylated liposomal irinotecan, is now approved for use in combination with the NALIRIFOX regimen. This marks the first new treatment option for previously untreated patients in over a decade. The approval is based on the results of the NAPOLI-3 study, which showed improved overall survival and progression-free survival compared to the standard treatment regimen. Ipsen, the company behind Onivyde, sees this approval as an opportunity to reach a wider patient population and a significant advancement in managing the disease. For more details please click the link! https://lnkd.in/dmvSjqf7 #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical

Breakthrough in Esophageal Cancer Treatment: FDA Greenlights Tevimbra as Second-Line Monotherapy The FDA has approved tislelizumab-jsgr (marketed as Tevimbra) for use as second-line monotherapy in certain adult patients with unresectable or metastatic esophageal cancer who have previously undergone chemotherapy without a PD-L1 inhibitor. The approval is based on the phase 3 RATIONALE 302 trial, which showed that tislelizumab improved overall survival and had a favorable safety profile compared to chemotherapy. Tislelizumab demonstrated enhanced overall response rates and longer-lasting responses. Common adverse reactions included changes in glucose levels, hemoglobin levels, lymphocyte counts, and more. The approval of tislelizumab marks a significant milestone in the treatment of advanced esophageal cancer and holds promise for patients. The FDA is also reviewing an application for tislelizumab as a first-line treatment option for other types of cancer. For more details please click the link! https://lnkd.in/dnaQEZE4 #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical

Johnson & Johnson’s TAR-200 Granted FDA Breakthrough Status for High-Risk Bladder Cancer Johnson & Johnson has received FDA Breakthrough Therapy Designation for TAR-200, a treatment for high-risk non-muscle-invasive bladder cancer patients. TAR-200 aims to deliver gemcitabine into the bladder and has potential to revolutionize bladder cancer treatment. The designation recognizes the innovation of TAR-200 and its potential to reshape bladder cancer treatment. The designation is backed by data from the SunRISe-1 study, which has shown promising interim results for TAR-200 in BCG-unresponsive HR-NMIBC patients. The study aims to evaluate TAR-200's effectiveness and secondary outcomes in different treatment cohorts. TAR-200 is currently undergoing Phase 2 and Phase 3 evaluations. For more details please click the link! https://lnkd.in/duuykna8 #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

Potential answer to the opioid crisis, from which cancer patients living with chronic pain suffer? I came up with this idea over ten years ago to use EGFR inhibitors, which are already used in oral cancer treatment, to treat pain and opioid tolerance in oral cancer patients. I'm so glad my friend Dr. Yi Ye saw it to fruition. Check out our latest publication in MDPI Pharmaceuticals, which details our study funded by  National Institute of Dental and Craniofacial Research (NIDCR) Helping to End Addiction Long-term (HEAL) Initiative R01. Loma Linda University MD Anderson Cancer Center New York University

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

#ADC #antibodydrugconjugate New Phase 3 data evaluating sacituzumab tirumotecan (sac-TMT), an investigational TROP2-directed antibody-drug conjugate, in previously treated locally recurrent or metastatic triple-negative breast cancer First presentation of Phase 2b three-year follow-up data evaluating mRNA-4157 (V940), an investigational individualized neoantigen therapy, in combination with KEYTRUDA® (pembrolizumab) in patients with high-risk stage III/IV melanoma following complete resection