Market Access Today’s Post

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

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

#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

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

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 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

Roche’s Phase II/III NSCLC treatment trial fails. Data from the Phase 2/3 SKYSCRAPER-06 study were not the ones expected to be, and Roche has to accept the disappointing result and move on. The study evaluated tiragolumab in combination with Roche’s PD-L1 inhibitor Tecentriq (atezolizumab) and chemotherapy as a first-line treatment for locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC). The tested therapy was compared to MSD’s PD-1 inhibitor Keytruda (pembrolizumab) and chemo in the trial. And Merck's Keytruda was a stronger performer than tiragolumab. Ah, Keytruda! The golden asset of Merck showed its superiority against Roche's candidate. Both endpoints, overall survival (OS) and progression-free survival (PFS) were not met. Bummer!

FDA Initiates Evaluation of Padcev/Keytruda Combination for Bladder Cancer Treatment The FDA is conducting a priority assessment of the combination treatment of Keytruda and Padcev for advanced bladder cancer. If approved, this treatment could provide an alternative to chemotherapy for all patients with advanced bladder cancer. The Keytruda/Padcev combination has already shown significant efficacy in reducing the risk of death and improving overall survival compared to chemotherapy. However, it may face competition from another treatment regimen involving Opdivo and standard chemotherapy. Other studies evaluating different treatment combinations are also underway. The expedited FDA review suggests a potential shift in the treatment landscape for advanced bladder cancer. For more details please click the link! https://lnkd.in/ggc4Mevb #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical

Mark your calendars for the 8th Annual MarketsandMarkets Next-Gen Immuno-Oncology Conference in London, endorsed by Medicon Valley Alliance as Our Supporting Association Partners. Join us on 07th-8th March 2024 at Park Plaza Victoria to explore the forefront of cancer immunotherapy To explore more, click here: https://lnkd.in/dvuWh2a6 #oncology #oncologyresearch #cancer #medicine #oncologia #immunooncology #healthcare #therapy #pharmaceutical #conference #marketsandmarkets  

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