OMAKASE CONSULTING’s Post

📢 𝗡𝗲𝘄 𝘁𝗵𝗲𝗿𝗮𝗽𝗲𝘂𝘁𝗶𝗰 𝗽𝗼𝘀𝗶𝘁𝗶𝗼𝗻𝗶𝗻𝗴 𝗿𝗲𝗽𝗼𝗿𝘁𝘀 (𝗧𝗣𝗥𝘀) 𝗽𝘂𝗯𝗹𝗶𝘀𝗵𝗲𝗱 𝗶𝗻 𝗦𝗽𝗮𝗶𝗻: ⁣⁣ ⁣ - 𝗧𝗿𝗮𝘀𝘁𝘂𝘇𝘂𝗺𝗮𝗯 𝗱𝗲𝗿𝘂𝘅𝘁𝗲𝗰𝗮𝗻 (Enhertu®) in the treatment of adult patients with advanced non-small cell lung cancer (NSCLC). ⁣ 𝗙𝗼𝗿 𝗰𝗼𝗺𝗽𝗹𝗲𝘁𝗲 𝗶𝗻𝗱𝗶𝗰𝗮𝘁𝗶𝗼𝗻: https://lnkd.in/dSndmPHC ⁣ - 𝗘𝗺𝗽𝗮𝗴𝗹𝗶𝗳𝗹𝗼𝘇𝗶𝗻 (Jardiance®) in the treatment of chronic kidney disease in adults.⁣ 𝗟𝗶𝗻𝗸: https://lnkd.in/dZS2_aBc - 𝗣𝗲𝗺𝗯𝗿𝗼𝗹𝗶𝘇𝘂𝗺𝗮𝗯 (Keytruda®) in combination with chemotherapy for the first-line treatment of locally advanced unresectable or metastatic HER-2 negative HER-2 negative gastric or gastroesophageal junction adenocarcinoma in adults.⁣ 𝗙𝗼𝗿 𝗰𝗼𝗺𝗽𝗹𝗲𝘁𝗲 𝗶𝗻𝗱𝗶𝗰𝗮𝘁𝗶𝗼𝗻: https://lnkd.in/d6Na2NBN ⁣ - 𝗠𝗼𝗺𝗲𝗹𝗼𝘁𝗶𝗻𝗶𝗯 (Omjjara®) in the treatment of splenomegaly or disease-related symptoms in adult patients with moderate to severe anemia.⁣ 𝗙𝗼𝗿 𝗰𝗼𝗺𝗽𝗹𝗲𝘁𝗲 𝗶𝗻𝗱𝗶𝗰𝗮𝘁𝗶𝗼𝗻: https://lnkd.in/dgBrNSpH - 𝗡𝗶𝘃𝗼𝗹𝘂𝗺𝗮𝗯-𝗿𝗲𝗹𝗮𝘁𝗹𝗶𝗺𝗮𝗯 (Opdualag®) in the first-line treatment of advanced melanoma (unresectable or metastatic) in adults and adolescents 12 years of age and older with PD-L1 expression < 1% in tumor cells.⁣ 𝗟𝗶𝗻𝗸: https://lnkd.in/dmZsH7JZ ⁣ - 𝗤𝘂𝗶𝘇𝗮𝗿𝘁𝗶𝗻𝗶𝗯 (Vanflyta®) in combination with standard induction chemotherapy with cytarabine and anthracycline and standard consolidation chemotherapy with cytarabine.⁣ 𝗙𝗼𝗿 𝗰𝗼𝗺𝗽𝗹𝗲𝘁𝗲 𝗶𝗻𝗱𝗶𝗰𝗮𝘁𝗶𝗼𝗻: https://lnkd.in/da5d7b8G ⁣ - 𝗥𝗶𝘃𝗮𝗿𝗼𝘅𝗮𝗯𝗮𝗻 (Xarelto®), in combination with acetylsalicylic acid, in the prevention of atherothrombotic events in adults.⁣ 𝗟𝗶𝗻𝗸: https://lnkd.in/dQD9NcQ8 ⁣ - 𝗕𝗮𝗿𝗶𝗰𝗶𝘁𝗶𝗻𝗶𝗯 (Olumiant®) in severe alopecia areata.⁣ 𝗟𝗶𝗻𝗸: https://lnkd.in/dsYUMmgp ⁣ - 𝗘𝗹𝗿𝗮𝗻𝗮𝘁𝗮𝗺𝗮𝗯 (Elrexfio®) in treatment of adult patients with relapsed and refractory multiple myeloma. ⁣ 𝗙𝗼𝗿 𝗰𝗼𝗺𝗽𝗹𝗲𝘁𝗲 𝗶𝗻𝗱𝗶𝗰𝗮𝘁𝗶𝗼𝗻: https://lnkd.in/dxQiu8PY ⁣ - 𝗣𝗲𝗺𝗯𝗿𝗼𝗹𝗶𝘇𝘂𝗺𝗮𝗯 (Keytruda®) in combination with trastuzumab, and fluoropyrimidine- and platinum-based chemotherapy for the first-line treatment of locally advanced unresectable or metastatic HER-2 positive gastric or gastroesophageal junction adenocarcinoma in adults.⁣ 𝗙𝗼𝗿 𝗰𝗼𝗺𝗽𝗹𝗲𝘁𝗲 𝗶𝗻𝗱𝗶𝗰𝗮𝘁𝗶𝗼𝗻: https://lnkd.in/d8rcUmwz ⁣ - 𝗠𝗲𝗹𝗽𝗵𝗮𝗹𝗮𝗻 𝗳𝗹𝘂𝗽𝗵𝗲𝗻𝗮𝗺𝗶𝗱𝗲 (Pepaxti®) in combination with dexamethasone, in the treatment of adult patients with multiple myeloma.⁣ 𝗙𝗼𝗿 𝗰𝗼𝗺𝗽𝗹𝗲𝘁𝗲 𝗶𝗻𝗱𝗶𝗰𝗮𝘁𝗶𝗼𝗻: https://lnkd.in/dZU5xgSV ⁣ - 𝗢𝗺𝗮𝘃𝗲𝗹𝗼𝘅𝗼𝗹𝗼𝗻𝗲 (Skyclarys®) in Friedreich's Ataxia.⁣ 𝗟𝗶𝗻𝗸: https://lnkd.in/dGuxYFtd - 𝗧𝗮𝗹𝗾𝘂𝗲𝘁𝗮𝗺𝗮𝗯 (Talvey®) in monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma.⁣ 𝗙𝗼𝗿 𝗰𝗼𝗺𝗽𝗹𝗲𝘁𝗲 𝗶𝗻𝗱𝗶𝗰𝗮𝘁𝗶𝗼𝗻: https://lnkd.in/dsf8Ukt3 ⁣ ⁣ #Pharmaceuticals #AEMPS #TPR #MarketAccess #Spain⁣ ⁣

BCN HEALTH | AEMPS publishes 5 new IPTs in Oncology, rare diseases, cardiovascular diseases and SMA #health #AEMPS #anemia #bevacizumab #prostatecancer #carboplatin #cardiovascular #cisplatin #efficacy #eculizumab #rarediseases #SMA #hypercholesterolemia #IPT #oncology #paclitaxel #medicaldevices #chemotherapy #safety #tolerability https://lnkd.in/dZGCbFij

#Clinicalfindings #dermatologists #Oncologist 1. Genmab and Seagen (Acquired by Pfizer): This #phase3 trial compared #tisotumab #vedotin monotherapy to chemotherapy as a second or third-line treatment for recurrent or metastatic cervical #cancer. The study involved 502 patients randomly assigned to either treatment group. Results showed that #tisotumab #vedotin significantly improved overall survival (11.5 vs 9.5 months), progression-free survival (4.2 vs 2.9 months), and objective response rate (17.8% vs 5.2%) compared to chemotherapy. with a lower rate of grade 3 or greater events. The study concluded that #tisotumab #vedotin demonstrated significantly greater efficacy than chemotherapy in patients with recurrent cervical cancer, offering a promising new treatment option for this life-threatening disease. https://lnkd.in/g_Pj-vDm 2. Ionis Pharmaceuticals, Inc. This #phase3, double-blind, randomized trial evaluated the efficacy of #donidalorsen, an antisense oligonucleotide that reduces prekallikrein expression, for long-term prophylaxis in patients with hereditary #angioedema. The study compared #donidalorsen administered subcutaneously every 4 or 8 weeks to placebo. Results showed that #donidalorsen significantly reduced the hereditary angioedema attack rate compared to placebo, with the 4-week dosing regimen demonstrating an 81% lower attack rate and the 8-week regimen showing a 55% lower rate. Additionally, patients receiving #donidalorsen every 4 weeks experienced significant improvements in quality of life. The treatment was generally well-tolerated, with most adverse events being mild to moderate. These findings support the potential use of #donidalorsen as a prophylactic treatment for hereditary #angioedema. https://lnkd.in/gY8FT3BJ 3. KalVista Pharmaceuticals, Inc. This #phase3, double-blind, three-way crossover trial evaluated the efficacy of #oral #sebetralstat (300 mg or 600 mg) compared to placebo for treating hereditary #angioedema attacks in 136 participants. The study found that both doses of #sebetralstat provided significantly faster times to the beginning of symptom relief, reduction in attack severity, and complete attack resolution compared to placebo. The 300-mg and 600-mg doses showed median times of 1.61 and 1.79 hours, respectively, for the beginning of symptom relief, compared to 6.72 hours for placebo. Additionally, a higher percentage of attacks achieved complete resolution within 24 hours with #sebetralstat (42.5% for 300 mg and 49.5% for 600 mg) compared to placebo (27.4%). Sebetralstat demonstrated a safety profile similar to placebo, with no serious adverse events reported, suggesting it could be an effective and well-tolerated oral treatment option for hereditary #angioedema attacks. https://lnkd.in/gEGUPxq5 #dermatologists #Oncologist #KOLs

🔬🌱 𝐄𝐱𝐩𝐥𝐨𝐫𝐢𝐧𝐠 𝐭𝐡𝐞 𝐁𝐚𝐬𝐚𝐥 𝐂𝐞𝐥𝐥 𝐂𝐚𝐫𝐜𝐢𝐧𝐨𝐦𝐚 (𝐁𝐂𝐂) 𝐓𝐡𝐞𝐫𝐚𝐩𝐞𝐮𝐭𝐢𝐜𝐬 𝐌𝐚𝐫𝐤𝐞𝐭: 𝐀𝐝𝐯𝐚𝐧𝐜𝐞𝐦𝐞𝐧𝐭𝐬 𝐢𝐧 𝐒𝐤𝐢𝐧 𝐂𝐚𝐧𝐜𝐞𝐫 𝐓𝐫𝐞𝐚𝐭𝐦𝐞𝐧𝐭 𝐚𝐧𝐝 𝐃𝐞𝐫𝐦𝐚𝐭𝐨𝐥𝐨𝐠𝐢𝐜𝐚𝐥 𝐂𝐚𝐫𝐞 🌟🩺 𝐂𝐥𝐢𝐜𝐤 𝐇𝐞𝐫𝐞, 𝐓𝐨 𝐆𝐞𝐭 𝐅𝐫𝐞𝐞 𝐒𝐚𝐦𝐩𝐥𝐞 𝐑𝐞𝐩𝐨𝐫𝐭 https://lnkd.in/guntcp2b 🔍 Key Highlights: Skin Cancer Prevalence: Basal Cell Carcinoma (BCC) ranks among the most prevalent types of skin cancer globally, accounting for the majority of non-melanoma skin cancer diagnoses. While typically slow-growing and rarely metastatic, BCC can cause significant morbidity and disfigurement if left untreated, underscoring the importance of early detection, prompt intervention, and comprehensive management strategies in dermatological practice. Treatment Landscape: The Basal Cell Carcinoma Therapeutics Market offers a diverse array of treatment options tailored to individual patient needs, tumor characteristics, and disease stage. Standard treatment modalities for BCC include surgical excision, Mohs micrographic surgery, cryotherapy, electrodessication and curettage (ED&C), topical therapies, and radiation therapy, each with unique indications, efficacy profiles, and cosmetic outcomes. Emerging therapeutic approaches, such as hedgehog pathway inhibitors, immunotherapies, photodynamic therapy, and targeted molecular therapies, are expanding the treatment armamentarium for advanced, recurrent, or high-risk BCC cases, offering new hope for patients with aggressive or treatment-refractory disease. #Company Sun Pharmaceuticals Bausch Health Companies Inc. Mylan F. Hoffmann-La Roche Merck Group #Type Surgery Radiation Therapy Photodynamic Therapy Drugs #Application Retail Pharmacies Hospitals Pharmacies Cancer Research Institutes #BasalCellCarcinomaTherapeutics #Marketresearch #BasalCell #CarcinomaTherapeutics #Marketgrowth

In continuation of Alectinib approval, An implication on Treatment paradigm post Alcetinib approval The sanctioning of Alectinib (Alecensa) by the FDA as a supplementary treatment for early-stage ALK-positive non-small cell lung cancer (NSCLC) after surgery carries several transformative implications for existing treatment models: 1.#Transition to Precision Medicine: The endorsement represents a move away from conventional chemotherapy to precision medicine in the adjuvant context for patients with ALK-positive NSCLC, targeting the specific genetic alterations driving tumor growth. 2. #Improved Disease-free survival (DFS): The marked extension in the period patients remain free from disease with Alectinib, as opposed to chemotherapy, may establish it as the preferred post-operative treatment for ALK-positive NSCLC. The ALINA trial (NCT03456076) evidenced a substantial diminution in the risk of the disease returning or leading to death. 3. #Central Nervous System (CNS) protection: Alectinib has been shown to lower the risk of the disease recurring in the brain or causing death, which is vital considering the brain is often where lung cancer spreads first. 4. #Improved Patient Experience: Alectinib’s safety profile, characterized by mostly mild side effects and rare treatment discontinuations due to adverse reactions, indicates that it may offer a more favorable treatment experience than traditional chemotherapy. 5.#Extended Duration of Therapy: Patients are advised to continue treatment with Alectinib for two years or until the return of the disease or the onset of intolerable side effects, a duration that exceeds that of standard adjuvant chemotherapy regimens. In essence, the FDA’s approval of Alectinib is poised to alter the conventional approach to treating early-stage ALK-positive NSCLC, providing a more efficacious and potentially more agreeable alternative to traditional chemotherapy. It underscores the growing role of individualized treatment in cancer care. #oncology #clinicaltrials #cancer #treatment Prof.Humaid Al-Shamsi MB(IRL),FRCP(Lon),FRCP(Ca),FRCP(Glasgow),FACP(US) Dr. Simran Sethi

Interesting read: Increased keratinocyte activity and PIEZO1 signaling contribute to paclitaxel-induced mechanical hypersensitivity. The team has shown that the chemotherapeutic drug paclitaxel activates the mechanoreceptor PIEZO1 in keratinocytes from mice and humans, while the deletion of PIEZO1 in keratinocytes alleviates touch hypersensitivity in mice. These important results pave the way for the development of novel agents for the treatment of chemotherapy-induced neuropathy that target PIEZO1 in epidermal keratinocytes, potentially via noninvasive topical treatments. This would have the potential to reduce paclitaxel-related side effects in other organs and enhance the efficacy of cancer therapy. Read the complete publication here: https://lnkd.in/g8bRGQW6 #DrugDevelopment #Pain #Chemotherapy #Neuropathy #PainRelief 

#FDA Approval of #Alectinib: A New Horizon in Adjuvant Therapy for Early-Stage #ALK-Positive NSCLC 1. #Approval date: Alectinib received the FDA’s nod for use as an additional therapy for ALK-positive NSCLC on April 18, 2024. This is specifically for patients who have undergone surgical removal of their tumor and are in the early stages of lung cancer. 2. #Treatment Indication: The sanction is aimed at those who have had ALK-positive NSCLC surgically excised, particularly targeting the early stages post-operation. 3. #Clinical Trial: The drug’s effectiveness was validated in a worldwide, randomized, open-label study known as ALINA (NCT03456076), which involved participants with resectable Stage IB (tumors of at least 4 cm) to IIIA #NSCLC. 4. #Survival Without Disease Progression (DFS): In this study, individuals with stage II-IIIA NSCLC who were treated with Alectinib showed a median survival without disease progression that surpassed the 44.4 months observed in those receiving chemotherapy, indicating a 76% decrease in the risk of the disease returning or leading to death. 5. #Recommended Dosage: It is advised that Alectinib be taken at a dose of 600 mg orally, twice a day alongside food, and continued for two years or until the patient experiences a recurrence of the disease or cannot tolerate the side effects. 6. #Adverse Effects: The typical side effects observed in patients on Alectinib include liver toxicity, bowel sluggishness, muscle pain, COVID-19, exhaustion, skin reactions, and respiratory issues. With this authorization, there’s a notable progression in the management of early-stage ALK-positive NSCLC, providing a therapy that zeroes in on the cancer’s specific traits, which could enhance outcomes for patients after surgery. Source: For an in-depth look at the prescribing details, the FDA’s complete information can be consulted. #oncology #FDA #LUNGCANCER #NSCLC #CLINICALTRIALS #DRUGAPPROVAL

A rare cause to celebrate in a rare type of cancer...but will profits trump science? A study published in this week's edition of the NEJM (https://lnkd.in/ehaKy6dS) reports on the effectiveness of combining two drugs, doxorubicin and trabectedin, in treating leiomyosarcoma, a type of soft tissue sarcoma. The Phase 3 trial involved 150 leiomyosarcoma patients, randomly assigned to receive either doxorubicin alone or a doxorubicin-trabectedin combination with trabectedin maintenance therapy for the combination group. (Trabectedin is sold under the brand name Yondelis by PharmaMar S.A. and Johnson and Johnson) The study found that patients who received the doxorubicin-trabectedin combination had significantly longer progression-free survival (PFS) and overall survival (OS) compared to those who received doxorubicin alone (12.2 vs. 6.2 months and 33 vs. 24 months, respectively). While the doxorubicin-trabectedin combination also had a higher incidence of adverse events, particularly hematologic toxicities, the findings were rightly hailed as "a late-arriving but welcome advance in sarcoma therapy" in the corresponding NEJM editorial (https://lnkd.in/eQAY32pC). As the editorial points out, "advances in therapy for soft-tissue sarcomas are difficult. Sarcomas are rare, accounting for less than 2% of all cancers. Large studies are difficult to conduct in small patient populations, and small but meaningful improvements cannot be shown in small studies." In addition to leiomyosarcoma, the editorial notes that this regimen should be studied in other sarcoma subtypes known to be sensitive to trabectedin but, given how long it took to get to this point and with market exclusivity expired (EU) or set to expire in 2028 (US), neither PharmaMar nor JNJ have the financial incentive to support such trials. While at first I questioned whether generic manufacturers could even be bothered with such a difficult-to-make product (https://lnkd.in/eE__qVCA) that has failed to live up to its once-lofty commercial projections (https://lnkd.in/ehfDQ36f), PharmaMar has indeed confirmed eroded sales due to entry of generic competition (https://lnkd.in/ez92-tWE.). So yes, profits may trump science in this case unless academic investigators - and payers - are willing to foot the bill for future studies with very high likelihoods of success. One can only hope.

Cannabinoids like nabiximols show promise in pain management for patients with advanced cancer. A systematic review of 10 studies with 1,169 participants found clinical improvements in pain control when used as an adjunct to opioids. However, evidence on their impact on quality of life (QoL) is inconclusive, and no consistent opioid-sparing effect has been demonstrated. The findings call for expanded research to better understand the role of cannabinoids in cancer care, especially given the growing need for innovative solutions to chronic and progressive diseases. Read more about the study: https://bit.ly/3VoYHxf #Cannabinoids #CancerCare #PainManagement #OpenScience

“Existing therapies often fall short, leaving patients with limited options. Our partnership with Sheba Medical Center is a step toward changing that,” says Dr. Oren Hershkovitz, CEO of Enlivex Therapeutics. Sheba Medical Center and Enlivex Therapeutics have joined forces to launch a Phase I clinical trial for Allocetra, an innovative cell therapy designed to address the unmet needs of patients with temporomandibular joint (TMJ) osteoarthritis. By restoring immune balance, Allocetra aims to provide long-term relief and improve quality of life for patients who haven’t responded to conventional treatments. Through this collaboration, Sheba continues its mission to transform care and lead the way in medical innovation. Learn more about this groundbreaking trial: https://lnkd.in/dmChR8GQ