Camilla Fedi’s Post

AstraZeneca Tagrisso sNDA gains FDA priority review for lung cancer AstraZeneca oncology research and development executive vice-president Susan Galbraith stated: “Priority review of Tagrisso in this early-stage curative setting is important for patients who currently have no targeted treatments available. We look forward to close collaboration with the FDA on an accelerated path to bring Tagrisso to patients as a potential new standard of care as quickly as possible. Tagrisso continues to serve patients as a backbone therapy in EGFR-mutated lung cancer, extending progression-free survival in the LAURA trial by more than three years and reinforcing the importance of testing for EGFR mutations at the time of diagnosis.” - https://lnkd.in/d33ib_wi #pharma #oncology #lungcancer

🌟 JUST OUT 🌟 in Cancers MDPI! Proud to have contributed to this special issue, “Research on Targeted Drugs in Cancer”. Targeted therapies comprised the largest proportion of #oncology drugs approved by the FDA over the past 25 years, and have become standard of care for the treatment of many cancers. However, despite the transformation of the therapeutic landscape, #dosefinding methodology originally developed for cytotoxic chemotherapy drugs has continued to be employed during #drugdevelopment. In recognition of the need to adapt the dose selection process for modern #cancer therapies and design alternative strategies, the #FDA has undertaken several initiatives in recent years (including the launch of #ProjectOptimus in 2021 and the release of draft guidance for industry on #doseoptimization of oncology drugs in 2023). In this paper, I present case studies for 6 different targeted cancer therapies, highlighting how dose-finding challenges have been managed to date by oncologists, sponsors, and regulators. This manuscript is dedicated to the memory of Anne Loeser (founder of the Patient-Centered Dosing Initiative), and to all the other patient advocates working tirelessly to improve outcomes and quality of life for those living with cancer. https://lnkd.in/eKhEf4WF

Roche and Exelixis' Tecentriq-Cabometyx Combo Triumphs in Advanced Prostate Cancer Despite Past Setbacks Roche's Tecentriq and Exelixis' Cabometyx have made strides in treating challenging prostate cancer cases after clinical trial setbacks. Phase 3 CONTACT-02 trial achieved positive results, extending progression-free survival in pretreated metastatic castration-resistant prostate cancer patients. While one primary endpoint was met, overall survival displayed a promising trend. Safety profiles aligned with established standards. This success could revolutionize treatment, combining a tyrosine kinase inhibitor with immunotherapy. Ipsen's EVP Howard Mayer emphasized groundbreaking nature, raising hope for patients in advanced stages. Regulatory assessment and potential benefits lie ahead, holding promise for the challenging disease stage and turning the tide for the combination. For those looking to explore the full details of this breakthrough and stay updated on the Latest Pharma News, visit Pharmtales. #pharma #pharmaceutical #pharmtales #latestnews #pharmanews #pharmaceuticalindustry #pharmaceuticalcompanies #prostatecancer #cancer https://lnkd.in/d4z97X3H

Does the inclusion of biomarker analysis improve the success rates of clinical trial testing for new drugs? This study published in Cancer Medicine provides strong evidence that inclusion of biomarker analysis significantly improves success rates in oncology clinical trials. Strikingly, both validated and exploratory biomarker appeared to have a positive effect on drug trajectories through all clinical trial testing stages. The study analyzed the effect of predictive biomarker use in four oncology indications using multi‐state Markov models. The likelihood of drug approval with biomarkers increased nearly fivefold for all indications combined supporting the inclusion of biomarkers already at early stages in oncology clinical trials.  Read the full article here:

Breast Cancer Treatment Breakthrough: EMA Endorses AstraZeneca’s Truqap and Faslodex Combo AstraZeneca's combination therapy, Truqap with Faslodex, has received a positive recommendation from the European Medicines Agency for the treatment of advanced ER-positive, HER2-negative breast cancer. The therapy demonstrated a 50% reduction in the risk of disease progression or death compared to the standard treatment. It is effective across a diverse group of patients and targets treatment based on individual genetic markers. Final approval by the European Commission would set a new standard of care for these patients. The therapy has already been approved in Japan, the US, and other countries. For more details please click the link! https://lnkd.in/dwcYbRRv #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical

Arcus and Gilead Discontinue A2R, a Prostate Cancer Medication Arcus and Gilead Sciences cease etrumadenant development for castration-resistant prostate cancer (CRPC) due to lackluster efficacy but will continue testing for colorectal cancer (CRC). Their $2 billion alliance remains active, with data on etrumadenant for CRC expected in H1 next year. ARC-6 trial, examining etrumadenant with zimberelimab for metastatic CRPC, did not show sufficient benefits, while ARC-9's CRC study's results were postponed. Despite setbacks, positive outcomes were reported for domvanalimab plus zimberelimab in NSCLC, and quemliclustat showed "encouraging" results in pancreatic cancer. Arcus and Gilead position themselves in competition with other firms in these oncology fields. If you're interested in continuing to read the full story and want to stay updated with the Latest Pharma News in USA, visit Pharmtales. #pharma #pharmaceutical #pharmatles #latestnews #pharmanews #pharmaceuticalindustry #prostatecancer #arcus #gilead https://lnkd.in/d7FGy_aJ

𝐀𝐝𝐯𝐚𝐧𝐜𝐢𝐧𝐠 𝐓𝐫𝐞𝐚𝐭𝐦𝐞𝐧𝐭: 𝐏𝐟𝐢𝐳𝐞𝐫'𝐬 𝐀𝐝𝐜𝐞𝐭𝐫𝐢𝐬 𝐁𝐨𝐨𝐬𝐭𝐬 𝐒𝐮𝐫𝐯𝐢𝐯𝐚𝐥 𝐢𝐧 𝐃𝐢𝐟𝐟𝐮𝐬𝐞 𝐋𝐚𝐫𝐠𝐞 𝐁-𝐜𝐞𝐥𝐥 𝐋𝐲𝐦𝐩𝐡𝐨𝐦𝐚 𝐏𝐚𝐭𝐢𝐞𝐧𝐭𝐬 Pfizer Pfizer announced promising results from the Phase III ECHELON-3 study, showing that the antibody-drug conjugate Adcetris significantly improved survival rates in relapsed/refractory diffuse large B-cell lymphoma patients when combined with lenalidomide and rituximab. The study demonstrated a statistically significant and clinically meaningful improvement in overall survival compared to the lenalidomide and rituximab plus placebo group. Adcetris also showed positive outcomes in secondary endpoints like overall response rate and progression-free survival. Safety profiles were consistent with previous findings, reassuring regarding Adcetris' tolerability. Roger Dansey Roger Dansey, Pfizer's Chief Development Officer of Oncology, emphasized the potential of Adcetris in addressing the unmet needs of patients, even those previously treated with CAR-T therapy. Originally developed by Seagen in collaboration with Takeda, Adcetris targets the CD30 surface protein, carrying a toxic payload that triggers cell death in malignant cells while sparing healthy ones. Pfizer acquired access to Adcetris through its acquisition of Seagen in March 2023. Adcetris, initially approved for Hodgkin lymphoma and rare systemic anaplastic large cell lymphoma, has gained additional approvals for various treatment settings and patient populations in these cancers. Pfizer is expanding Adcetris' applications in Hodgkin lymphoma, peripheral T-cell lymphoma, non-small cell lung cancer, and melanoma. This progress aligns with Pfizer's broader strategy of focusing on four cancer types, including hematologic malignancies. The company aims to bolster its biologics business, anticipating it to constitute 65% of its cancer franchise by 2030, with the Seagen acquisition playing a significant role in achieving this target. In addition to Seagen Seagen, Pfizer has partnered with Nona Biosciences to develop the mesothelin-targeting ADC HBM9033 in solid tumors, further enriching its oncology pipeline. #Adcetris #DLBCL #CancerSurvival #OncologyResearch #MedicalBreakthroughs #Pfizer #ClinicalTrials #HealthcareInnovation

ImmunoGen, Inc.'s Recent Progress and Third Quarter 2023 Financial Results include these ANTICIPATED UPCOMING EVENTS: Potential FDA approval of ELAHERE’s sBLA in H1 2024. Report full data from the single-arm Phase 2 PICCOLO trial of mirvetuximab in FRα-high PSOC in mid-2024. Potential EMA approval of ELAHERE in late 2024 to support launch in Europe. Our partner, Huadong Medicine, is planning for NMPA approval of ELAHERE by the end of 2024 to support launch in China. Report data from the 802 trial, evaluating the pivekimab sunirine (pivekimab) triplet with Venclexta® (venetoclax) and Vidaza® (azacitidine) in frontline acute myeloid leukemia (AML) at the American Society of Hematology (ASH) Annual Meeting in December 2023. Report top-line data from the pivotal frontline de novo cohort in the Phase 2 CADENZA trial of pivekimab in blastic plasmacytoid dendritic cell neoplasm (BPDCN) in 2024. Provide an update on the IMGC936 non-small cell lung cancer (NSCLC) cohort following a prespecified interim analysis. https://lnkd.in/ewT4J2wc

Clinical Trials Updates: GSK's #endometrialcancer therapy is granted #fda approval, with a 71% reduction in risk of disease progression The FDA has approved GSK's drug Jemperli (dostarlimab) in combination with chemotherapy to treat adult patients with primary advanced or recurrent endometrial cancer that shows an inability to repair DNA, leading to the accumulation of mutations. For the treatment to be effective, the tumor must be mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H), features present in about 20-29% of endometrial cancers. Jemperli is a programmed death receptor-1 (PD-1)-blocking antibody that hinders the interaction between the PD-1 receptor and PD-L1 and PD-L2 ligands. The approval was based on data from Part 1 of the Phase III study, revealing a 71% reduction in the risk of disease progression or death in the studied population. Jemperli's approval represents a significant advancement in treating this type of endometrial cancer. Although the FDA-approved label is narrower than expected, the therapy holds promising potential and could potentially generate one billion dollars in revenue. click here to read the full article: https://lnkd.in/eWfYt5A3 #medicalaffairs #medicalcareers #regulatoryaffairs #clinicaldevelopment #medicalcareers #medicalprofessionals

Tivdak Demonstrates Survival Benefit in Phase 3 Cervical Cancer Trial by Seagen and Genmab Seagen's Tivdak, in collaboration with Genmab, has shown promising results in a pivotal phase 3 trial for recurrent or metastatic cervical cancer. Outperforming chemotherapy, Tivdak extended patient survival and demonstrated notable progression-free survival and objective response rates. The companies plan to seek full FDA approval, building on Tivdak's accelerated approval in 2021. This development coincides with Pfizer's pending $43 billion acquisition of Seagen, hinting at a transformative future in cervical cancer treatment. The findings have the potential to revolutionize clinical practice and expand Tivdak's role in treating other tumors expressing tissue factors. If you're interested in continuing to read the full story and want to stay updated with the Latest Pharma News in USA, visit Pharmtales. #pharma #pharmaceutical #pharmtales #latestnews #pharmanews #pharmaceuticalindustry #pharmaceuticalcompanies #cancertrial https://lnkd.in/dk4YWPri