August 2, 2023

European Commission approves Trodelvy to treat unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer patients who have received endocrine-based therapy – Gilead Sciences

Gilead Sciences, Inc. announced that the European Commission (EC) approved Trodelvy (sacituzumab govitecan) as a monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting. The approval by the European Commission follows the positive opinion of the […]

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July 24, 2023

First-line Opdivo plus chemotherapy provides survival benefit in metastatic urothelial carcinoma (bladder cancer) – BMS

Frontline treatment with the combination of nivolumab (Opdivo) and cisplatin-based chemotherapy, followed by nivolumab monotherapy, led to a statistically significant improvement in progression-free survival (PFS) and overall survival (OS) compared with standard cisplatin-based chemotherapy regimens alone in previously untreated, cisplatin-eligible patients with unresectable or metastatic urothelial carcinoma, according to data from the phase III CheckMate-901 trial (NCT03036098). The study met […]

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July 21, 2023

European Commission grants conditional approval for Lytgobi to treat cholangiocarcinoma – Taiho Oncology Europe

Taiho Pharmaceutical and its subsidiary Taiho Oncology Europe have received conditional marketing authorisation from the European Commission for Lytgobi (futibatinib) tablets to treat adults with cholangiocarcinoma (CCA). The authorisation is based on the data from the global, open label FOENIX-CCA2 trial. It enrolled a total of 103 adult patients from the Netherlands, UK, Spain, Italy, France, and Germany. Patients with […]

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July 16, 2023

European Commission approves Opdivo + chemotherapy for neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients with tumor cell PD-L1 expression greater than 1% – BMS

Bristol Myers Squibb announced that the European Commission (EC) has approved Opdivo (nivolumab) in combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adult patients with tumor cell PD-L1 expression greater than 1%. With this EC decision, Opdivo with chemotherapy becomes the first neoadjuvant immunotherapy-based treatment option approved […]

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June 22, 2023

FDA approves Columvi, the first and only bispecific antibody with a fixed-duration treatment for people with relapsed or refractory diffuse large B-cell lymphoma – Roche

Roche announced that the FDA has approved Columvi (glofitamab-gxbm) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response […]

admin Health 0 3 min read
June 15, 2023

European Commission approval for Pedmarqsi to reduce the risk of hearing loss in paediatric oncology patients – Fennec Pharma

Fennec Pharmaceuticals Inc.has announced Pedmarqsi– known as Pedmark in the U.S. – was granted marketing authorization by the European Commission. Pedmarqsi is the first and only approved therapy in the EU for the prevention of ototoxicity (hearing loss) induced by cisplatin chemotherapy in patients 1 month to less than 18 years of age with localised, non-metastatic, solid tumors. Further, Pedmarqsi […]

admin Health 0 2 min read
June 12, 2023

Presentation of longer-term data for Tecvayli showing a duration of response of 22 months in patients with r/r multiple myeloma – Janssen

The Janssen Pharmaceutical Companies of Johnson & Johnson announced long-term data from the pivotal Phase 1/II MajesTEC-1 study showing the sustained efficacy and safety of Tecvayli (teclistamab-cqyv) in the treatment of patients with relapsed or refractory multiple myeloma (RRMM) who are triple-class exposed and previously received treatment with three or more prior lines of therapy. These results showed that nearly […]

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June 10, 2023

Kisqali significantly reduced the risk of recurrence by 25% across a broad population of patients with early breast cancer; clinically meaningful benefit was consistent .across subgroups – Novartis

Novartis presents positive primary endpoint data from the pivotal Phase III NATALEE trial at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting . Data showed that Kisqali (ribociclib) plus endocrine therapy (ET), compared to ET alone, lowered the risk of cancer recurrence by 25.2% in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative […]

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June 7, 2023

Keytruda + chemotherapy before surgery and continued as a single agent after surgery reduced the risk of event-free survival events by 42% versus pre-operative chemotherapy in resectable Stage II, IIIA or IIIB NSCLC – Merck Inc

Merck known as MSD outside of the United States and Canada, announced positive results from the pivotal Phase III KEYNOTE-671 trial evaluating Keytruda, Merck’s anti-PD-1 therapy, as a perioperative treatment regimen, which includes treatment before surgery (neoadjuvant) and after surgery (adjuvant), for patients with resectable stage II, IIIA or IIIB non-small cell lung cancer (NSCLC). After a median follow-up of […]

admin Health 0 2 min read
May 9, 2023

New ACR Breast Cancer Screening Guidelines call for earlier and more-intensive screening for high-risk women

New American College of Radiology® (ACR®) breast cancer screening guidelines now call for all women — particularly Black and Ashkenazi Jewish women — to have risk assessment by age 25 to determine if screening earlier than age 40 is needed. The ACR continues to recommend annual screening starting at age 40 for women of average risk, but earlier and more intensive screening for high-risk patients. The new […]

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