FDA grants priority review to application for Keytruda + concurrent chemoradiotherapy, as treatment for newly diagnosed high-risk locally advanced cervical cancer – Merck Inc

Merck Inc., known as MSD outside of the United States and Canada, announced the FDA has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking approval for Keytruda, Merck’s anti-PD-1 therapy, in combination with external beam radiotherapy (EBRT) plus concurrent chemotherapy, followed by brachytherapy (also known as concurrent chemoradiotherapy) as treatment with definitive intent for newly diagnosed […]

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 […]

Immunotherapy drug did not increase surgery complications, study finds

A University of Cincinnati study found administering an immunotherapy drug before surgery for oral cavity cancer did not lead to increased rates of complications during and after surgery. The findings were published Aug. 25 in the journal JAMA Otolaryngology — Head & Neck Surgery. Alice Tang, MD, first author on the study, said the research built upon previous findings led by […]

NICE UK recommends Keytruda with carboplatin and paclitaxel for metastatic squamous non-small-cell lung cancer – Merck Inc

NICE (UK): Keytruda (pembrolizumab), from Merck Inc. with carboplatin and paclitaxel is recommended as an option for untreated metastatic squamous non-small-cell lung cancer (NSCLC) in adults, only if their tumours express PD?L1 with a tumour proportion score of 0% to 49%, if their tumours express PD?L1 with a tumour proportion score of 50% or more and they need urgent clinical […]

European Commission approves Lenvima + Keytruda to treat endometrial carcinoma – Eisai + Merck Inc.

Eisai Co., Ltd. and Merck Inc., announced that the European Commission has approved the combination of Lenvima, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus Keytruda, the anti-PD-1 therapy from Merck Inc., for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum-containing therapy […]

FDA approves Keytruda plus chemotherapy for cervical cancer – Merck

Merck Inc., announced that the FDA has approved Keytruda (pembrolizumab) in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (Combined Positive Score [CPS] at least 1) as determined by an FDA-approved test. The approval is based on the Phase III KEYNOTE-826 trial evaluating Keytruda plus […]

EMA gives green light for six new medicines

A total of 67 new medicines have been approved by the European Medicines Agency (EMA) in 2021. This includes six new products backed by the watchdog’s key advisory body, the Committee on Human Medicinal Products (CHMP). The newly approved products are: Trodelvy (sacituzumab govitecan) for the treatment of unresectable or metastatic triple-negative breast cancer. Rybrevant (amivantamab), conditionally approved for the treatment of […]

Phase III KEYNOTE-394 trial of Keytruda meets primary endpoint in hepatocellular carcinoma – Merck Inc

Merck Inc announced that the Phase III KEYNOTE-394 trial investigating Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in Asian patients with advanced hepatocellular carcinoma (HCC) previously treated with sorafenib met its primary endpoint of overall survival (OS). The study found that treatment with Keytruda plus best supportive care resulted in a statistically significant improvement in OS compared with placebo plus best supportive […]

FDA approves Keytruda to treat high-risk early-stage triple-negative breast cancer – Merck Inc.

Merck Inc. announced that the FDA has approved Keytruda, Merck’s anti-PD-1 therapy, for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery, based on the Phase III KEYNOTE-522 trial. TNBC is an aggressive type of breast cancer with an […]

Merck Inc provides update on Keytruda indication in third-line gastric cancer in the US

Copyright © ICR (UK) Limited t/a International Medical Information (IMI). Registered in the UK Company no. 05894351 medicalupdateonline.com is brought to you by International Medical Information. For more details, visit http://www.medicalimi.com Disclaimer: All information on this site has been collated by healthcare professionals from around the globe. Where every possible step has been taken to ensure its accuracy, MedicalUpdateOnline cannot […]