News

EU approves Libtayo for cervical cancer

Read time: 1 mins

Published:23rd Nov 2022

Regeneron Pharmaceuticals announced that the European Commission (EC) approved Libtayo (cemiplimab) as monotherapy for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy

The EC approval in advanced cervical cancer is based on data from the global Phase III EMPOWER-Cervical 1 trial, which was conducted with the GOG Foundation, Inc. (GOG), the European Network for Gynaecological Oncological Trial groups (ENGOT) and NRG Oncology-Japan. The trial evaluated Libtayo in comparison to an investigator's choice of chemotherapy and enrolled 608 patients across 14 countries, irrespective of PD-L1 expression status or histology. In March 2021, the trial was stopped early based on the highly significant effect of Libtayo on overall survival (OS) among squamous cell carcinoma (SCC) patients following a unanimous recommendation by the Independent Data Monitoring Committee.

Condition: Cervical Cancer

Type: drug

Learning Zone Homepage

Supportive care in oncology Learning Zone

Supportive care in oncology from a multidisciplinary team involves caring for patients with cancer, treatment adherence and adverse effect management.

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.

Click here to view

Related news and insights

Drug news

FDA approves Alecensa (alectinib) as the first adjuvant treatment for people with ALK-positive early-stage lung cancer

Roche announced that the FDA has approved Alecensa (alectinib) for adjuvant treatment following tumour resection for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumours greater than 4 cm or node positive), as detected by an FDA-approved test

2 mins

Drug news

Iomab-B (apamistamab) to overcome high-risk TP53 mutation resulting in significant improvement in overall survival in patients with active relapsed refractory AML at the European Bone Marrow Transplant Annual Meeting

Actinium Pharmaceuticals, Inc. announced that results from the Phase III SIERRA trial of Iomab-B (apamistamab) were presented in an oral presentation at the 50th Annual European Bone Marrow Transplant Society Meeting (EBMT) held in Glasgow, Scotland on April 14-17

1 min

Drug news

FDA has granted a rolling New Drug Application (NDA) submission for suzetrigine (VX 548) in moderate-to-severe acute pain

Vertex Pharmaceuticals Incorporated announced important advancements across its suzetrigine pain program, which has the potential to be the first new class of medicine for acute and neuropathic pain in more than two decades. Suzetrigine is an oral selective NaV1.8 pain signal inhibitor (formerly known as VX-548)

1 min

See all news