CHMP issues positive opinion on Keytruda in NSCLC indication

Keytruda shows long-term survival benefit in NSCLC

Merck presented long-term data highlighting the sustained survival benefits of Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in treating non-small cell lung cancer at the European Society for Medical Oncology Congress 2025.

October 24, 2025

Vol.51 No.39

Drugs & Targets

CHMP adopts positive opinion for Libtayo as adjuvant treatment for high-risk CSCC

Regeneron Pharmaceuticals announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for Libtayo (cemiplimab) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation. Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells.

October 24, 2025

Vol.51 No.39

In Brief

Haystack Oncology, Rutgers Cancer Institute to test effectiveness of MRD assay in guiding post-surgery NSCLC treatment decisions

Haystack Oncology, a Quest Diagnostics company, and Rutgers Cancer Institute are partnering to evaluate the use of Haystack MRD, a circulating tumor DNA minimal residual disease test, to help optimize postoperative therapy decisions in patients with stage 2/3 non-small cell lung cancer.

September 26, 2025

Vol.51 No.35

Clinical Roundup

Libtayo + chemo shows significant improvement in OS for advanced NSCLC, phase III EMPOWER-Lung 3 trial shows

Libtayo (cemiplimab) plus chemotherapy demonstrates a more than double five-year overall survival rate of 19.4%, compared to 8.8% with chemotherapy alone, according to late-breaking data from exploratory analyses at World Conference on Lung Cancer.

September 19, 2025

Vol.51 No.34

Drugs & Targets

FDA grants Hernexeo Breakthrough Therapy designation as first line use for HER2-mutant advanced NSCLC

FDA granted Breakthrough Therapy designation to Hernexeos (zongertinib tablets) for first-line treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations.

September 12, 2025

Vol.51 No.33

In Brief

Arjan Gower receives NCCN grant to study a targeted therapy for early-stage NSCLC with rare EGFR mutations

Arjan Gower, a hematologist/oncologist at the UCLA Health Jonsson Comprehensive Cancer Center, received a $950,000 grant from the National Comprehensive Cancer Network and Taiho Oncology Inc. to help launch a multi-institutional clinical trial to test zipalertinib, an investigational drug that targets specific EGFR mutations, including Exon 20 insertions, which are known to drive cancer growth and resist standard treatments.

July 11, 2025

Vol.51 No.27

CHMP issues positive opinion on Keytruda in NSCLC indication

YOU MAY BE INTERESTED IN

Keytruda shows long-term survival benefit in NSCLC

CHMP adopts positive opinion for Libtayo as adjuvant treatment for high-risk CSCC

Haystack Oncology, Rutgers Cancer Institute to test effectiveness of MRD assay in guiding post-surgery NSCLC treatment decisions

Libtayo + chemo shows significant improvement in OS for advanced NSCLC, phase III EMPOWER-Lung 3 trial shows

FDA grants Hernexeo Breakthrough Therapy designation as first line use for HER2-mutant advanced NSCLC

Arjan Gower receives NCCN grant to study a targeted therapy for early-stage NSCLC with rare EGFR mutations

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