EC approves Opdivo + Yervoy as first-line treatment for HCC

FDA accepts sBLA for Opdivo + Yervoy in CRC

FDA accepted Bristol Myers Squibb’s supplemental biologics license application for Opdivo (nivolumab) plus Yervoy (ipilimumab) as a potential first-line treatment option for adult and pediatric patients (12 years and older) with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.

February 28, 2025

Vol.51 No.08

Clinical Roundup

Opdivo + chemo improves OS in resectable lung cancer, phase III study shows

Bristol Myers Squibb announced the final analysis of overall survival from the phase III CheckMate-816 study, which evaluated Opdivo (nivolumab) in combination with platinum-doublet chemotherapy as a neoadjuvant treatment for adult patients with resectable (tumors ≥ 4 cm or node positive) non-small cell lung cancer.

February 21, 2025

Vol.51 No.07

Drugs & Targets

EC grants marketing authorization for Removab as a treatment for malignant ascites

The European Commission granted marketing authorization for Removab (catumaxomab), making the drug the only approved drug therapy for malignant ascites for patients living with this debilitating condition across Europe.

February 14, 2025

Vol.51 No.06

Clinical Roundup

Opdivo + Yervoy show improvement in PFS for MSI-high, MMR- CRC in phase III trial

Bristol Myers Squibb announced results of an analysis from the three-arm phase III CheckMate-8HW trial evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) versus Opdivo monotherapy across all lines of therapy, including first-line, for the treatment of microsatellite instability-high/mismatch repair-deficient metastatic colorectal cancer. At a median follow-up of 47 months, Opdivo plus Yervoy demonstrated a statistically significant and clinically meaningful improvement in the dual-primary endpoint of progression-free survival as assessed by Blinded Independent Central Review versus Opdivo monotherapy (HR 0.62; 95% CI 0.48–0.81; P = 0.0003).

January 31, 2025

Vol.51 No.04

Drugs & Targets

FDA approves Opdivo and Opdivo Qvantig for subcutaneous injection

FDA approved Opdivo (nivolumab) and Opdivo Qvantig (hyaluronidase-nvhy) for subcutaneous injection across approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.

January 10, 2025

Vol.51 No.01

Drugs & Targets

EC approves Opdivo + Yervoy as first-line treatment for MSI-H or dMMR metastatic CRC

The European Commission has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with microsatellite instability-high or mismatch repair deficient unresectable or metastatic colorectal cancer.

January 10, 2025

Vol.51 No.01

EC approves Opdivo + Yervoy as first-line treatment for HCC

YOU MAY BE INTERESTED IN

FDA accepts sBLA for Opdivo + Yervoy in CRC

Opdivo + chemo improves OS in resectable lung cancer, phase III study shows

EC grants marketing authorization for Removab as a treatment for malignant ascites

Opdivo + Yervoy show improvement in PFS for MSI-high, MMR- CRC in phase III trial

FDA approves Opdivo and Opdivo Qvantig for subcutaneous injection

EC approves Opdivo + Yervoy as first-line treatment for MSI-H or dMMR metastatic CRC

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