Opdivo receives positive CHMP opinion for early stage melanoma

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

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

Drugs & Targets

FDA approves neoadjuvant/adjuvant Opdivo for resectable NSCLC

FDA approved Opdivo (nivolumab) with platinum-doublet chemotherapy as neoadjuvant treatment, followed by single-agent Opdivo after surgery as adjuvant treatment, for adults with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements.

October 04, 2024

Vol.50 No.37

Regulatory News

ODAC votes overwhelmingly in support of PD-L1 expression as predictive biomarker for efficacy of checkpoint inhibitors
Vote applies across drugs and indications

The FDA Oncologic Drugs Advisory Committee on Sept. 26 voted that PD-L1 inhibitors should not be indicated for patients with PD-L1-negative gastric/gastroesophageal junction adenocarcinoma and esophageal squamous cell carcinoma.

September 27, 2024

Vol.50 No.36

By Jacquelyn Cobb

Opdivo receives positive CHMP opinion for early stage melanoma

YOU MAY BE INTERESTED IN

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

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

FDA approves neoadjuvant/adjuvant Opdivo for resectable NSCLC

ODAC votes overwhelmingly in support of PD-L1 expression as predictive biomarker for efficacy of checkpoint inhibitors
Vote applies across drugs and indications

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Opdivo receives positive CHMP opinion for early stage melanoma

YOU MAY BE INTERESTED IN

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

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

FDA approves neoadjuvant/adjuvant Opdivo for resectable NSCLC

ODAC votes overwhelmingly in support of PD-L1 expression as predictive biomarker for efficacy of checkpoint inhibitorsVote applies across drugs and indications

Never miss an issue!

Login

ODAC votes overwhelmingly in support of PD-L1 expression as predictive biomarker for efficacy of checkpoint inhibitors
Vote applies across drugs and indications