Global Oncology

The South Korean Ministry of Food and Drug Safety approved selinexor plus bortezomib and dexamethasone for pretreated patients with multiple myeloma.

The European Commission has granted orphan medicinal product designation to VCN-01 for the treatment of patients with retinoblastoma.

Toripalimab has been approved in India and China’s Hong Kong Special Administrative Region for recurrent or metastatic nasopharyngeal carcinoma.

China’s CDE has granted breakthrough therapy designation to first-line sunvozertinib for EGFR exon 20 insertion mutation–positive NSCLC.

A next generation sequencing–based companion diagnostic has received marketing approval in China for sunvozertinib in EGFR exon 20–positive NSCLC.

A Type II variation application has been submitted to the EMA for subcutaneous daratumumab plus VRd in newly diagnosed multiple myeloma.

LBL-024 received breakthrough therapy designation in China for pretreated advanced extrapulmonary neuroendocrine carcinoma.

Illuccix has been approved in Canada for the selection of patients with mCRPC eligible for treatment with PSMA1-targeted radionuclide therapy.

Dual HER2 blockade with trastuzumab plus pertuzumab may serve as an effective option for hormone receptor–positive, HER2-positive metastatic breast cancer.

The European Commission has approved toripalimab in indications for nasopharyngeal carcinoma and esophageal squamous cell carcinoma.

Enfortumab vedotin plus pembrolizumab has been approved in Japan for first-line radically unresectable urothelial carcinoma.

Japan’s Ministry of Health, Labour, and Welfare approved fruquintinib in metastatic colorectal cancer following progression with chemotherapy.

The CHMP has recommended the European approval of serplulimab for the first-line treatment of extensive-stage small cell lung cancer.

The EMA's CHMP has recommended the approval of subcutaneous daratumumab plus VRd in patients with newly diagnosed, transplant-eligible multiple myeloma.

The CHMP has issued positive opinions for 2 pembrolizumab-based regimens for select patients with endometrial and cervical cancers.

The EMA’s CHMP has recommended the marketing authorization of mirvetuximab soravtansine for FRα-positive, platinum-resistant epithelial ovarian cancer.

Tislelizumab has been approved by the Israeli Ministry of Health for pretreated patients with unresectable or metastatic esophageal squamous cell carcinoma.

Adding ribociclib to a NSAI in the adjuvant setting prolonged invasive and distant disease-free survival in HR-positive, HER2-negative early breast cancer.

Pembrolizumab continued to demonstrate improved survival vs ipilimumab in unresectable stage III or IV melanoma.

Ramucirumab plus trifluridine/tipiracil failed to improve overall survival vs TAS-102 alone in patients with heavily pretreated metastatic colorectal cancer.

Neoadjuvant pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab, improved overall survival in triple-negative breast cancer.

The addition of retifanlimab to carboplatin and paclitaxel prolonged PFS for patients with chemotherapy-naive recurrent or metastatic SCAC.

Tumor infiltrating lymphocytes may have prognostic utility for OS outcomes with adjuvant chemotherapy and trastuzumab in early HER2-positive breast cancer.

Pembrolizumab plus chemoradiotherapy improved survival in previously untreated, high-risk locally advanced cervical cancer.

The combination of encorafenib and binimetinib showed anti-tumor responses in treatment-naïve BRAF V600E-mutant advanced non–small cell lung cancer.