Global

The EMA’s CHMP has issued a positive opinion supporting the approval of subcutaneous amivantamab in EGFR-mutated NSCLC.

The CHMP has recommended approval for durvalumab in limited-stage small cell lung cancer following platinum-based chemoradiation.

Datopotamab deruxtecan approaches approval in Europe as an option for patients with previously treated hormone receptor–positive breast cancer.

The EMA’s CHMP has adopted a positive opinion regarding frontline nivolumab plus ipilimumab in unresectable or advanced hepatocellular carcinoma.

China’s NMPA approved isatuximab plus VRd for newly diagnosed, transplant-ineligible multiple myeloma.

The EMA’s CHMP has recommended the approval of liso-cel for relapsed/refractory follicular lymphoma after at least 2 prior lines of therapy.

The European Commission has approved blinatumomab as consolidation therapy for Ph-negative, CD19-postive B-cell precursor acute lymphoblastic leukemia.

Updated phase 2 data revealed fruquintinib plus TAS-102 could offer survival benefits in pretreated metastatic colorectal cancer.

The EMA has accepted for review an MAA seeking the approval of nogapendekin alfa inbakicept plus BCG for BCG-unresponsive NMIBC with CIS.

The EMA’s CHMP has approved isatuximab in combination with VRd for transplant-ineligible patients with newly diagnosed multiple myeloma.

The European Commission approved first-line amivantamab plus lazertinib for EGFR-mutated advanced non–small cell lung cancer.

The Fortel PSA Screening Test has been approved by the United Arab Emirates MOHAP for the rapid detection of early signs of prostate cancer.

Health Canada approved fruquintinib for select patients with metastatic colorectal cancer.

Frontline dostarlimab plus chemotherapy has been approved in the EU for all adult patients with primary advanced or recurrent endometrial cancer.

Senaparib has received marketing authorization in China as a first-line maintenance therapy for advanced ovarian cancer.

Limertinib was approved in China for locally advanced or metastatic non–small cell lung cancer harboring an EGFR T790M mutation.

First-line nivolumab plus chemotherapy numerically improved survival vs chemotherapy alone in Asian patients with unresectable/metastatic urothelial cancer.

Jun-Jie Li, MD, discusses the efficacy of neoadjuvant SHR-A1811, a HER2-directed antibody-drug conjugate, in HER2-positive breast cancer.

Savolitinib has received full NMPA approval for locally advanced/metastatic non–small cell lung cancer with MET exon 14 skipping alterations.

Adjuvant nivolumab plus chemoradiotherapy improved disease-free survival in resected, locally advanced head and neck squamous cell carcinoma.

China’s NMPA has approved isatuximab plus pomalidomide and dexamethasone in adult patients with pretreated multiple myeloma.

Enfortumab vedotin-efjv plus has received NMPA approval for patients with locally advanced or metastatic urothelial cancer.

A marketing authorization application has been submitted to the EMA seeking the approval of eflornithine for patients with high-risk neuroblastoma.

China’s NMPA has approved zolbetuximab plus chemotherapy for CLDN18.2-positive advanced gastric or GEJ adenocarcinoma.

Tarlatamab was granted conditional marketing authorization in the United Kingdom for previously treated extensive-stage small cell lung cancer.

China's NMPA has approved taletrectinib adipate capsule for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC.

China’s NMPA has granted priority review to the NDA for savolitinib plus osimertinib in pretreated EGFR-mutated advanced NSCLC with MET amplification.

The European Commission has approved a type II variation extended indication for lazertinib plus amivantamab in frontline EGFR-mutated NSCLC.

Here is your snapshot of all therapeutic options greenlit by the FDA in December 2024 spanning tumor types.

European approval is no longer being sought for Dato-DXd in advanced nonsquamous non–small cell lung cancer.